Sunday, October 2, 2011

How Do I Take Incivek-telaprevir ?


On November 4-12 the AASLD Annual Meeting will bring us new data on INCIVEK™
and VICTRELIS™.

Including updated information from a Phase 2 study evaluating the INCIVEK combination in people co-infected with HCV/HIV- genotype 1:all participants were not previously treated.

Bristol-Myers Squibb will be presenting the much anticipated data on their Interferon free combination -"Dual Oral Combination Therapy with the NS5A Inhibitor BMS-790052 and the NS3 Protease Inhibitor BMS-650032.


  • The first results of a Phase IIa study of the dual DAA regimen of BMS-790052 and the NS3 protease inhibitor BMS-650032 in HCV genotype 1b-infected patients who have not responded to prior alfa/RBV therapy (null responders), evaluating sustained virologic response 12 weeks post-treatment (SVR12)
You can view updates on the meeting here.

However, today its all about Incivek-telaprevir for the many people who may be starting therapy. Included in the information will be the dosing regimen for Incivek in combination with pegIFN/RBV, and a list of drugs that could cause drug interactions if used while taking Incivek. For instance in the medication guide, St. John's wort or products containing St. John’s wort can decrease the effectiveness of Incivek.

This information will include a comprehensive list of drugs that can lead to interactions with telaprevir, but lets start with a few drugs that you might be familiar with.

Antibiotics and Antidepressants

Antibiotics
Erythromycin which is used to treat certain infections caused by bacteria.
Telithromvcin-(Ketek®) used to treat certain types of pneumonia that is caused by bacteria.
Clarithromycin used to treat pharyngitis, tonsillitis, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, pneumonia, skin and skin structure infections. In addition, it is sometimes used to treat Legionellosis, Helicobacter pylori, and lyme disease.
Clarithromycin is available under several brand names, for example Crixan, Clarac, Biaxin, Klaricid, Klacid, Klaram, Klabax, Klacid, Claripen, Clarem, Claridar, Fromilid, Clacid, Clacee, Vikrol, Infex and Clariwin, Resclar.

A couple antidepressants also known as Benzodiazepine
Defined-The benzodiazepine family of depressants is used therapeutically to produce sedation, induce sleep, relieve anxiety and muscle spasms, and to prevent seizures.

Alprazolam-(Xanax®)
Midazolam- (Versed®)
Zolpidem - (Ambien®, Ambien CR®, Edluar™, Zolpimist®)

Take note that even grapefruit juice was mentioned. Please make sure that you discuss all your medications with your physician and pharmacist, do not rely solely on the list provided here today. Please take time to read the PDF provided by Vertex with the prescribing information.
*The PDF will explain all the drug interactions in detail.
The information compiled here is available @ CCO ,PDF-Prescribing information. and MedTV.

Telaprevir Dosing Guidelines for Hepatitis C

The recommended dosage for treating genotype 1 chronic hepatitis C is 750 mg-(Two 375mg tablets) three times a day. Telaprevir dose must not be reduced or interrupted. Doses should be given seven to nine hours apart. Telaprevir works best if it is taken at the same time each day.

Missing A Dose

If you miss a dose and remember the missed dose within 4 hours of the time you were scheduled to take it, take the missed dose with a snack or meal right away. However, if it is more than 4 hours since you were to take the dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. Call your doctor.

OVERDOSAGE
The highest documented dose administered is 1875 mg every 8 hours for 4 days in healthy subjects with INCIVEK alone. In that study, the following common adverse events were reported more frequently with the 1875 mg q8h regimen compared to the 750 mg q8h regimen: nausea, headache, diarrhea, decreased appetite, dysgeusia, and vomiting.

No specific antidote is available for overdose with INCIVEK. Treatment of overdose with INCIVEK consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. In the event of an overdose, it is reasonable to employ the standard supportive measures, such as, removing unabsorbed material from the gastrointestinal tract, employing clinical monitoring (including obtaining an electrocardiogram), and instituting supportive therapy if required.

Packaged

INCIVEKTM (telaprevir) is supplied as purple film-coated capsule-shaped tablets containing 375 mg of telaprevir. Each tablet is debossed with the characters “V 375” on one side and is packaged as follows:
28-day packer contains 4 weekly cartons of 7 blister strips each (6 tablets per blister strip)

Storage

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). After a bottle of telaprevir is first opened, the medication must be used within 28 days. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

The Rash
Serious Skin Reactions/Rash

Patients should be informed that INCIVEK combination treatment may cause rash. The rash can be severe and may be accompanied by fever and skin breakdown. Patients should promptly report any skin changes or itching to their healthcare provider. Patients should not stop INCIVEK due to rash unless instructed by their healthcare provider.

The rash is often mild and not serious in most cases. The advisory committee members were concerned about the three cases of Stevens Johnson Syndrome (SJS) which appeared during the telaprevir clinical trials. Keep in mind that there were approximately 2,200 trial participants. The serious skin reactions included a drug rash with eosinophilia and systemic symptoms known as (DRESS) and Stevens Johnson Syndrome (SJS). In the telaprevir trial the serious adverse reactions were reported in less then 1% , that is compared to none in the trial participants who received peginterferon alfa and ribavirin alone.

SCAR- Severe Cutaneous Adverse Reactions

Cutaneous drug reactions occur when your skin has a reaction to a drug.
DRESS is one of several terms that has been used to describe a severe idiosyncratic reaction to a drug that is characterized by a long latency of onset after exposure to the offending medication, a rash, involvement of internal organs, hematologic abnormalities and systemic illness.

Read more on the side effects during Telaprevir triple therapy- here" and all HCV therapy here.

If you haven't seen these yet, check out the two videos provided by Texas Medical Center discussing the side effects of standard therapy and a Patient video; Covering The New hepatitis C Drugs and Resistance .

Important Medication Information
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Take Telaprevir With Food

Telaprevir should be taken with a meal or snack that contains about 20 grams of fat. Do not take telaprevir without food. Examples of foods that contain about 20 grams of fat include:

  • A bagel with cream cheese

  • One half cup of nuts or trail mix

  • Three tablespoons of peanut butter

  • Two ounces of cheddar cheese.
First lets learn the lingo:

Defined; Response-Guided Therapy-Adjusting duration of therapy based on response.
Defined-Naive patients-never treated HCV before.
Defined-Relapsers: People whose viral load-(HCV RNA) drops to an undetectable level with treatment but rises again after treatment ends.
Defined- Partial response: At least a 2-log10 (100-times) drop in viral load-(HCV RNA), but inability to fully remove the virus from the blood by week 24.
Defined-Null responders: People who failed to reduce viral load-HCV RNA by at least a 2 log drop after 12 weeks of prior treatment, which is the currently recommended Food and Drug Administration (FDA) definition for clinical trials of investigational hepatitis C treatments.
Defined-Breakthrough :After dropping to undetectable levels, viral load-HCV RNA is detected again in blood during treatment.

What Is A 2 Log Drop?

Example: 2 log drop = 15,000,000 IU/Ml to 150,000 IU/mL; a viral load that starts at 15,000,000 IU/mL and does not decrease to 150,000 IU/mL or lower.

We begin with the treatment regimen for naive patients and relapsers, using response guided therapy. This includes people with compensated cirrhosis folks.

Treatment-naive patients and relapsers both RGT-response-guided therapy
*Response-Guided Therapy (RGT; Includes Compensated Cirrhotics)

Patients who have never treated before and relapsers with an undetectable viral load-HCV RNA at 4 and 12 weeks will be treated for a total of 24 weeks.
As Follows;
First 12 weeks with triple therapy- Telaprevir + pegIFN/RBV-
Additional 12 weeks with dual therapy - pegIFN/RBV alone
Total treatment time is 24 weeks

However:
For patients who have a detectable viral load lower then 1000 IU/mL at week 4 and12 total treatment time is @ 48 weeks
As Follows;
First 12 weeks with triple therapy- Telaprevir + pegIFN/RBV-
Additional dual therapy - pegIFN/RBV alone for 36 weeks
Total Treatment time 48 weeks.

*Treatment-naive patients with cirrhosis who have undetectable viral load-HCV RNA at Weeks 4 and 12 of telaprevir + pegIFN/RBV may benefit from an additional 36 weeks of pegIFN/RBV (48 wks total).

Next up Previous Partial or Null responders

As for previous partial or null responders treatment is as follows;
Treatment will begin with triple therapy-( Telaprevir + pegIFN/RBV) for 12 weeks
Dual therapy -pegIFN/RBV alone for an additional 36 weeks.
Total treatment time 48 weeks.

Now for the stopping rules-Or when your physician will discontinue therapy

If at week 4 and 12 your viral load-HCV RNA is more then 1000-IU/mL all treatment will be stopped.

If at week 24 you have a detectable viral load-HCV RNA pegIFN/RBV is discontinued.

At any time, for any reason pegIFN/RBV is stopped, then Telaprevir must be discontinued.

*In previously treatment-naive patients who responded well but still have detectable virus, some experts would continue pegIFN/RBV with HCV RNA monitoring.

Related Links;
Updated guidelines from the AASLD
DAAs promise great hope, but AASLD has expedited the writing and review of its practice guideline because those drugs do require a level of expertise for practitioners if optimum outcomes can be reached. In addition, treatment schedules will be complex and different for each DAA. The newly approved treatment schedules have more side effects than pegylated interferon and ribavirin, and should be managed carefully. The drugs are intended for use only in combination with pegylated interferon and ribavirin, and if not used in combination with those drugs, treatment will be ineffective and will cause emergence of antiviral-resistant mutants that could be difficult to treat subsequently.

Source; CCO pocket guide for using telaprevir or boceprevir.

Drug Interactions With Telaprevir

This list can be found @ MedTV

The following sections explain in detail the potentially negative reactions that can occur when telaprevir is combined with any of the drugs listed below.


Arrhythmia Medications

Telaprevir may increase blood levels of antiarrhythmic medications, potentially increasing your risk for serious side effects. Your healthcare provider will monitor you closely if you take these medications together.

Bosentan
Telaprevir can increase blood levels of bosentan, possibly increasing the risk for side effects. Your healthcare provider may choose to monitor you more closely if you take these medications together.

Calcium Channel Blockers
Telaprevir may increase blood levels of calcium channel blockers, possibly increasing your risk for side effects. Your healthcare provider may choose to monitor you more closely if you take these medicines together, and adjust your calcium blocker dosage if needed.

Certain Antibiotics
When telaprevir is taken with certain antibiotics, it can increase the blood levels of the antibiotics and telaprevir. Your healthcare provider will closely monitor you for potential side effects if you take these medications together.

Certain Antifungal Medications
Telaprevir may increase blood levels of certain antifungal medications, potentially increasing your risk for serious side effects. In addition, the antifungals listed above can increase blood levels of telaprevir. High ketoconazole and itraconazole doses should not be given to people who are taking telaprevir. Because of unpredictable effects on voriconazole blood levels, it should not be used at all in people taking telaprevir, unless absolutely necessary.

Certain Anti-Seizure Medications
Taking telaprevir with certain anti-seizure medications can affect the blood levels of telaprevir and of the seizure medicines. Telaprevir may increase blood levels of carbamazepine, and could increase or decrease blood levels of phenytoin and phenobarbital. In addition, any of those seizure medications may decrease telaprevir blood levels, potentially making it less effective. Talk to your healthcare provider before taking these medications together.

Certain Benzodiazepines
Telaprevir can increase blood levels of alprazolam and midazolam, potentially increasing your risk for side effects. It can also decrease blood levels of zolpidem.

Talk to your healthcare provider before taking telaprevir with one of these medicines. He or she may need to adjust the dose of your benzodiazepine or sedative. Oral midazolam and telaprevir should not be taken together. Injectable midazolam should only be given with telaprevir in a healthcare setting, where appropriate monitoring is possible.

Certain Immunosuppressants

Telaprevir can increase blood levels of cyclosporine, tacrolimus, and sirolimus, possibly increasing the risk for side effects. If you take these medications together, your healthcare provider will need to monitor you more closely for potential side effects. He or she will check your blood levels of your immunosuppressant, and decrease your dose as necessary.

Colchicine
Combining telaprevir with colchicine could increase the levels of colchicine in your body, increasing your risk for potentially serious side effects. People with kidney and liver disease (other than hepatitis C) should not take these medicines together. If they are taken together, a lower colchicine dose should be used.

Corticosteroids
Combining telaprevir with corticosteroids could result in increased levels of corticosteroids in the bloodstream, which could increase your risk for potentially serious side effects. INVICEK should not be used with oral, inhaled, or nasal corticosteroid medicines unless absolutely necessary.

CYP 3A4 Inhibitor Medications
The liver breaks down telaprevir using enzymes known as CYP 3A4 enzymes. Medications known as CYP 3A4 inhibitors can decrease the activity of these enzymes. Combining telaprevir with one of these CYP 3A4 inhibitors may increase the level of telaprevir in your bloodstream, increasing your risk for side effects. Talk to your healthcare provider before taking telaprevir with a CYP 3A4 inhibitor.

Digoxin
Telaprevir may increase levels of digoxin in the bloodstream. Your healthcare provider may decide to monitor your digoxin levels using a simple blood test, especially when you first start or stop taking telaprevir.

Desipramine
Taking telaprevir with desipramine could increase the level of desipramine in your bloodstream, potentially increasing your risk for side effects, such as nausea, dizziness, and low blood pressure. Your healthcare provider may need to give you a lower desipramine dose during telaprevir treatment.

Escitalopram
Telaprevir can decrease blood levels of escitalopram, potentially making it less effective. Although this is not considered a serious interaction, your healthcare provider may choose to monitor you more closely during telaprevir treatment and increase your escitalopram dose if needed.

Hormonal Birth Control
Telaprevir has been shown to decrease blood levels of ethinyl estradiol, which could make birth control pills that contain estrogen less effective. Women taking telaprevir should use two forms of birth control, other than hormonal birth control.


Methadone
Taking telaprevir with methadone could decrease levels of methadone in your bloodstream, potentially making it less effective. Your healthcare provider may choose to monitor your response to methadone, and adjust your dose if needed.

Non-Nucleoside Reverse Transcriptase Inhibitors
Combining telaprevir with efavirenz may result in lower blood levels of both efavirenz and telaprevir, possibly decreasing the effectiveness of the medications. Combining telaprevir with tenofovir may cause increased levels of tenofovir in the bloodstream, which could increase the risk for tenofovir side effects. Your healthcare provider will need to monitor you more closely if you take these medications together.

P-Glycoprotein (Pgp) Inhibitors
P-glycoprotein is a protein found in the body. One of its roles is to help remove substances, such as medications, out of the tissues so they can be excreted through the urine or feces. Pgp helps remove telaprevir from the body. Certain other medications (known as Pgp inhibitors) decrease the activity of Pgp.

Taking telaprevir with one of these Pgp inhibitors causes telaprevir to be removed more slowly, potentially increasing the amount of telaprevir in your bloodstream and increasing your risk for serious side effects. Your healthcare provider may choose to monitor you more closely for side effects if you take telaprevir with a Pgp inhibitor.

Phosphodiesterase Type-5 (PDE5) InhibitorsTaking telaprevir with a PDE5 inhibitor may increase the level of the PDE5 inhibitor in your bloodstream, potentially increasing your risk for side effects. Talk to your healthcare provider before taking these medications together.

Protease Inhibitors
Combining telaprevir with other protease inhibitors can decrease blood levels of telaprevir, while having varying effects on blood levels of the other protease inhibitors. For this reason, it is recommended that these medicines not be used together.

RifabutinRifabutin can decrease levels of telaprevir in your bloodstream, potentially making it less effective. Telaprevir may increase blood levels of rifabutin, potentially increasing your risk for side effects. It is recommended that these medicines not be used together.

Salmeterol
Telaprevir may increase blood levels of salmeterol, possibly increasing your risk for potentially serious side effects, including heart rhythm problems. You should not take salmeterol with telaprevir.

Trazodone
Taking telaprevir with trazodone could increase the level of trazodone in your bloodstream, potentially increasing your risk for side effects, such as nausea, dizziness, and low blood pressure. Your healthcare provider may need to give you a lower trazodone dose during telaprevir treatment.

Warfarin
Telaprevir can alter blood levels of warfarin. Your healthcare provider should monitor you more closely (by checking your INR) if you take warfarin with telaprevir.

Final Thoughts
I is possible that not all telaprevir drug interactions were discussed in this article. Therefore, you should talk with your pharmacist or healthcare provider about the specific interactions that may apply to you.

The List;

Telaprevir (INCIVEK™) may react with a number of other medications.
Some of the drugs that can lead to interactions with telaprevir include but are not limited to:
  • Arrhythmia medications, such as:
Amiodarone (Cordarone®, Pacerone®)

    • Flecainide (Tambocor™)

    • Lidocaine

    • Propafenone (Rythmol®, Rythmol® SR)

    • Quinidine



  • Certain antibiotics, such as:


  • Certain antifungal medications, such as:

    • Itraconazole (Sporanox®)

    • Ketoconazole (Nizoral®)

    • Posaconazole (Noxafil®)

    • Voriconazole (VFEND®)

  • Certain anti-seizure medications, such as:


  • Certain benzodiazepines and sedatives, such as:


  • Certain immunosuppresants, such as:



    • Betamethasone (Celestone®)

    • Cortisone

    • Dexamethasone (Decadron®)

    • Fludrocortisone (Florinef®)

    • Hydrocortisone (Cortef®)

    • Methylprednisolone (Depo-Medrol®, Medrol®)

    • Prednisolone (Ovapred®, Pediapred®)

    • Prednisone

    • Triamcinolone (Kenalog®, Aristospan®)
CYP 3A4 inducer medications, such as:


  • CYP 3A4 inhibitor medications, such as:



    • Delavirdine (Rescriptor®)

    • Efavirenz (Sustiva®)

    • Nevirapine (Viramune®)

    • Tenofovir (Viread®)

  • -glycoprotein inhibitors, such as:

    • Amiodarone (Cordarone®, Pacerone®)

    • Atorvastatin (Lipitor®, also found in Caduet®)

    • Carvedilol (Coreg®, Coreg CR®)

    • Clarithromycin (Biaxin®)

    • Cyclosporine (Gengraf®, Neoral®, Sandimmune®)

    • Darunavir (Prezista®)

    • Dipyridamole (Persantine®, also found in Aggrenox®)

    • Dronedarone (Multaq®)

    • Erythromycin

    • Grapefruit juice

    • Itraconazole (Sporanox®)

    • Ketoconazole (Nizoral®)

    • Lapatinib (Tykerb®)

    • Lopinavir and ritonavir (Kaletra®)

    • Mefloquine (Lariam®)

    • Nelfinavir (Viracept®)

    • Nicardipine (Cardene®)

    • Nilotinib (Tasigna®)

    • Progesterone

    • Propranolol (Inderal®, Inderal LA®, InnoPran XL®, also found in Inderide®)

    • Quinidine

    • Ranolazine (Ranexa®)

    • Reserpine

    • Ritonavir (Norvir®, also found in Kaletra®)

    • Saquinavir (Invirase®)

    • Sunitinib (Sutent®)

    • Tacrolimus (Prograf®, Protopic®)

    • Tamoxifen (Nolvadex®)

    • Verapamil (Calan®, Calan SR®, Covera-HS®, Isoptin SR®, Verelan®, Verelan PM®)
    • Phosphodiesterase type-5 (PDE5) inhibitors, such as:

  • Protease inhibitors, such as:

    • Atazanavir (Reyataz®)

    • Darunavir (Prezista®)

    • Fosamprenavir (Lexiva®)

    • Lopinavir and ritonavir (Kaletra®)

    • Ritonavir (Norvir®)


In closing I would like to add that HCV advocate and their newsletters provide easy to understand clinical data and treatment information.
When I was diagnosed over a decade ago, these newsletters were my window into understanding HCV, may you find them as beneficial as I did.

Remember this, call the doc whenever you feel something isn't right, do not hesitate. You know your mind and body better then anyone.

Wishing you all a safe and successful journey.

Tina
Posted by at No comments:
File Under

Video-Side Effects Of Hepatitis C Treatment Oct 2011

Uploaded by on Oct 1, 2011

Dr. Saira Khaderi, with Liver Specialists of Texas, discussed side effect management of hepatitis C treatment. In the video, the topics of flu-like symptoms, fever, headache, diabetes, and hypertension are discussed. These videos are part of an educational video series produced by Dr. Joseph S. Galati and his hepatitis C team, providing patients with hepatitis C, their family members and caretakers, and other health professionals, up to date information of how to best deal with the well know side effects of hepatitis C treatment.

Liver Specialists of Texas is located in the Texas Medical Center, Houston, Texas, and is one of the most experienced centers in the country treating hepatitis C patients.





Uploaded by on Sep 25, 2011

In this video, Lauren Thomas, RN, Nurse Practitioner with Liver Specialists of Texas, discusses the common side effects associated with Hepatitis C therapy. Topics included are anemia, infections, hair loss, skin complications, gastrointestinal side effects, scheduling of appointments, serious complications, the need for family support, bone marrow suppression, and mouth/dental complications. Liver Specialists of Texas, located in Houston, is one of the most experienced practices treating patients with hepatitis C and chronic liver disease.


Posted by at No comments:
File Under ,

Saturday, October 1, 2011

Hepatitis News Ticker; Important new liver research

Jason Waskey; Mim reading-view gallery

The findings from the Centenary Institute and Concord Hospital in Sydney could make transplantation easier; enable hepatitis C to be treated more effectively and maybe also autoimmune diseases like insulin dependent diabetes and rheumatoid arthritis.




Scientists at the Centenary Institute and Concord Hospital in Sydney have found that our liver is a black hole for rogue immune cells. Read Transcript

Deferasirox Can Improve Liver Fibrosis, Necroinflammation

By: MARY ANN MOON, Internal Medicine News Digital Network

Oct 1

Treatment with the iron chelator deferasirox for at least 3 years stabilized or improved liver fibrosis and necroinflammation and also reduced serum alanine aminotransferase levels in patients with beta-thalassemia and iron overload, Dr. Yves Deugnier and his colleagues reported in the October issue of Gastroenterology.

This improvement occurred independently of patients’ treatment response as measured by liver iron concentration, which suggests that some of the drug’s benefit is independent of its iron-clearing ability. The improvements also were seen regardless of patients’ hepatitis C virus (HCV) antibody status at baseline, said Dr. Deugnier of University Hospital Pontchaillou in Rennes, France, and his associates (Gastroenterology 2011 October [doi:10.1053/j.gastro.2011.06.065]).

"To our knowledge, this is the first analysis which demonstrates regression of fibrosis in patients with beta-thalassemia during iron chelation therapy," they noted. The study was sponsored by Novartis, maker of deferasirox.

"The overall improvement in liver fibrosis and necroinflammation with deferasirox treatment seen in this study is striking," given that there is scant evidence in the literature that any medication can reverse fibrosis.

The investigators performed a secondary analysis of data on 219 subjects participating in two 1-year trials. One trial involved patients with beta-thalassemia major who had received 1 year of either deferasirox or deferoxamine therapy, and the other involved patients with various transfusion-dependent anemias, including beta-thalassemia, who had received 1 year of treatment with deferasirox.

In Dr. Deugnier’s study, the subjects with beta-thalassemia were followed as they continued on deferasirox after the trials concluded, because the data collected so far showed that a 1-year course of therapy may not be long enough to reveal changes in the extent or severity of fibrosis.

All the study subjects were at least 2 years of age at baseline and were receiving eight or more blood transfusions per year. All underwent liver biopsy at baseline and after 3 years of deferasirox treatment, and 210 had evaluable biopsy samples.

A total of 134 patients were classified as response successes on the basis of their liver iron concentrations, while the other 76 were deemed to be response failures by this measure.

However, fibrosis staging scores improved in both groups – the response successes and failures. Overall, 122 patients, 56% of the entire study population, showed stabilization of liver fibrosis and another 59 (27%) showed regression of fibrosis.

Fibrosis stabilized in 60% of response successes and 49% of response failures, while it regressed in 26% of response successes and 30% of response failures.

This lack of correlation between liver iron concentrations and improvements in fibrosis suggests that deferasirox’s effect on fibrosis may be independent of its ability to remove iron. It is possible that the drug exerts a direct effect on the pathophysiologic mechanisms that moderate fibrosis, the researchers said.

"Recent studies have shown an inhibitory effect of deferasirox on the transcriptional nuclear factor NF-KB35, a protein which also has been shown to be implicated in the development of fibrosis of the lung. Further molecular biology studies are required to explore this hypothesis," they noted.

Deferasirox also improved liver fibrosis regardless of subjects’ HCV status. The fibrosis stabilized in 47% of HCV-positive and 57% of HCV-negative patients, and it regressed in 30% of HCV-positive and 27% of HCV-negative patients. Thus, infection with this virus does not appear to diminish the drug’s effectiveness.

Ishak necroinflammatory grading scores improved by a mean of 1.3 points in the study population overall. As with fibrosis, inflammation did not correlate with liver iron concentrations. And as with fibrosis, necroinflammatory scores improved in both HCV-positive and HCV-negative patients.

Patients who took deferasirox showed a mean decrease from 40.9 to 29.6 IU/L in mean serum alanine aminotransferase (ALT), a marker of hepatocellular damage. Improvements in ALT correlated with decreases in liver iron concentrations, so that only patients classified as response successes by this measure showed significant reductions in ALT as well.

The study findings "are encouraging and warrant further studies to investigate the potential effects of deferasirox in preventing iron-induced tissue fibrosis in organs other than the liver, such as endocrine organs or the heart. In support of this concept, recent preclinical data in which deferasirox treatment was administered to an iron-overloaded gerbil model were associated with attenuated cardiac fibrosis," Dr. Deugnier and his colleagues wrote.

Most of the authors disclosed relationships with Novartis; several authors are employees of the company and others receive honoraria, lecture fees, or grants from Novartis.


By: MARY ANN MOON, Internal Medicine News Digital Network

Oct 1

In patients who have chronic hepatitis C and undergo liver biopsy, the presence of Mallory-Denk bodies – hepatocyte cytoplasmic inclusions that occur in several chronic liver diseases – is independently associated with progression of liver fibrosis, Dr. Mina O. Rakoski and her colleagues reported in the October issue of Clinical Gastroenterology and Hepatology.

In addition, patients in whom serial liver biopsies show an increase in the number of Mallory-Denk bodies over time are more likely to have clinical decompensation and progression to cirrhosis than patients who have no Mallory-Denk bodies or who have a stable or decreasing number of them over time.

Little is known about Mallory-Denk bodies, and it is still unclear whether they "represent a benign epiphenomenon of hepatocyte injury" or are actual modifiers of disease progression. Their major constituents are keratin polypeptides 8 and 18, which "likely play an essential cytoprotective role in the liver," said Dr. Rakoski of the University of Michigan, Ann Arbor, and her associates.

In mice, gender and genetic background play critical roles in the formation of Mallory-Denk bodies. In humans, genes that encode keratin, including KRT8 and KRT18, have been associated with susceptibility to end-stage liver disease, increased fibrosis in chronic hepatitis C, and increased severity of primary biliary cirrhosis, they noted.

To explore the potential prognostic value of Mallory-Denk bodies in biopsy samples, Dr. Rakoski and her colleagues analyzed data from the HALT-C (Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis) trial. This was a multicenter prospective randomized controlled trial involving 1,050 patients with chronic hepatitis C and advanced fibrosis or cirrhosis.

The HALT-C study subjects underwent liver biopsy at baseline, 18 months, and 3 years, and were followed for a median of 6 years to track their clinical and histologic outcomes. The presence or absence of Mallory-Denk bodies was recorded by expert pathologists reviewing the biopsy samples.

A total of 158 subjects (15%) had Mallory-Denk bodies present in baseline biopsy samples. Their presence was associated with laboratory markers of severe disease, including low platelets, low albumin, high AFP, and high AST/ALT ratio. It also was associated with histologic markers of severe disease, including greater periportal fibrosis, greater pericellular fibrosis, steatosis, and higher inflammation scores.

A subset of 844 HALT-C patients was studied longitudinally, and 719 of these patients showed no Mallory-Denk bodies on baseline biopsy. In all, 61 of these subjects (8.5%) did show Mallory-Denk bodies on repeat biopsy ("MDB gain").

MDB gain was significantly associated with increased fibrosis and steatosis on repeat biopsy, as well as with diabetes, female gender, and Hispanic ethnicity. The association with gender and ethnicity suggest that genetic factors play an important but as yet unknown role in MDB formation.

Of 125 patients who had Mallory-Denk bodies on baseline biopsy, 101 (81%) showed fewer inclusions on repeat biopsy ("MDB loss"). This loss was associated with a lower BMI, less baseline fibrosis, the absence of diabetes, and the absence of smoking.

It is unknown why some patients showed MDB loss over time, nor why these patients did not show improved outcomes. It is possible that the loss of MDB actually reflected liver sampling errors. It also is possible that some unknown environmental or genetic factor caused the resolution of the inclusions but did not impact overall outcomes, Dr. Rakoski and her colleagues said.

In a subset of 58 patients with MDB gain over time, half developed an adverse clinical outcome. In contrast, only 15% of subjects who did not have MDB developed an adverse clinical outcome, a significant difference.

By comparison, in a subset of 88 patients with MDB loss over time, 23% developed an adverse clinical outcome, whereas 32% of those who did not have MDB loss developed an adverse clinical outcome – a nonsignificant difference. Thus, MDB loss was not associated with either good or adverse clinical outcomes.

Histologic outcomes also were assessed in a subset of 447 patients in the longitudinal analysis. In all, 67% of those who showed MDB gain over time developed an adverse histologic outcome, compared with only 28% of patients who did not show MDB gain over time. This difference was highly significant.

This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the National Center for Minority Health and Health Disparities, the National Center for Research Resources, and Hoffmann-La Roche (now Genentech). The investigators reported no conflicts of interest.


Date: 01 Oct 2011 -Liver re-transplantation generally has an inferior outcome compared with a patient's first transplant, due to the technical demands of the surgery and because patients are often sicker than they were at the time of their first procedure.

UCLA researchers, basing their work on 26 years worth of patient data from UCLA, sought to develop a scoring system for risk stratification of patients in need of a liver re-transplant, in the hopes of improving patient selection for scarce livers......


HCV Advocate Newsletter
October 2011

HCV Advocate Newsletter
October 2011
Click Here

In This Issue:
Pharmasset: 98% to 100% Cure Rates

Alan Franciscus, Editor-in-Chief

HealthWise: Reducing the Cost of Hepatitis C Treatment
Lucinda K. Porter, RN

Disability & Benefits: Medicare Enrollment Explained
Jacques Chamber, CLU

HCV Snapshots
Lucinda K. Porter, RN

Clinical Trials
Alan Franciscus, Editor-in-Chief


E. coli and its sometimes deadly result Hemolytic Uremic Syndrome (HUS) - What is it?

October 01, 2011

What is Hemolytic Uremic Syndrome?

Hemolytic uremic syndrome is a severe, life-threatening complication of an E. coli bacterial infection that was first described in 1955, and is now recognized as the most common cause of acute kidney failure in childhood. E. coli O157:H7 is responsible for over 90% of the cases of HUS that develop in North America. In fact, some researchers now believe that E. coli O157:H7 is the only cause of HUS in children. HUS develops when the toxin from E. coli bacteria, known as Shiga-like toxin (SLT) [1,2], enters cells lining the large intestine. The Shiga-toxin triggers a complex cascade of changes in the blood. Cellular debris accumulates within the body’s tiny blood vessels and there is a disruption of the inherent clot-breaking mechanisms. The formation of micro-clots in the blood vessel-rich kidneys leads to impaired kidney function and can cause damage to other major organs...continue reading..


September 26, 2011 — Risk for depression may decrease as coffee consumption increases, new research suggests.

September 26, 2011 — Risk for depression may decrease as coffee consumption increases, new research suggests.

In a 10-year cohort study of more than 50,000 older women, investigators found that compared with those who drank 1 cup or less of caffeinated coffee per week, those who drank 2 to 3 cups per day had a 15% decreased risk for depression, and those who drank 4 cups or more had a 20% decreased risk.

"This is one of the first major studies to look to this relationship," lead author Michel Lucas, PhD, RD, epidemiologist/nutritionist at Harvard School of Public Health in Boston, Massachusetts, told Medscape Medical News.. continue reading

Arch Intern Med. 2011;171:1571-1578. Abstract


Worth A Look

Liver Serum

Triple Therapy Experience

Hepatitis C Blog



Posted by at No comments:
File Under , ,

HCV-Listeria Outbreaks, Tainted wipes; Its Personal


Greetings folks, another wonderful weekend is upon us, time for relaxing and spending time with family. Most weekends you can find this blogger playing with my grandchild. I am one delighted grandma, that's an understatement.

The Good News
I am so excited that my daughter is about to give birth to my new grandchild, I could slap myself.

The Not So Good News
However, during this pregnancy my daughter has been screening her phone calls, why? I have no idea.

Well, it could be because she receives far too many unmanageable emotional phone calls from some woman who gave birth to her.

Just saying.

I can't help myself, each morning when I scan the health news for this blog, I frequently run across yet another recall or warning that my daughter needs to know about. Although I attempted to cut down the phone calls to listeria outbreaks only, its complicated. As any grandmother knows listeria can cause problems for both the mother and the baby. When a fetus is infected with listeria, it may be born prematurely or ... worse.

Pregnant women are more susceptible to it than non-pregnant healthy adults, and for certain vulnerable people, the illness could be fatal. Its become personal for me, not only is my daughter at risk but so are my friends with HCV, and friends who received a liver transplant. When it includes our friends and loved ones, it really hits home .

As reported at medpage the recent listeriosis outbreak from tainted cantaloupes shipped from July 29 to Sept. 10 to 25 states, sickened at least 72 individuals, killing 13 of them, according to the FDA and CDC. It s been reported that the outbreak was the most serious in over a decade.

Listeria can be potentially harmful for the elderly and individuals with the following medical problems; diabetes, immunocomprised adults , leukemia, kidney disease, hogkins disease, systemic lupus erythematosus, all our friends with AIDS, diseases of the liver, especially transplant recipients and my pregnant daughter.

The current public health advice to vulnerable groups on preventing listeria is to avoid the following:- Prepacked or delicatessen sliced meats- Soft cheeses - brie, camembert and chevre (goat's cheese)- Smoked fish- All kinds of pate including vegetable varieties- Pre-prepared cooked and chilled meals- Pre-prepared sandwiches- Unpasteurized milk, and now lets add cantaloupes to that list.

The Reality

From Medpage
CDC: 1,000 Food-Borne Disease Outbreaks in a Year
Matt McMillen-September 8, 2011

The latest numbers from the CDC show the U.S. had more than 1,000 outbreaks of food-borne disease in a single year.

The CDC study includes reports of illness from 2008, the most recent year that information is available.

The outbreaks caused 23,152 cases of illness, nearly 1,300 hospitalizations, and 22 deaths. But because most food-borne illnesses go unreported, the actual numbers are much higher. The CDC estimates that contaminated food causes as many as 48 million illnesses annually.
According to the CDC, a food-borne outbreak occurs when two or more cases of a similar illness are caused by a common food. An average of 24 such outbreaks were reported from each state or territory in 2008.

The total number of outbreaks was 10% less than the average number reported from 2003 to 2007. The number of outbreak-related illnesses in 2008 was also lower, by 5%.
Seventeen of the outbreaks crossed state lines, according to the CDC. Nine of those were caused by salmonella. Health officials identified the contaminated foods in six of those outbreaks: cantaloupe, cereal, ground turkey, ground white pepper, jalapeño and serrano peppers, and peanut butter.

Restaurant and deli food caused just over half of the 868 outbreaks that could be tied to a single location. Home cooking accounted for 15%...continue reading..

While I'm on my rant, those recalls on tainted wipes manufactured by Triads parent company H&P, really hit home. The recalls started around January of 2011, ending with the death of a child, which was reported this August, too much. The recall touched us all, and became personal for the millions of people infected with HCV.

The prep pads were packaged with pegasys in the U.S . and Pegintron outside the U.S. The wipes were contaminated with a rare bacteria, Bacillus cereus. As reported by MSNBC , there were eight reports of fatalities, 11 infections and nearly 250 other problems associated with the prep pads.

The Prep Pads and My Grandchild

For this grandma who often attends to my grandbabies boo-boo's, it should be noted that this spring I had those prep pads on hand, I still get chills. When my little angel ran a bit too fast and fell, because grandma tempted him with chocolate Ho Hos, me bad, I used good old soap and water to make it all better, not a prep pad.

To me it's evident that the dangers of using the tainted wipes to clean a wound on a child is low. My grandchild is healthy and has no underlying disease, however the risk is unacceptable. The loving parents of Harrison were not so fortunate.


The heartbreaking death of a child


January 2011
Parents blame toddler's death on tainted wipes

The parents of a 2-year-old Houston boy who died from a rare infection are suing makers of recalled alcohol prep products, claiming contaminated wipes and swabs transmitted bacteria that caused his fatal case of meningitis.

Sandra and Shanoop Kothari say their lively, dark-eyed toddler, Harrison, was recovering just fine from surgery to remove a benign cyst from near his brain and spinal cord last fall. But the day before he was set to be discharged after a week's stay, he developed a sudden and severe infection that worsened rapidly, causing multi-organ failure that led to Harrison’s death on Dec. 1, 2010.

Cultures showed he succumbed to acute bacterial meningitis caused by Bacillus cereus, bacteria typically found in rare food poisoning outbreaks, but not in hospital infections.

The wipes were contaminated with Bacillus cereus.
Continue Reading..

As reported by MSNBC in February 2011
"It also reported on a 55-year-old Tennessee man who contracted endomyocarditis, allegedly after using a Triad pad packaged with Genentech's peginterferon alfa-2a drug for hepatitis C. The man survived but required cardiac valve replacement surgery in December, the website indicated. He too has filed suit against Triad, with Genentech also named as a defendant".

Another Recall

Ground Beef In The News

Yesterday we heard of yet another recall on ground beef due to E. Coli.

From;The Food Poison Journal
Manning Beef, LLC, a Pico Rivera, Calif. establishment, is voluntarily recalling approximately 80,000 pounds of beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.


This weekend published @ Forbes

The 5 deadliest food-borne illnesses & how to prevent them
Oct 2 2011

With Listeria suddenly all over today's headlines thanks to the deaths of 21 people sickened by eating contaminated cantaloupes (as of Sept. 28th), you're probably asking yourself why you've heard so little about this deadly food-borne bacteria, and how to protect yourself from it.

Sadly, though, Listeria is just one of many types of bacteria that have been sneaking their way into the food supply in recent years, triggering fears of an epidemic of food poisoning.

Here, the 5 deadliest types of food-borne bacteria and how to keep yourself and your family members safe....continue reading..


Those Ugly Bacterial Toxins

Food Poisoning-Who's Most At Risk?

Infants and the elderly are at greater risk for food poisoning.
Other risk factors include:Having a pre-existing medical condition, such as chronic kidney failure, liver disease, or diabetes

Taking antibiotic, antihistamine, or steroid medicines
Having sickle cell anemia and other problems with red blood cells
Weakened immune system, pregnant women and people over age 65 are most at risk
Traveling in an area where contamination is more likely

Common bacterial toxins include:
Usually bacteria and algae cause food poisoning, but poisonous plants and animals may also be the cause.

Common bacterial toxins include:

E. coli in undercooked hamburger, unpasteurized apple juice or cider, raw milk, contaminated water (or ice), vegetables fertilized by cow manure, or spread from person to person.

Symptoms- Escherichia coli (E. coli): hemorrhagic colitis (diarrhea with very little stool and large amounts of blood), occurring up to 3 days after eating contaminated food

E. coli


What is E. coli?

Escherichia coli (E. coli) are gram-negative bacteria that can survive in an environment with or without air (facultative anaerobes) and, depending on the environment, may or may not produce thin hair-like structures (flagella or pili) that allow the bacteria to move and to attach to human cells. These bacteria commonly live in the intestines of people and animals worldwide. There are many strains (over 700 serotypes) of E. coli. Most of the E. coli are normal inhabitants of the small intestine and colon and do not cause disease in the intestines (non-pathogenic).

Nevertheless, these non-pathogenic E. coli can cause disease if they spread outside of the intestines, for example, into the urinary tract (where they cause bladder or kidney infections), or into the blood stream (sepsis). Other E. coli strains (enterovirulent E. coli strains or EEC) cause "poisoning" or diarrhea even though they usually remain within the intestine by producing toxins or intestinal inflammation..more information.

Listeria monocytogenes (L. monocytogenes) in cole slaw, dairy products (mostly soft cheeses from outside the United States), and cold, processed meats

Symptoms-For healthy adults listeria is generally not a significant risk – exposure to it might cause mild flu-like symptoms or stomach problems. More serious infections generally cause serious gastrointestinal and flu-like symptoms, often with muscle ache and a stiff neck, or sometimes confusion and loss of balance. This can then lead to a meningitis-like inflammation around the brain or septicaemia. Listeria is generally treated with antibiotics, which need to be administered quickly in serious cases.

Listeria


How can it be prevented?
Meats should be thoroughly cooked, and raw fruit and vegetables washed. Uncooked meat should be stored separately, and products containing unpasteurised milk avoided. Another key element is good kitchen hygiene, both keeping hands and equipment clean, and consuming even refrigerated leftovers within a few days.

Salmonella spp. in poultry, beef, eggs, or dairy products

From Medicine Net
Salmonella (S.) is the genus name for a large number (over 2,500) of types of bacteria. Each type is distinctly identifiable by its specific protein coating. The types are otherwise closely related. Salmonella bacteria are rod-shaped, flagellated, Gram stain-negative, and are known to cause disease in humans, animals, and birds (especially poultry) worldwide. The two major diseases caused by Salmonella spp. are gastroenteritis and typhoid fever (typhoid and paratyphoid fevers) in humans.

Salmonella


Potential direct sources of Salmonella are pets such as pet turtles, dogs, cats, most farm animals, and humans that are infected or are carriers of the organisms.

Symptons- Salmonellosis (gastroenteritis characterized by nausea, vomiting, and diarrhea) is the most common disease caused by the organisms. Abdominal cramping also may occur. Salmonellosis thus produces the symptoms that are commonly referred to as food poisoning. Although food poisoning is usually a mild disease, the nausea, vomiting, and diarrhea can lead to dehydration and even death (about 500 per year in the U.S.).

Salmonella Entering the Intestinal Tract




Shigella spp. from raw vegetables or cool, moist foods (such as potato and egg salads) that are handled after cooking

Symptoms- fever, chills, bloody diarrhea

Shigella


What is shigellosis?
Shigellosis is an infectious disease caused by a group of bacteria called Shigella. Most who are infected with Shigella develop diarrhea, fever, and stomach cramps starting a day or two after they are exposed to the bacteria. The diarrhea is often bloody. Shigellosis usually resolves in 5 to 7 days. Persons with shigellosis in the United States rarely require hospitalization. A severe infection with high fever may be associated with seizures in children less than 2 years old. Some persons who are infected may have no symptoms at all, but may still pass the Shigella bacteria to others.

What sort of germ is Shigella?
The Shigella germ is actually a family of bacteria that can cause diarrhea in humans. They are microscopic living creatures that pass from person to person. Shigella were discovered over 100 years ago by a Japanese scientist named Shiga, for whom they are named. There are several different kinds of Shigella bacteria: Shigella sonnei, also known as "Group D" Shigella, accounts for over two-thirds of shigellosis in the United States. Shigella flexneri, or "group B" Shigella, accounts for almost all the rest. Other types of Shigella are rare in this country, though they continue to be important causes of disease in the developing world. One type found in the developing world, Shigella dysenteriae type 1, can cause deadly epidemics...more information

Staphylococcus aureus (S. aureus) in salad dressing, ham, eggs, custard filled pastries, mayonnaise, and potato salad (usually from the hands of food handlers)

Staphylococcus aureus is a common bacterium found on the skin and in the noses of up to 25% of healthy people and animals. Staphylococcus aureus is important because it has the ability to make seven different toxins that are frequently responsible for food poisoning.

Staphylococcus


What is staphylococcal food poisoning?
Staphylococcal food poisoning is a gastrointestinal illness. It is caused by eating foods contaminated with toxins produced by Staphylococcus aureus . The most common way for food to be contaminated with Staphylococcus is through contact with food workers who carry the bacteria or through contaminated milk and cheeses. Staphylococcus is salt tolerant and can grow in salty foods like ham. As the germ multiplies in food, it produces toxins that can cause illness. Staphylococcal toxins are resistant to heat and cannot be destroyed by cooking. Foods at highest risk of contamination with Staphylococcus aureus and subsequent toxin production are those that are made by hand and require no cooking. Some examples of foods that have caused staphylococcal food poisoning are sliced meat, puddings, some pastries and sandwiches.

What are the symptoms of staphylococcal food poisoning?
Staphylococcal toxins are fast acting, sometimes causing illness in as little as 30 minutes. Symptoms usually develop within one to six hours after eating contaminated food. Patients typically experience several of the following: nausea, vomiting, stomach cramps, and diarrhea. The illness is usually mild and most patients recover after one to three days. In a small minority of patients the illness may be more severe.
Click here for more information

C. jejuni in raw milk and chicken
Symptoms- Symptoms of food poisoning from Campylobacter usually occur 2 to 5 days after a person eats contaminated food, but may take up to 10 days to appear. The most common symptom of a Campylobacter infection is diarrhea, which is often bloody. Typical symptoms include:Diarrhea: Diarrhea ranges from mild to severe and is often bloody Fever Nausea Vomiting Abdominal pain Headache Muscle pain

C. jejuni



Campylobacter jejuni is the most common cause of bacterial foodborne illness in the United States. Over 6,000 cases of Campylobacter infection were reported in 2009 alone, but many cases are not reported to public health authorities. A 2011 report from the CDC estimates that Campylobacter causes approximately 845,000 illnesses in the United States each year.
Campylobacter is found most often in food, particularly in chicken. Food is contaminated when it comes into contact with animal feces. Any raw poultry may contain Campylobacter, including organic and “free range” products. In fact, studies have found Campylobacter contamination on up to 88 percent of chicken carcasses. Despite the commonness of Campylobacter, however, infections are usually isolated events, and widespread outbreaks are rare.
Two age groups are most commonly affected by Campylobacter: children under 5 years of age and young adults aged 15-29...more information

C. botulinum in improperly home canned foods (in children under 1 year of age, mostly from honey but also from corn syrup)

Symptoms weakness, blurred vision, sensitivity to light, double vision, paralyzed eye nerves,difficulty speaking and swallowing, paralysis that spreads downward, respiratory failure, death.
Click here for more information

Clostridium perfringens(C. perfringens) in meat and poultry dishes and gravies, mostly foods that were cooked more than 24 hours before eating and were not reheated well enough.

Symptoms of C. perfringens- Persons infected with C. perfringens develop watery diarrhea and abdominal cramps within 6 to 24 hours (typically 8-12). The illness usually begins suddenly and lasts for less than 24 hours. Persons infected with C. perfringens usually do not have fever or vomiting. The illness is not passed from one person to another.

Clostridium perfringens


What is Clostridium perfringens?
Clostridium perfringens (C. perfringens) is a spore-forming gram-positive bacterium that is found in many environmental sources as well as in the intestines of humans and animals. C. perfringens is commonly found on raw meat and poultry. It can survive in conditions with very little or no oxygen. C. perfringens produces a toxin that causes illness.

How common is C. perfringens food poisoning?
C. perfringens is one of the most common causes of foodborne illness in the United States. It is estimated that it causes nearly a million cases of foodborne illness each year...more information


Cirrhosis and Vibrio vulnificus Infection
Vibrio vulnificus Infection: Vibrio vulnificus is an organism that lives in salt-water, particularly in the Southeast Atlantic and the waters of the Gulf of Mexico. However, infections have been reported from all coastal areas in the United States. This infection can be acquired by eating raw or poorly cooked seafood (raw oysters, sushi) or by going in sea water with open skin sores. In patients with cirrhosis this infection can be lethal. Patients with cirrhosis should not eat raw seafood and should abstain from going in the ocean if open sores are present.

Download a PDF of this fact sheet
The Risk of Eating Raw Oysters or Clams Brochure

Fish poisoning causes nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache.

Common types of fish poisoning include:
Scombroid poisoning from bacteria in dark meat fish (tuna, bonito, skipjack, mahi-mahi, mackerel) that are not refrigerated well

Specific types of fish poisoning can cause other signs and symptoms, such as:

Ciguatera poisoning in tropical fish (grouper, surgeonfish, snapper, barracuda, moray eel, shark) that have eaten toxic plankton

Symptoms;Ciguatera (caused by toxins in some fish, including grouper, snapper, mackerel, and barracuda): numbness or tingling around the mouth, feeling of loose teeth, impaired touch sensation of hot as cold and cold as hot, itching, muscle and joint pain, slow heart rate, low blood pressure

Puffer fish poisoning from the organs and flesh of puffer fish

Symptoms- Pufferfish poisoning: numbness or tingling around the mouth, trouble coordinating movement, difficulty swallowing, excess saliva, twitching, loss of ability to talk, convulsions, paralysis that spreads upward, respiratory failure, death

Poisoning from shellfish that feed on certain algae

Symptoms- Shellfish poisoning (caused by toxins in algae that are then eaten by shellfish): numbness or tingling around the mouth or in the arms and legs, trouble swallowing, difficulty speaking.

Mushroom Poisoning

Mushroom poisoning occurs from eating wild poisonous mushrooms, especially Amanita phalloides.

Symptoms -Mushroom poisoning: affects the liver, the neurological system (brain), or the gastrointestinal tract, including symptoms such as stomach upset, delirium (confusion), vision difficulties, heart muscle problems, kidney failure, death of liver tissue, and death if left untreated


CDC-Foodborne diseases in the United States

Data and Methodological Differences, 2011 and 1999

The 2011 estimates of illnesses, hospitalizations, and deaths from foodborne disease in the United States reflect improvements made since 1999 in data quality and methodology. Perhaps most importantly, these new estimates identify and rank the most important bacteria, viruses and parasites (“pathogens”) responsible for causing foodborne illness. Going forward, CDC will use the 2011 data to develop estimates of the proportion of illnesses that can be attributed to specific foods. These more specific estimates can further inform policy and regulatory priorities to prevent future illnesses.

The following table highlights the major differences in data and methodology between the new estimates and those published in 1999, and how they affect the estimates of illnesses, hospitalizations, and deaths from foodborne diseases in the United States.

1999 Estimate 2011 Estimates Effects of Differences
2011 estimate of acute gastroenteritis illnesses: more precise

Used 1996–1997 FoodNet Population Survey and data from US studies done before 1980 Used three most recent FoodNet surveys conducted in 2000–2001, 2002–2003, and 2006–2007

5 times larger = 2011 sample size (>48,000) compared with 1999 estimates. Larger sample size resulted in more precise data.

Stricter definition reduced rate of acute gastroenteritis.

Greater number of respondents excluded reduced rate of acute gastroenteritis.

Respondents reporting any vomiting included in definition of acute gastroenteritis Respondents reporting vomiting for <1 day or whose illness did not restrict activities excluded from definition of acute gastroenteritis.
25% = Proportion of respondents excluded from estimate of acute gastroenteritis because they reported cough or sore throat 38% = Proportion of respondents excluded from estimate of acute gastroenteritis because they reported cough or sore throat
0.79 = Rate of acute gastroenteritis per person per year 0.60 = Rate of acute gastroenteritis per person per year 211 million in 1999 reduced to 178.8 million in 2011 = Decline in the estimate of the total number of acute gastroenteritis illnesses

2011 estimate focused on foodborne illnesses acquired in the United States
Included international travel–related illnesses. Excluded international travel–related illnesses. Estimates were limited to foodborne illnesses that were domestically acquired, which reduced the number of foodborne illnesses in 2011 vs 1999.
2011 estimate showed decline in proportion of illnesses determined to be foodborne
40% = Proportion of norovirus illnesses estimated to be foodborne 26% = Proportion of norovirus illnesses estimated to be foodborne

Because norovirus causes a large number of illnesses, this reduction resulted in a big drop in the proportion of illnesses from all known gastroenteritis pathogens estimated to be foodborne, which in turn reduced the proportion of unspecified illnesses that were estimated to be foodborne.

76 million in 1999 to 47.8 million in 2011 = Decline in the overall estimate of foodborne illnesses (Also due to a lower estimate of acute gastroenteritis)

36% = Proportion of known gastroenteritis pathogens and the unspecified agents estimated to be foodborne 25% = Proportion of the known gastroenteritis pathogens and the unspecified agents estimated to be foodborne
2011 estimate of illnesses caused by known pathogens: more accurate
15% = Proportion of survey respondents with bloody diarrhea seeking medical care 35% = Proportion of survey respondents with bloody diarrhea seeking medical care Higher, more accurate estimate of medical care-seeking was used in multipliers to correct for under-diagnosis, resulting in lower illness estimates for known pathogens.
12% = Proportion of respondents with non-bloody diarrhea. 18% = Proportion of survey respondents with nonbloody diarrhea seeking medical care
2011 estimate used "adjustment” multipliers specific for each pathogen
Generic multipliers used to adjust for underreporting based on similarity of symptoms for known pathogens. Pathogen-specific multipliers used to adjust for under-reporting and under-diagnosis. Pathogen-specific multipliers resulted in more precise estimates.
2011 estimate modeled uncertainty for generation of estimates
Point estimates calculated without modeling of uncertainty. Modeled uncertainty for each estimate, resulting in credible intervals for each number. Credible intervals indicate a 90% probability that the actual numbers fall within the stated ranges.


The 10 riskiest foods in America
Leafy greens top the list of FDA-regulated foods that can make you ill

Source- MSNBC Published in 2009

  • U.S. consumers have been bombarded with reports of contaminated food in recent years, from salmonella in peanut butter and spinach to E. coli in cookie dough and ground beef. Individually, the outbreaks are alarming, but collectively, they represent what the consumers' group Center for Science in the Public Interest calls "a perfect storm of unsafe food." A new CSPI report finds that the top 10 riskiest foods regulated by the federal Food and Drug Administration accounted for nearly 40 percent of all foodborne outbreaks in the U.S. between 1990 and 2006, spawning nearly 50,000 illnesses with symptoms ranging from stomach cramps and diarrhea to kidney failure and death. Using data from the Centers for Disease Control and Prevention, researchers tracked more than 1,500 separate, definable outbreaks involving not only high-risk foods like meat and dairy, but staples of a healthy diet, such as fruits and vegetables. These outbreaks are only the tip of the iceberg of foodborne illness. For every case of salmonella poisoning reported, for instance, the CDC estimates that another 38 cases go unreported.

    • Leafy greens
    Image: salad

    Can salad really be bad for you?
    Although considered a healthy food, nutritious greens can also be coated in disease-causing germs. The Center for Science in the Public Interest identified 363 separate outbreaks linked to leafy greens, making them the No. 1 entry on the top 10 list of riskiest FDA-regulated foods. Salads and other food items containing leafy greens — iceberg lettuce, romaine lettuce, leaf lettuce, butter lettuce, baby leaf lettuce, escarole, endive, spring mix, spinach, cabbage, kale, arugula or chard — accounted for 24 percent of the outbreaks, which sickened at least 13,568 people. Another pathogen appearing frequently in leafy greens is norovirus, which was linked to 64 percent of the outbreaks in leafy greens. Salmonella was responsible for another 10 percent. Contamination may be present from production and processing or through improper handling, such as inadequate handwashing.


    Eggs

    Eggs, a popular high-protein breakfast food, have been linked to 352 outbreaks. The majority of illnesses from eggs are associated with salmonella, which sickened 11,163 people from 1990 to 2006. Salmonella lives in the intestinal tracts of animals and birds and is transmitted to humans when animal feces contaminate a food item of animal origin (such as eggs). Regulations implemented in the 1970s have reduced salmonellosis infections. However, salmonella enteritidis, the most prevalent type of salmonella in eggs today, infects the ovaries of otherwise healthy hens and contaminates the eggs before the shells are formed. New regulations issued in July 2009 require the adoption of controls aimed at minimizing salmonella enteriditis in egg production. While proper cooking should destroy most pathogens, serving eggs raw – or "runny" – or leaving egg dishes at improper holding temperatures (such as on a breakfast buffet) can allow the salmonella to multiply.


  • Tuna

    Image: tuna

    Many consumers are familiar with warnings about tuna and methylmercury, but the fish has also been implicated in 268 outbreaks and 2,341 reported cases of foodborne illness. Tuna has been linked to scombroid, the illness caused by scombrotoxin. Fresh fish decay quickly after being caught and, if stored improperly, begin to release natural toxins that are dangerous for humans. Adequate refrigeration and handling can slow this spoilage, but the toxin cannot be destroyed by cooking. Symptoms of scombroid poisoning can include skin flushing, headaches, abdominal cramps, nausea, diarrhea, palpitations and loss of vision. In addition to scombrotoxin, norovirus and salmonella can also be related to tuna consumption. More than 65 percent of outbreaks linked to tuna occurred in restaurants.

  • Oysters

    Image: Oysters


    • Contaminated oysters can ruin more than just a gourmet dinner. Oysters have been linked to 132 outbreaks, with 3,409 reported cases of illness. Not surprisingly, the majority of outbreaks from oysters occurred in restaurants. Illnesses from oysters occur primarily from two sources: norovirus and vibrio. Although norovirus in other foods is usually associated with improper handling, oysters actually can be harvested from waters contaminated with norovirus. When served raw or undercooked, those oysters can cause gastroenteritis, an inflammation of the stomach and small or large intestines. Vibrio, a type of bacterium in the same family as cholera, can cause a severe illness, particularly in those with a compromised immune system, characterized by fever and chills, septic shock and blistering skin lesions and can even be fatal.

    Potatoes

    Image: potatoes

    Potatoes, often in the form of potato salad, were linked to 108 outbreaks, with 3,659 consumers reported to have been sickened by spuds since 1990. Salmonella is the most common pathogen, associated with nearly 30 percent of outbreaks, followed by E. coli at 6 percent. The presence of salmonella and E. coli in potato dishes could indicate cross-contamination from raw or cooked ingredients or possibly from raw meat or poultry during handling and preparation. Shigella and listeria also appear in outbreaks associated with potatoes. More than 40 percent of potato outbreaks were linked to foods prepared in restaurants and food establishments (including grocery stores and delis).

    Cheese

    Image: brie

    Cheese has been linked to 83 outbreaks involving 2,761 reported cases of illness since 1990, with salmonella the most common hazard. Cheese can become contaminated with pathogens during production or processing. Most cheeses are now made with pasteurized milk, lowering the risk of contamination. In August, California officials warned consumers about eating Latin American-style cheeses such as queso fresco or queso Oaxaca, which may be made by unlicensed manufacturers using unpasteurized milk that could contain harmful bacteria. Pregnant women should be particularly cautious about consumption of soft cheeses such as feta, brie, camembert, blue-veined and Mexican-style cheese, which can carry listeria. Listeriosis infection can lead to miscarriage. For the elderly, listeria can cause severe illnesses, with high rates of hospitalization and death

    Ice cream

    Image: Ice cream cone

    Whether served in a cone or in a cup, America's favorite frozen treat occasionally can carry a load of dangerous bacteria. Ice cream has been linked to 74 outbreaks involving 2,594 reported cases of illness from pathogens such as salmonella and staphylcoccus since 1990. Soft ice cream can be particularly hazardous to pregnant women. Listeria can survive on metal surfaces — such as the interior of soft ice cream machines — and may contaminate batch after batch of products.


    Image: Tomatoes

    Although tomatoes were wrongly implicated in a sweeping 2008 outbreak later linked to fresh jalapeno and Serrano peppers, they have caused at least 31 identified outbreaks and sickened 3,292 since 1990. The most common hazard associated with tomatoes is salmonella, which accounted for more than half of the reported outbreaks. Salmonella can enter tomato plants through the roots or flowers and can enter the tomato fruit through small cracks in the skin, the stem scar or the plant itself. Restaurants were responsible for 70 percent of all illnesses associated with tomatoes.

    Sprouts

    Image: Sprouts

    Sprouts are a popular way to add crunch to salads and in Asian dishes. As the popularity of sprouts increases, however, so too does the potential for foodborne illnesses. Sprouts have been implicated in 31 outbreaks involving 2,022 reported cases of illness since 1990. The CDC and the FDA recommended in 1999 that people at high risk for complications from salmonella and E. coli — such as the elderly, young children, and those with compromised immune systems — not eat raw sprouts. The most likely source of sprout contamination is the seeds that are used to grow the sprouts. Seeds may become contaminated in the field or during storage, and the warm and humid conditions required to grow sprouts are ideal for the rapid growth of bacteria.

    • Berries
      Image: strawberries

      Strawberries, raspberries, blackberries and other berry products have caused 25 outbreaks and sickened 3,397 since 1990. In 1997, more than 2.6 million pounds of contaminated strawberries were recalled after thousands of students across several states reported illnesses from eating frozen strawberries in their school lunches. Hepatitis A was the culprit, and contamination may have occurred through an infected farm worker, according to the CSPI report. That same year, raspberries imported from Guatemala and Chile were implicated in a cyclospora outbreak across five states. The resulting infection is a parasitic illness of the intestines, which can cause severe diarrhea, dehydration and stomach cramps and requires treatment with antibiotics.

      — Center for Science in the Public Interest

    Posted by at No comments:
    File Under ,
    Subscribe to: Posts (Atom)