Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Wednesday, June 6, 2018

FDA takes action against 53 websites marketing unapproved opioids

FDA News Release
FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

The U.S. Food and Drug Administration today announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.
Companies who fail to correct the violations, as outlined in the warning letters, may be subject to enforcement action, including product seizure or injunction.

"The FDA is taking additional steps to protect U.S. consumers from illicit opioids by targeting the websites that illegally market them and other illicit drugs. The internet is virtually awash in illegal narcotics and we’re going to be taking new steps to work with legitimate internet firms to voluntarily crack down on these sales. As part of that effort, we’re hosting a summit with internet stakeholders to find new ways to work collaboratively with them to address these issues. At the same time, we’ll be taking action against firms whose websites deliberately break the law," said FDA Commissioner Scott Gottlieb, M.D. "This illegal online marketing of unapproved opioids is contributing to the nation’s opioid crisis. Today’s warning letters go right to the source of this illegal activity to let online network operators know that marketing illegal and unapproved opioids directly to U.S. consumers will not go unchallenged by the FDA. Opioids bought online may be counterfeit and could contain other dangerous substances. Consumers who use these products take significant risk with their lives. The new warning letters are part of a comprehensive campaign to target illegal sales of unapproved opioids. We’ll be following these actions with additional steps in coming months to crack down on the flow of illegal, unapproved opioids sold online and shipped through the mail."

Patients who buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe. As noted in the warning letters, these websites offer for sale opioids that are misbranded and unapproved new drugs, including unapproved tramadol and oxycodone, in violation of the Federal Food, Drug, and Cosmetic Act.

This is particularly concerning considering that FDA-approved tramadol and oxycodone carry boxed warnings, which is the FDA’s most prominent warning, indicating that the drugs carry a significant risk of serious or even life-threatening adverse effects. The boxed warnings address risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems) and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn babies). In addition, when taken with other central nervous system depressants, including alcohol, their use may result in coma or death.

The networks receiving warning letters include:
AnonShop
Eassybuyonline
Instabill ECS-Rx
Medstore.biz
One Stop Pharma
RemedyMart
RxCash.Biz
TramadolHub
XLPharmacy

"The public needs to know that no one is authorized to sell or distribute opioids via the internet in the U.S., with or without a prescription," said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. "Drug dealers and rogue website operators are using the internet to fuel the opioid crisis, heartlessly targeting millions of Americans struggling with opioid use disorder. We will continue to aggressively pursue these criminals and take swift action to protect the American public."

The FDA requested responses from each of the companies within 10 working days. The companies are directed to inform the agency of the specific actions taken to address the agency’s concerns.

Opioid addiction is an immense public health crisis. Addressing it is one of the FDA’s highest priorities and supports the U.S. Department of Health and Human Services’ 5-Point Strategy To Combat the Opioid Crisis. One critical step to addressing this public health emergency is the adoption of a more proactive approach by internet stakeholders to crack down on internet traffic in illicit drugs. Illegal online pharmacies, drug dealers and others are increasingly using the internet to further their illicit distribution of opioids, where their risk of detection and repercussions is significantly reduced.

As part of this effort, Commissioner Gottlieb has invited internet stakeholders and thought-leaders, government entities, academic researchers and advocacy groups to an Online Opioid Summit on June 27 to discuss ways to collaboratively take stronger action in combatting the opioid crisis by reducing the availability of illicit opioids online. Topics to be addressed during the Summit include: research into the ease with which illicit opioids can be purchased online and industry approaches to addressing opioids marketed online, followed by a roundtable discussion to identify gaps and new solutions.

In addition to health risks, illegal online pharmacies can pose other risks to consumers, including credit card fraud, identity theft, and computer viruses. The FDA encourages consumers to report suspected criminal activity to the FDA’s Office of Criminal Investigation. The FDA also provides consumers with information to identify an illegal online pharmacy and information on how to buy medicine safely online through BeSafeRx: Know Your Online Pharmacy.

The FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioids. The agency will also continue to evaluate how opioids currently on the market are used, in both medical and illicit settings, and take regulatory action where needed.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA Recall: Opioid Antidote Naloxone

FDA: Opioid Antidote Naloxone Recalled
TUESDAY, June 5, 2018 (HealthDay News) -- A recall of the opioid overdose antidote Naloxone was announced Monday. The U.S. Food and Drug Administration said the recall was triggered by the possibility of "loose particulate matter on the syringe plunger" that could pose a number of health risks, CNN reported.

Those risks include "local irritation, allergic reactions," and a range of cardiovascular issues, including blood clots, according to the FDA. The agency has not received any reports of patient harm from the recalled Naloxone, made by Hospira.

FDA 
Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

In the event that impacted product is administered to a patient, the patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity. The risk is reduced by the possibility of detection, as the labeling contains a clear statement directing visual inspection of the product for particulate matter and discoloration prior to administration. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

Naloxone Hydrochloride, an opioid antagonist, is indicated for the complete or partial reversal of opioid depression. It is also indicated for the diagnosis of known or suspected opioid overdosage, and as an adjunctive agent for the management of septic shock. It is available as a sterile solution for intravenous (IV), intramuscular (IM), and subcutaneous (SC) administration. Naloxone is supplied in a Carpuject single-use cartridge with a 1 mL fill for use with the Carpuject syringe system.
The NDC, Lot Number, Expiration Date, Strength and Configuration details for Naloxone Hydrochloride Carpuject Injection is indicated below. Product lots were distributed nationwide to wholesalers/distributors/hospitals in the United States, Puerto Rico, and Guam from February 2017 to February 2018.
NDC Number Date Strength Configuration/Count
0409-1782-03
(Single Unit)
0409-1782-69
(Box/Carton)
72680LL 1DEC2018 0.4 mg/mL
1 mL in 2.5mL
10-1 mL Single Use Carpuject&trad;
(Sterile Cartridge Unit with
Luer Lock) per box/carton; 100 boxes/cartons per case (1000)
76510LL 1APR2019 0.4 mg/mL,
1 ml in 2.5 mL

Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Hospira, Inc. has notified wholesalers/ distributors/hospitals to arrange for return of any recalled product.

Distributors or retailers with an existing inventory of the lots, which are being recalled, should stop use and distribution and quarantine immediately. Inform Healthcare Professionals in your organization of this recall. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.
Contact Contact Information Areas of Support
Pfizer Medical
Information
1-800-438-1985, option 3
(8am to 7pm ET Monday through
Friday)
Medical Inquiries
Pfizer Safety 1-800-438-1985, option 1 (24
Hours a day 7 days per week)
To report adver
Events or product
complaints

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Adverse events or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: download form www.fda.gov/MedWatch/getforms.htm or call 1-800-FDA-1088 to request form, then complete and return address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Thursday, May 24, 2018

Hepatitis C Virus Infection Treatments to Be Discontinued:Technivie, Viekira XR and Simeprevir

In Case You Missed It

FDA Website:
https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm?panels=0&#tabs-4

Also discontinued:

Janssen Pharmaceuticals (New 05/23/2018)
Simeprevir Capsules
Status: Discontinuation

Viekira XR

Abbvie (New 05/22/2018)
Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir (Viekira XR) Tablets
Status: Discontinuation
Estimated product availability until January 1, 2019.
The product discontinuation is voluntary and not related to product quality, safety or efficacy.

Technivie
Abbvie (New 05/22/2018)
Ombitasvir; Paritaprevir; Ritonavir (Technivie) Tablets
Status: Discontinuation
Estimated product availability until January 1, 2019. The product discontinuation is voluntary and not related to product quality, safety or efficacy.

Article:
MPR > News > Two Hepatitis C Virus Infection Treatments to Be Discontinued
Da Hee Han, PharmD
May 24, 2018
Two Hepatitis C Virus Infection Treatments to Be Discontinued
Two hepatitis C virus (HCV) combination treatments, Technivie (ombitasvir, paritaprevir, ritonavir) and Viekira XR (dasabuvir sodium, ombitasvir, paritaprevir, ritonavir), have been discontinued by AbbVie, according to the Food and Drug Administration (FDA). The discontinuation is voluntary and is not related to product quality, safety or efficacy.
Read the article: https://www.empr.com/news/technivie-viekira-xr-discontinued-hepatitis-c-virus-treatments/article/768368/

Tuesday, May 22, 2018

FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses

The U.S. Food and Drug Administration has issued warning letters to three marketers and distributors of kratom products – Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California and Revibe, Inc., of Kansas City, Missouri – for illegally selling unapproved kratom-containing drug products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal. The companies also make claims about treating pain, as well as other medical conditions like lowering blood pressure, treating cancer and reducing neuron damage caused by strokes.
“Despite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there’s no reliable scientific proof to support their use,” said FDA Commissioner Scott Gottlieb, M.D. “As we work to combat the opioid epidemic, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction. Far from treating addiction, we’ve determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and puts patients at risk of serious side effects. If people believe that the active ingredients in kratom have drug-like effects that can treat pain or addiction, then the FDA is open to reviewing that data under our new drug approval process. In the meantime, I promised earlier this year that the FDA would step up our actions against unapproved and unsafe products that are being deceptively marketed for the treatment of opioid addiction and withdrawal symptoms. At the same time, we also promised to make the approval process more efficient for novel, safe and effective medical treatments aimed at the treatment of addiction; and to help more people suffering from addiction get access to approved therapies. In fulfilling these commitments, we’ll continue to take enforcement actions against unscrupulous products to protect the public health.”
The FDA continues to warn consumers not to use Mitragyna speciosa, commonly known as kratom, a plant which grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. The FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse and dependence. There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom.
The FDA is actively evaluating all available scientific information on this issue and continues to warn consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine. The FDA encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.
The companies receiving warning letters use websites where they take orders for kratom products or they use social media to make unproven claims about the ability of their kratom drug products to cure, treat, or prevent a disease, which is against the law. Examples of claims being made by these companies include:
  • “Along with helping drug addiction, the health benefits of kratom leaves include their ability to lower blood pressure, relieve pain, boost metabolism, increase sexual energy, improve the immune system, prevent diabetes, ease anxiety, eliminate stress, and induce healthy sleep.”
  • “The mood elevation qualities of kratom reduces opiate withdrawal effects.”
  • “Kratom, like any other pain killer, relieves temporary or even chronic pain.”
  • “This plant can relieve headaches, vascular pain, arthritic pain, muscle pain among others.”
  • “Kratom can be used as a remedy for stroke-related ailments and condition as it is a powerful antioxidant that works to reduce neuron damage.”
  • “It can . . . help in lowering blood pressure.”
  • “Kratom is also said to have elements that control blood sugar level in the body for diabetic patients.”
  • “It is said, that kratom is very effective against cancer.”
Health fraud scams like these can pose serious health risks. These products have not been demonstrated to be safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal and treat other serious medical conditions is a violation of the Federal Food, Drug, and Cosmetic Act.
Reducing the number of Americans who are addicted to opioids and cutting the rate of new addiction is one of the FDA’s highest priorities. This work includes promoting more widespread innovation and access to opioid addiction treatments for the more than 2 million of Americans with an opioid use disorder. The FDA is taking new steps to make safe and effective medication assisted treatments (MAT) available to those who suffer from opioid use disorder and to reduce the stigma that is sometimes associated with use of these therapies. Using products with unsubstantiated claims may prevent those addicted to opioids from seeking treatments that have been demonstrated to be safe and effective. Reliance on products with unsubstantiated claims may delay their path to recovery and put them at greater risk of addiction, overdose and death. In fact, patients receiving FDA-approved medication-assisted treatment cut their risk of death in half, according to the Substance Abuse and Mental Health Services Administration.
The warning letters included more than 65 kratom products. Some of these products include:
Front Range Kratom:
  • “Maeng Da Red Vein Powder”
  • “Maeng Da White Vein Capsules”
  • “Liquid Kratom Red Maeng Da Enhanced Pain Formulation”
  • “Bali White Vein Kratom Powder”
  • “Bali Green Vein Powder”
  • “Maeng Da White Energizing Formula”
Kratom Spot:
  • “Red Thai Kratom Powder”
  • “Indo White Vein Kratom Powder”
  • “Borneo White Vein Kratom Powder”
  • “Green Malay Kratom Powder”
  • “Super Green Indo Kratom Capsules”
  • “Ultra Enhanced Malay Kratom Powder”
  • “Kratom Extract 8x Kratom Powder”
Revibe:
  • “50x Black Diamond Extract”
  • “Green Horn Kratom”
  • “Green Indo”
  • “Green Sumatra,” “Lucky 7”
  • “Red Borneo”
  • “Super Elephant”
  • “White Sumatra”
  • “Yellow Vietnam Kratom”
The FDA requested responses from each of the companies within 15 working days. The companies are directed to inform the agency of the specific actions taken to address each of the agency’s concerns. The warning letters also state that failure to correct violations may result in law enforcement action such as seizure or injunction.
Previous FDA testing also confirmed salmonella contamination in kratom products distributed by Revibe. On March 26, 2018, the FDA contacted Revibe regarding a recall of all Revibe kratom containing products that may be contaminated with salmonella. On April 3, 2018, the agency oversaw the destruction of products at Revibe’s facility, but, as of April 19, 2018, the company has not provided the FDA information to confirm that they have recalled the products it distributed. The FDA reminds consumers of the risks and urges them not to use these or any other kratom products.
Health care professionals and consumers are encouraged to report any adverse events related to these products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608447.htm

Thursday, May 3, 2018

FDA Advises Consumers & Retailers to Avoid Potentially Contaminated Raw Oysters from Canada

By News Desk | May 1, 2018 
A Canadian outbreak of norovirus traced to raw oysters is now on the U.S. radar as federal and state officials report they are investigating a multistate outbreak in this country.

More than 170 people across three Canadian provinces, Alberta, British Columbia and Ontario, had been infected by the highly contagious virus as of the most recent report from the Public Health Agency of Canada. The health agency and the Canadian Food Inspection Agency have been working on the outbreak investigation since early April. Monday evening the U.S. Food and Drug Administration issued its own outbreak investigation notice.... 

Raw oysters can cause illness in anyone, but they are particularly dangerous for young children, older adults, pregnant women and people with compromised immune systems. Oysters and other food contaminated with noroviruses usually looks, smells and tastes normal.


FDA Press Release: FDA Advises Consumers & Retailers to Avoid Potentially Contaminated Raw Oysters from Canada
May 2, 2018
What is the Problem and What is being Done About It?
The U.S. Food and Drug Administration is working with federal, state, and local officials regarding a norovirus outbreak linked to raw oysters from British Columbia, Canada. The FDA has confirmed that potentially contaminated raw oysters harvested in the south and central parts of Baynes Sound, British Columbia, Canada, were distributed to AK, CA, IL, MA, NY, and WA. It is possible that additional states received these oysters either directly from Canada or through further distribution within the U.S.

FDA and the states are conducting a traceforward investigation to determine where the raw oysters were distributed and ensure they’re removed from the food supply. Retailers should not serve raw oysters harvested from the following harvest locations (or landfiles) within Baynes Sound: #1402060, #1411206, #1400483, and #278757.

Oysters can cause food-related illness if eaten raw, particularly in people with compromised immune systems. Food contaminated with noroviruses may look, smell, and taste normal.

What are the Symptoms of Norovirus Infection
Most people infected with Norovirus develop diarrhea, vomiting, nausea, and stomach pain. Diarrhea tends to be watery and non-bloody. Diarrhea is more common in adults and vomiting is more common in children.

How Soon After Exposure do Symptoms Appear?
Most people infected with Norovirus develop diarrhea, fever, and abdominal cramps 12 to 48 hours after infection.

Who is at Risk?
Anyone who consumes raw shellfish is at risk of contracting Norovirus. Children younger than five, the elderly, and those people with weakened immune systems are more likely to have severe infections.

What Do Restaurants and Retailers Need To Do?
Restaurants and retailers should not sell the potentially affected raw oysters. Restaurants and retailers should dispose of any products by throwing them in the garbage or returning to their distributor for destruction.

Restaurants and retailers should also be aware that the oysters may be a source of pathogens and should control the potential for cross–contamination of food processing equipment and the food processing environment. They should follow the steps below:

-Wash hands with warm water and soap following the cleaning and sanitation process.
-Retailers, restaurants, and other food service operators who have processed and packaged any potentially contaminated products need to be concerned about cross contamination of cutting surfaces and utensils through contact with the potentially contaminated products.
-Retailers that have sold bulk product should clean and sanitize the containers used to hold the product.
-Regular frequent cleaning and sanitizing of food contact surfaces and utensils used in food preparation may help to minimize the likelihood of cross–contamination.

What Do Consumers Need To Do?
People should not eat any raw oysters from the locations listed above. If they have any of the listed products, they should throw them in the garbage.

People who think they might have become ill from eating possibly contaminated raw oysters should talk to their health care providers.

Consumers should always practice safe food handling and preparation measures. Wash hands, utensils, and surfaces with hot, soapy water before and after handling food.

For food preparation surfaces and food cutting utensils that may have come in contact with the potentially contaminated oysters, it is very important that the consumers thoroughly clean these areas and items.

Who Should be Contacted?
People who think they might have become ill from eating possibly contaminated oysters should talk to their health care providers. Contact your healthcare provider if you have diarrhea that lasts for more than 3 days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.

The FDA encourages consumers with questions about food safety to call 1-888-SAFEFOOD or consult the fda.gov website: http://www.fda.gov.

Additional Information
CDC Norovirus
Raw Oyster Myths
Canadian Public Health Notice - Norovirus

Tuesday, April 3, 2018

FDA orders mandatory recall for kratom products - Triangle Pharmanaturals refused to cooperate

FDA News Release
FDA orders mandatory recall for kratom products due to risk of salmonella


Triangle Pharmanaturals refused to cooperate with FDA despite repeated attempts to encourage voluntary recall

The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.

Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.

The FDA is advising consumers to discard the products that are part of the mandatory recall, which include, but are not limited to: Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red. The FDA understands that Triangle Pharmanaturals may manufacture, process, pack and/or hold additional brands of food products containing powdered kratom, including powder and encapsulated powder forms.

“This action is based on the imminent health risk posed by the contamination of this product with salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions,” said FDA Commissioner Scott Gottlieb, M.D. “We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately. But the action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen. Our first approach is to encourage voluntary compliance, but when we have a company like this one, which refuses to cooperate, is violating the law and is endangering consumers, we will pursue all avenues of enforcement under our authority.”

Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Importantly, the FDA advises consumers to avoid kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, in any form and from any manufacturer. The agency also has received concerning reports about the safety of kratom, including deaths associated with its use. There is strong evidence that kratom affects the same opioid brain receptors as morphine and appears to have properties that expose people who consume kratom to the risks of addiction, abuse and dependence. The agency also remains concerned about the use of kratom as an alternative to FDA-approved pain medications or to treat opioid withdrawal symptoms, as neither kratom nor its compounds have been proven safe and effective for any use and should not be used to treat any medical conditions.

In this instance, two samples of kratom products manufactured by Triangle Pharmanaturals of Las Vegas, Nevada, sold through the retail location Torched Illusions in Tigard, Oregon and collected by the Oregon Public Health Division, tested positive for salmonella, as did four additional samples of various types of kratom product associated with the firm collected by the FDA. Adding to the concerns, in the course of investigating a multi-state outbreak of salmonella infections linked to kratom products in conjunction with local officials, FDA investigators were denied access to the company’s records relating to potentially affected products and Triangle employees refused attempts to discuss the agency’s findings.

Under the FDA Food Safety Modernization Act, the FDA has the authority to order the recall of certain food products when the FDA determines that there is a reasonable probability that the article of food is adulterated or in violation of certain allergen labeling requirements and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.

On March 30, the FDA issued Triangle Pharmanaturals a Notification of Opportunity to Initiate a Voluntary Recall, a formal request that advised the company that the agency could order the firm to cease distribution and notify applicable parties within 24 hours if the company did not conduct a voluntary recall. However, Triangle Pharmanaturals did not comply with the request. On March 31, the FDA then ordered the company to cease distribution of the products and the company was provided with an opportunity to request an informal hearing. The company did not respond within the timeframe specified, therefore waiving its opportunity for an informal hearing, and the agency ultimately issued the mandatory recall order in the interest of public safety. This is the third time the FDA has started the process of using its mandatory recall authority, but the first time the agency has gotten to the step of ordering a mandatory recall because a company has opted not to voluntarily recall after the FDA’s notification of an opportunity to initiate a voluntary recall.

Numerous brands of kratom-containing products have been linked to a multi-state outbreak of salmonellosis from multiple strains of salmonella. The FDA continues to advise consumers to avoid kratom and kratom-containing products and discard any in their possession. All salmonella bacteria can cause the foodborne illness salmonellosis, although the strains found in Triangle Pharmanaturals’ products are not currently linked to the outbreak. The FDA is working with the U.S. Centers for Disease Control and Prevention to continue to investigate the ongoing outbreak. Most people infected with salmonella develop diarrhea, fever and abdominal cramps 12 to 72 hours after infection. The illness usually lasts 4 to 7 days, and most people recover without treatment. However, in the current salmonellosis outbreak associated with kratom products, unusually high rates of individuals have been hospitalized for their illness.

If consumers have one or more of these products in their homes, they should discard them immediately. As a precaution, kratom no longer stored in its original packaging should be discarded and the containers used to store it should be thoroughly washed and sanitized. In order to prevent cross-contamination, consumers should wash their hands, work surfaces and utensils thoroughly after contact with these products, and not prepare any food in the area at the same time.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm603517.htm

Wednesday, November 22, 2017

FDA issues guidance on developing generic abuse-deterrent opioids

FDA issues guidance on developing generic abuse-deterrent opioids
Today, the FDA revealed its newest action to reduce the span of the opioid abuse and addiction crisis — guidance to assist the development of generic versions of approved opioids formulated to deter abuse. The FDA plans to decrease unnecessary exposure to opioids by promoting the development of improved alternatives that are harder to manipulate and abuse for patients who need pain medications. It is critical to also encourage the use of opioids with abuse-deterrent formulations over opioids without such properties until a new nonopioid drug for pain management is available, according to Scott Gottlieb, MD, commissioner of the FDA.
Commentary available online @ Healio

FDA Press Release
Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse
As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we’re focused on taking actions that reduce the scope of new addiction by decreasing unnecessary exposure to opioids. At the same time, we also must take steps to help those with acute and chronic pain who need access to medicines, including opioids, get access to improved alternatives. Until we’re able to find new non-opioid forms of pain management for those who need treatment for pain, it’s critical that we also continue to promote the development of opioids that are harder to manipulate and abuse, and take steps to encourage their use over opioids that don’t offer any form of abuse deterrence.

Opioids with abuse-deterrent formulations (ADFs) are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding. To date, the U.S. Food and Drug Administration has approved 10 opioid drugs with these properties. But their uptake has been slow among doctors who are treating patients in pain. The reason for their more limited use is likely multifold. We know there can be a learning curve that comes with new technologies. Some prescribers may not be aware of the existence of these drugs, or may be uncertain of when to prescribe the abuse-deterrent versions. But we also know a significant barrier to use can be price. Because these new formulations are currently only available as brand-name products, they’re inherently more expensive than the numerous non-abuse deterrent formulations that are also available in generic formulations.

Transitioning from the current market, dominated by conventional opioids, to one in which most opioids have abuse-deterrent properties, holds significant promise for a meaningful public health benefit. But to transition this market more quickly to the ADFs, and consider permanently withdrawing the older formulations that lack abuse-deterrent features in the event these products were judged to be less safe ‒ there are a number of factors we must consider. One of the factors that the FDA would consider relates to generic access. We must have the potential to improve access to the newer formulations, for appropriately selected and monitored patients, through the introduction of generic competitors.

In order to support this transition and encourage advancements in this area, today the FDA issued a final guidance to assist industry in their development of generic versions of approved ADF opioids. This guidance includes new recommendations about the type of studies companies should conduct to demonstrate that the generic drug is no less abuse-deterrent than its brand-name counterpart. We’re also taking additional steps beyond the new guidance to help developers of generic ADFs navigate the regulatory path to market as quickly as possible and make the review process more efficient and predictable. For example, we’re developing appropriate, improved testing methodologies for evaluating complex features like abuse deterrence for both brand name (innovator) and generic opioid drug products. In addition, we’re also taking a flexible, adaptive approach to the evaluation and labeling of ADF opioids.

These efforts also include the development of new tools for expediting the generic development of complex products. The same features that make drugs hard to manipulate and abuse also make these formulations more complex, and therefore harder to develop generic versions of. To provide a more efficient pathway for the generic entry of these and other complex formulations, the FDA is advancing new review policies. For example, the new guidance will now assist generic drug developers who meet with the agency to discuss scientific and regulatory issues before submitting their applications. These meetings will enable the FDA to clarify the agency’s expectations early in the development process with the goal of reducing the time it takes to obtain approval. We’ll be taking additional steps to facilitate the efficient entry of complex generic drugs in the near future.

Together, all of these efforts are aimed at creating a more robust path for applicants who plan to develop and seek approval of generic ADF opioids. Our goal is, when the use of any opioid drug product is appropriate, to make prescribing of these new formulations more commonplace. But let us be clear on one point. While these innovative formulations are designed to make it harder for people to manipulate the opioid drug so they can’t be abused, it’s important that prescribers and patients understand that these drugs are not “abuse-proof,” and they do not prevent addiction, overdose, or death. To address these issues, among other steps, we’re currently conducting a study to evaluate whether the nomenclature we use to describe these drugs, by labeling them “abuse deterrent,” is accurately conveying their benefits.

We also recognize that the science of abuse deterrence is relatively new. Both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving. That’s why we’re also focusing our efforts on determining how effective the current abuse-deterrent products are in the real-world setting and better understanding the attitudes and beliefs of health care professionals and those who are prescribed these products.

Further, all of these steps shouldn’t be mistaken as an effort that will encourage more opioid use. Our goal is to decrease the rate of new addiction, and thus any unnecessary legitimate and especially illicit use of opioids. Rather, this is an effort designed to encourage the shift – only when opioids are clinically appropriate ‒ from existing, easily abused products to those that are harder to manipulate.

This final guidance is one piece of the FDA’s ongoing work aimed at finding solutions to combat the opioid crisis. This effort must include treatments for those who are already addicted. That’s why we are also focusing new efforts on the development and promotion of medication-assisted treatments for addiction. As we balance the need to effectively treat pain with the public health emergency related to opioid addiction, we must find creative ways to prevent new cases of abuse and addiction.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Wednesday, September 27, 2017

FDA conducts global operation to protect consumers from rogue online pharmacies


FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online
September 25, 2017
Illegally marketed opioids are among the products targeted, along with the websites that sell them, during international Operation Pangea X

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers.

These actions were part of a major global operation that the FDA participated in to target illegal drugs being marketed online, and shipped and distributed through the postal system, directly to American consumers. Among other actions, the FDA also issued warning letters to the operators of a majority of the illegal websites that were targeted in the operation and worked with internet registrars to confiscate certain websites. Patients who buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being passed off as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe.

“These rogue online pharmacies are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including counterfeit medicines and controlled substances. Consumers go to these websites believing that they are buying safe and effective medications, but they are being deceived and put at risk by individuals who put financial gains above patient safety,” said FDA Commissioner Scott Gottlieb, M.D. “The ease with which consumers can purchase opioid products online is especially concerning to me, given the immense public health crisis of addiction facing our country. Some of the websites sold unapproved versions of multiple prescription opioids directly to U.S. consumers. This easy and illegal availability of these controlled substances fuels the misuse and abuse of opioids. As part of a broader effort to target this illegal activity, in addition to the operation that we are announcing today, the FDA is also working on a comprehensive Enforcement Operations Work Plan that’s focused on combating the sale of foreign unapproved drugs to U.S. consumers and aimed at increasing the scope of our operations related to these risks.”

This effort was part of Operation Pangea X, as part of the 10th annual International Internet Week of Action (IIWA), a global cooperative effort led by Interpol, to combat the unlawful sale and distribution of illegal and potentially counterfeit or substandard medical products on the internet. The IIWA ran from Sept. 12 to Sept. 19, 2017. The goal of Operation Pangea X was to identify the makers and distributors of illegal prescription drug products and to remove these products from the supply chain. Commissioner Gottlieb joined efforts to kick off the operation with a visit he made to the International Mail Facility (IMF) in New York on Aug. 25, 2017.

During Operation Pangea X, the FDA sent 13 warning letters to the operators of 401 websites. The FDA also seized nearly 100 website domain names, such as buyhydrocodoneonline.com, canadian-pharmacy24x7.com and buyklonopin.com. FDA inspectors, in collaboration with other federal agencies, screened packages suspected of containing illegal drug products at IMFs in Chicago, Miami and New York during the IIWA. These screenings resulted in nearly 500 parcels being detained for appropriate FDA compliance follow up. Parcels found in violation of the Federal Food, Drug, and Cosmetic Act will be refused entry into the country.

“The FDA is proud to partner with our international counterparts on this important operation,” Commissioner Gottlieb said. “However, our work to fight illegal online pharmacies is not over. In addition to the multifaceted work plan we will soon unveil, we’ve recently tripled the staff we have in the IMFs to improve our ability to inspect packages that are suspected of containing illegal drugs, and we have doubled the number of cybercrime and port of entry special agents for the Office of Criminal Investigations. These efforts are part of a much broader work plan that the FDA is developing aimed at beefing up our efforts to interdict illegal drugs.”

In addition to health risks, illegal online pharmacies can pose other risks to consumers, including credit card fraud, identity theft and computer viruses. The FDA encourages consumers to report suspected criminal activity to the FDA’s Office of Criminal Investigation.

The FDA also provides consumers with information to identify an illegal online pharmacy and information on how to buy medicine safely online through BeSafeRx: Know Your Online Pharmacy.

The IIWA is a collaborative effort between the FDA, the U.S. Attorney’s Office for the District of Colorado, the U.S. Department of Homeland Security, National Intellectual Property Rights Coordination Center, Interpol, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, the European Heads of Medicines Agencies Working Group of Enforcement Officers, the U.S. Drug Enforcement Administration, the pharmaceutical industry and national health and law enforcement agencies from 115 participating countries.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Sunday, September 24, 2017

Bristol-Myers Squibb’s Opdivo® (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib

Bristol-Myers Squibb’s Opdivo® (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib

Opdivo is the first and only Immuno-Oncology agent to receive this FDA approval; this accelerated approval is based on tumor response rate and durability of response in these patients
  • The CheckMate -040 pivotal study evaluated Opdivo in patients with and without active Hepatitis B or C infection, and across PD-L1 expression levels 1,2
  • HCC is the most common type of liver cancer and incidence rates are increasing 3,4

  • PRINCETON, NJ, USA I September 22, 2017 I Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Approval for this indication has been granted under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.1 In the CheckMate -040 trial, 14.3%* (95% CI: 9.2-20.8; 22/154) of patients responded to treatment with Opdivo. The percentage of patients with a complete response was 1.9% (3/154) and the percentage of patients with a partial response was 12.3% (19/154).1 Among responders (n=22), responses ranged from 3.2 to 38.2+ months; 91% of those patients had responses of six months or longer and 55% had responses of 12 months or longer.1

    Opdivo is associated with the following Warnings and Precautions including: immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion reactions; and embryo-fetal toxicity.1 Please see the Important Safety Information section below.

    “We are proud to bring the potential for clinically meaningful responses with Immuno-Oncology therapy to these advanced-stage HCC patients, who have had limited treatment options for years,” said Chris Boerner, president, U.S. Commercial, Bristol-Myers Squibb. “Today’s approval marks an important step toward our mission of delivering transformational medicines to treat conditions with a high unmet need.”

    The burden of liver cancer in the U.S. is significant and is expected to increase in the decades to come.5,6 A recently-released American Cancer Society (ACS) report published in CA: A Cancer Journal for Clinicians notes that death rates for liver cancer are increasing at a faster pace than any other cancer, doubling since the mid-1980s.5

    “Unfortunately, the majority of HCC patients are diagnosed with advanced-stage disease and are not candidates for potentially curative surgical interventions,” said Adrian M. Di Bisceglie, M.D., co-director, Saint Louis University Liver Center, Chief of Hepatology. “More options are needed for advanced-stage HCC patients who have failed prior systemic therapy.”
    Hepatocellular carcinoma is often diagnosed in the advanced-stage where treatment options are limited and there is a high unmet need for patients who are intolerant to or who have progressed on sorafenib therapy.5,7,8

    “In recent years, there has been growing interest in leveraging immuno-oncology knowledge and discoveries to add to the treatment options available for patients with advanced-stage liver cancer,” said Anthony B. El-Khoueiry, M.D., lead investigator and associate professor of clinical medicine and phase I program director at the Keck School of Medicine of University of Southern California (USC) and the USC Norris Comprehensive Cancer Center. “The approval of Opdivo provides us with an encouraging approach and a new treatment option for appropriate patients with HCC following prior systemic therapy.

    Approval Based on Notable Overall Response Rate and Duration of Response
    CheckMate -040 included a Phase 1/2, open-label, multicenter study evaluating Opdivo in patients with HCC who progressed on or were intolerant to sorafenib.1,9 In this study, 154 patients received Opdivo 3 mg/kg administered intravenously every two weeks. The recommended dose is 240 milligrams administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity.1 Efficacy outcome measures included confirmed overall response rate (as assessed by blinded independent central review using RECIST v1.1 and modified RECIST for HCC) and duration of response.1 The median age of patients participating in the study was 63 (range: 19-81), all patients had received prior sorafenib therapy and 19% of patients had received two or more prior systemic therapies.1 Patients were enrolled regardless of PD-L1 expression level and whether or not they were infected with active Hepatitis B virus (HBV) or active Hepatitis C virus (HCV).1,2 Data from CheckMate -040 were presented at the American Society of Clinical Oncology 2017 Annual Meeting in June.

    In the CheckMate -040 trial, 14.3%* (95% CI: 9.2-20.8; 22/154) of patients responded to treatment with Opdivo. The percentage of patients with a complete response was 1.9% (3/154) and the percentage of patients with a partial response was 12.3% (19/154). Among responders (n=22), responses ranged from 3.2 to 38.2+ months; 91% of those patients had responses of six months or longer and 55% had responses of 12 months or longer.1 The median time to response was 2.8 months (range: 1.2-7.0).2 The overall response rate based on modified RECIST was 18.2% (95% CI: 12.4-25.2; 28/154). Complete response rate was 3.2% (5/154); partial response rate was 14.9% (23/154).1 Responses were observed across PD-L1 expression levels.2
    “I advocate for others because I know firsthand the terrible toll cancers of the liver take on a patient and their loved ones. In my opinion, HCC is an example of a cancer where awareness is out of sync with the impact of the disease,” said Suzanne Lindley, Co-Founder, Yes! Beat Liver Tumors. “Today’s approval shines a light of awareness and hope on a disease with a high unmet medical need.”

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