Chronic hep C treatment in HIV-infected patients with compensated liver cirrhosis
Sustained virological response was associated with HCV genotypes 2–3
Journal of Viral Hepatitis
The most recent issue of the Journal of Viral Hepatitis investigates treatment of chronic hepatitis C in HIV-HCV coinfected patients with compensated liver cirrhosis.
The greatest benefit of hepatitis C virus (HCV) therapy is seen in cirrhotics attaining sustained virological response.
However, concerns about toxicity and poorer responses often discourage treatment of cirrhotics.
This may be particularly relevant in HIV–HCV-coinfected patients, in whom progression of liver fibrosis is faster and treatment responses lower.
Dr Luz Martin-Carbonero and colleagues from Spain performed a retrospective analysis of HIV–HCV-coinfected patients who had received peginterferon–ribavirin therapy at their institution.
Individuals naïve for interferon in whom liver fibrosis had been assessed using elastometry within the year before being treated were chosen.
Response rates and toxicities were compared in cirrhotics and noncirrhotics.
Patients with previous liver decompensation were excluded.
Overall, the team found that 41 cirrhotics and 190 noncirrhotics entered the study.
Groups were similar in age, gender, HCV genotypes and baseline serum HCV-RNA.
The research team observed that sustained virological response occurred at similar rates in cirrhotic and noncirrhotics, either considered by intention-to-treat or as treated.
The researchers found that sustained virological response was associated with HCV genotypes 2–3 and lower serum HCV-RNA but not with cirrhosis.
The team noted that treatment discontinuations because of adverse events tended to be more common in cirrhotics than in noncirrhotics, but only severe thrombocytopenia was more frequent in cirrhotics than in non-cirrhotics.
Dr Martin-Carbonero's team concluded, "Response to peginterferon–ribavirin therapy is similar in HIV–HCV coinfected patients with and without liver cirrhosis."
"Therefore, treatment must be encouraged in all compensated cirrhotic patients, although closer monitoring and management of side effects, mainly thrombocytopenia, may be warranted."
J Viral Hep 2011: 18(8): 542–548
29 July 2011
Friday, July 29, 2011
Thursday, July 28, 2011
New Zealand- Hepatitis war can be won - expert
Hepatitis war can be won - expert
STACEY KIRK
Last updated 12:00 28/07/2011
Hepatitis can be "obliterated in a generation" if intravenous drug users stick to clean needles and hepatitis B vaccinations reach almost 100 per cent of the population, a MidCentral Health gastroenterologist says.
"The tragic thing is it could in fact be eradicated quite quickly," Dr Andrew Herbert said.
Today is World Hepatitis Day.
It is expected the number of New Zealanders who will die because of chronic viral hepatitis will treble during the next 20 years.
Hepatitis causes inflammation of the liver and can lead to more serious illnesses such as liver failure and liver cancer. Often, people in the early stages of chronic hepatitis B and C have no symptoms, and both strains can be successfully treated to halt the disease.
But low testing and diagnosis rates mean only 10 per cent of all New Zealanders with viral hepatitis have been diagnosed and less than 5 per cent have been cured.
Dr Herbert said it was estimated about 1 per cent of New Zealand's population had either hepatitis B or C. He said he was treating 15 people, almost exclusively for hepatitis C, and another 28 people in the MidCentral district were waiting to start treatment.
"There are undoubtedly a lot more out there, though, who don't know they have it," he said.
The Hepatitis Foundation of New Zealand said in 90 per cent of hepatitis C cases, the cause was recreational drug injection.
Associate professor and chief hepatologist at the New Zealand Liver Transplant Unit at Auckland City Hospital Ed Gane said viral hepatitis was thought to be responsible for more than 90 per cent of liver cancer cases in New Zealand.
"We need to dramatically increase the number of New Zealanders who receive anti-viral treatment ... to mitigate this health and financial burden."
STACEY KIRK
Last updated 12:00 28/07/2011
Hepatitis can be "obliterated in a generation" if intravenous drug users stick to clean needles and hepatitis B vaccinations reach almost 100 per cent of the population, a MidCentral Health gastroenterologist says.
"The tragic thing is it could in fact be eradicated quite quickly," Dr Andrew Herbert said.
Today is World Hepatitis Day.
It is expected the number of New Zealanders who will die because of chronic viral hepatitis will treble during the next 20 years.
Hepatitis causes inflammation of the liver and can lead to more serious illnesses such as liver failure and liver cancer. Often, people in the early stages of chronic hepatitis B and C have no symptoms, and both strains can be successfully treated to halt the disease.
But low testing and diagnosis rates mean only 10 per cent of all New Zealanders with viral hepatitis have been diagnosed and less than 5 per cent have been cured.
Dr Herbert said it was estimated about 1 per cent of New Zealand's population had either hepatitis B or C. He said he was treating 15 people, almost exclusively for hepatitis C, and another 28 people in the MidCentral district were waiting to start treatment.
"There are undoubtedly a lot more out there, though, who don't know they have it," he said.
The Hepatitis Foundation of New Zealand said in 90 per cent of hepatitis C cases, the cause was recreational drug injection.
Associate professor and chief hepatologist at the New Zealand Liver Transplant Unit at Auckland City Hospital Ed Gane said viral hepatitis was thought to be responsible for more than 90 per cent of liver cancer cases in New Zealand.
"We need to dramatically increase the number of New Zealanders who receive anti-viral treatment ... to mitigate this health and financial burden."
Video;HIV and Children Study
Posted by: Symposier
Uploaded and shared in Youtube by: UniversityHospitals —
Dr. Grace McComsey is the Division Chief of Pediatric Infectious Diseases at UH Rainbow Babies & Children's Hospital.
For more information on our Division of Pediatric Infectious Diseases, visit http://ow.ly/5KZP5 .
Best tool in fight against hepatitis is knowledge
Best tool in fight against hepatitis is knowledge
By TONY MUMA, FOR THE SUDBURY STAR
According to Camille Lavoie, an Access AIDS Network nurse, the World Health Organization defines an epidemic as something that affects more than 1% of the population.
That's not a good thing for Sudbury, as the city carries a 1.02% hepatitis infection rate.
For the city's drug using population, the news is worse.
"Seventy percent of Sudbury's drug-using population carries hepatitis B or C," Lavoie said, adding that much of the disease diagnoses happen through the Access AIDS Network.
"That 70% of Sudbury's drug-using population can also carry HIV."
Lavoie said Sudbury's aboriginal population is at risk to hepatitis infection, as well.
Since 2007, July 28 has been recognized worldwide as World Hepatitis Day, Lavoie said.
Today, 500 million people in the world have hepatitis B or C, with 600,000 to one million infected in Canada.
Education and awareness are the artillery in the battle against hepatitis, so the Access AIDS Network partnered with the Sudbury Public Health Unit, Sudbury Action Centre for Youth, The Point -- Needle Exchange and Twisted Doll Tattoos and Piercings to educate people at the Rainbow Centre's main court.
"The point we're trying to get across is to know hepatitis and confront it," Lavoie said.
"People need to know it's a transmittable disease, especially through drug use like injecting, snorting and sharing a crack pipe."
There were activities at the event, strategically placed in the Rainbow Centre in the downtown, which Lavoie called "the epicentre of Sudbury's most at-risk."
Hepatitis trivia games with prizes, face-painting for kids and information booths were set up with free memorabilia giveaways.
The vaccine for hepatitis has been around for almost 30 years and most of Ontario's at-risk are immunized through high school vaccination programs.
Hepatits B can result in liver cancer and failure, Lavoie said, "so you'll go from having an inflamed liver to sudden liver failure."
"Hepatitis C is a bit more long term, it can work on your liver for 30 years. It's usually treatable."
Lavoie reiterated that the best weapon against hepatitis is knowledge.
"The more you know about hepatitis, the more ready you are to fight it."
Hepatitis C-Vertex/INCIVEK Development Progress Updates
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the quarter ended June 30, 2011 and provided an update on the launch of INCIVEKTM (telaprevir) tablets and its development programs.
“Upon approval in May, Vertex was prepared to immediately make INCIVEK available to people with hepatitis C, and the first person was able to begin treatment just three days after approval. We are very pleased with the launch of this important new medicine.”
The company reported approximately $75 million in net product revenues for INCIVEK in the second quarter. Vertex ended the quarter with a cash position of approximately $593 million and expects to become a cash flow and earnings positive company for 2012. The company also today provided several updates to its development-stage programs in hepatitis C, cystic fibrosis (CF), rheumatoid arthritis and influenza. The company noted that it plans to submit its New Drug Application (NDA) in the United States and Marketing Authorization Application (MAA) in the European Union for VX-770 in October 2011 for people with CF who have a specific mutation known as G551D. Vertex is also preparing to initiate multiple additional studies in CF, including two studies to evaluate combinations of Vertex’s investigational CF medicines planned for later this year and three additional studies of VX-770 planned to begin in the first half of 2012.
“The second quarter of 2011 was marked by several defining events for our company, including the approval and launch of INCIVEK for the treatment of hepatitis C and the completion of the Phase 3 program for VX-770 in cystic fibrosis,” said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex.
“Upon approval in May, Vertex was prepared to immediately make INCIVEK available to people with hepatitis C, and the first person was able to begin treatment just three days after approval. We are very pleased with the launch of this important new medicine.”
Recent Clinical Development Progress
Hepatitis C:
Positive Opinion Issued by European Committee for Medicinal Products for Human Use (CHMP) for Telaprevir
Vertex’s collaborator, Tibotec Virco-Virology BVBA, one of the Janssen Pharmaceutical companies of Johnson & Johnson, announced last week that the CHMP adopted a positive opinion to recommend the approval of telaprevir in Europe. The positive opinion will be considered by the European Commission, which has authority to approve new medicines for use throughout the European Union.
Vertex expects that Tibotec will receive a response from the European Commission on their application for approval in the third quarter of 2011. Following marketing authorization approvals, telaprevir will be marketed in the European Union and certain other global territories under the brand name INCIVOTM by the Janssen companies.
Enrollment Complete in Phase 3b Study of Twice-daily Dosing of INCIVEK
Patient enrollment is complete in a Phase 3b clinical trial to evaluate twice-daily dosing of INCIVEK (1,125 mg; BID) compared to three-times-daily dosing of INCIVEK (750 mg; q8h) in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) for people with chronic genotype 1 hepatitis C. Sustained viral response (SVR, or viral cure) data from OPTIMIZE are expected as early as the second half of 2012, which could support the submission of a supplemental NDA for twice-daily dosing of INCIVEK by the end of 2012.
Interim Results from Phase 2 Combination Study of INCIVEK and VX-222
In a separate press release issued earlier this week, Vertex announced results from an interim analysis of the two, four-drug (quad) arms of an ongoing Phase 2 clinical trial evaluating multiple 12- and 24-week response-guided regimens of Vertex’s lead investigational hepatitis C virus polymerase inhibitor, VX-222, dosed in combination with INCIVEK.
The study currently includes four treatment arms. Two of the arms are fully enrolled and are evaluating four-drug combinations of VX-222 (400 mg or 100 mg; BID), INCIVEK (1,125 mg; BID), pegylated-interferon and ribavirin. The third and fourth arms are three-drug treatment arms that are evaluating a twice-daily, all-oral, interferon-free regimen of INCIVEK (1,125 mg), VX-222 (400 mg) and ribavirin in people with genotype 1a or 1b chronic hepatitis C. Vertex expects to complete enrollment in the all-oral arms in the third quarter of 2011.
Data from this study will be submitted for presentation at a medical meeting later this year.
Phase 2 Study of INCIVEK Combination Treatment Evaluating 12-week Regimens on Track to Begin in the Third Quarter
IL28B gene
Vertex plans to begin a Phase 2 trial in the third quarter that will evaluate a treatment regimen of INCIVEK dosed in combination with pegylated-interferon and ribavirin for people who have a specific genetic marker, known as CC, near the IL28B gene. All people in the study will receive 12 total weeks of treatment. The trial is expected to include approximately 400 people with genotype 1 chronic hepatitis C who have not previously been treated. Data from this trial are expected in 2012.
Continue reading..............
UPDATE 2-New Vertex hepatitis drug shines out of gate
* EPS loss of $0.85 vs Street view loss $0.96
* Incivek sales $74.5 million in first five weeks
* Shares rise 3.9 percent (Adds analyst comment, expectations, share move)
By Bill Berkrot
NEW YORK, July 28 (Reuters) - Vertex Pharmaceuticals Inc's (VRTX.O) new hepatitis C drug stormed out of the gate, posting sales of nearly $75 million in its first five weeks on the market, and the company's shares rose nearly 4 percent.
Incivek, which is likely to become part of the standard of care for hepatitis C and widely expected to become a multibillion-dollar seller, won U.S. approval in May.
"This is a really, really impressive revenue ramp," Sanford Bernstein analyst Geoffrey Porges said. "You run this trend forward and you get to $200 million in revenue in the third quarter."
Investors who have been shorting the Vertex stock with a view that Incivek was bound to fall shy of sky-high expectations "are going to be in a world of pain tomorrow," Porges predicted.
The company reported a narrower and smaller-than-expected second-quarter net loss as the high cost of launching its first commercial product and higher research and development expenses were offset by strong early demand for the new medicine.
The biotechnology company on Thursday posted a net loss of $174.1 million, or 85 cents per share, compared with a loss of $200 million, or $1 per share, a year ago.
Analysts on average expected a loss of 96 cents per share, according to Thomson Reuters I/B/E/S.
Total revenue for the quarter of $114.4 million, including $74.5 million from Incivek sales, sailed past Wall Street revenue estimates of $54.3 million, according to Thomson Reuters I/B/E/S.
A review of recent analyst expectations for early Incivek sales compiled by ISI Group analyst Mark Schoenebaum found a mean estimate of $31 million.
Incivek is competing with a similar new drug from Merck & Co (MRK.N) called Victrelis. Incivek prescriptions have been outpacing Victrelis at a rate of better than 3-to-1 in the early going, according to data compiled by Wolters Kluwer's inThought unit.
"Physicians are opting for the drug that's easier to use and that's Incivek," Porges said.
Vertex shares rose 3.8 percent to $49.80 in extended trading from their Nasdaq close at $47.98.
Vertex also said it would file an application seeking U.S. approval of its experimental cystic fibrosis drug VX-770 in October. It had previously said it would file sometime in the second half of the year.
(Reporting by Bill Berkrot; Editing by Tim Dobbyn and Gunna Dickson)
.
“Upon approval in May, Vertex was prepared to immediately make INCIVEK available to people with hepatitis C, and the first person was able to begin treatment just three days after approval. We are very pleased with the launch of this important new medicine.”
The company reported approximately $75 million in net product revenues for INCIVEK in the second quarter. Vertex ended the quarter with a cash position of approximately $593 million and expects to become a cash flow and earnings positive company for 2012. The company also today provided several updates to its development-stage programs in hepatitis C, cystic fibrosis (CF), rheumatoid arthritis and influenza. The company noted that it plans to submit its New Drug Application (NDA) in the United States and Marketing Authorization Application (MAA) in the European Union for VX-770 in October 2011 for people with CF who have a specific mutation known as G551D. Vertex is also preparing to initiate multiple additional studies in CF, including two studies to evaluate combinations of Vertex’s investigational CF medicines planned for later this year and three additional studies of VX-770 planned to begin in the first half of 2012.
“The second quarter of 2011 was marked by several defining events for our company, including the approval and launch of INCIVEK for the treatment of hepatitis C and the completion of the Phase 3 program for VX-770 in cystic fibrosis,” said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex.
“Upon approval in May, Vertex was prepared to immediately make INCIVEK available to people with hepatitis C, and the first person was able to begin treatment just three days after approval. We are very pleased with the launch of this important new medicine.”
Recent Clinical Development Progress
Hepatitis C:
Positive Opinion Issued by European Committee for Medicinal Products for Human Use (CHMP) for Telaprevir
Vertex’s collaborator, Tibotec Virco-Virology BVBA, one of the Janssen Pharmaceutical companies of Johnson & Johnson, announced last week that the CHMP adopted a positive opinion to recommend the approval of telaprevir in Europe. The positive opinion will be considered by the European Commission, which has authority to approve new medicines for use throughout the European Union.
Vertex expects that Tibotec will receive a response from the European Commission on their application for approval in the third quarter of 2011. Following marketing authorization approvals, telaprevir will be marketed in the European Union and certain other global territories under the brand name INCIVOTM by the Janssen companies.
Enrollment Complete in Phase 3b Study of Twice-daily Dosing of INCIVEK
Patient enrollment is complete in a Phase 3b clinical trial to evaluate twice-daily dosing of INCIVEK (1,125 mg; BID) compared to three-times-daily dosing of INCIVEK (750 mg; q8h) in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) for people with chronic genotype 1 hepatitis C. Sustained viral response (SVR, or viral cure) data from OPTIMIZE are expected as early as the second half of 2012, which could support the submission of a supplemental NDA for twice-daily dosing of INCIVEK by the end of 2012.
Interim Results from Phase 2 Combination Study of INCIVEK and VX-222
In a separate press release issued earlier this week, Vertex announced results from an interim analysis of the two, four-drug (quad) arms of an ongoing Phase 2 clinical trial evaluating multiple 12- and 24-week response-guided regimens of Vertex’s lead investigational hepatitis C virus polymerase inhibitor, VX-222, dosed in combination with INCIVEK.
The study currently includes four treatment arms. Two of the arms are fully enrolled and are evaluating four-drug combinations of VX-222 (400 mg or 100 mg; BID), INCIVEK (1,125 mg; BID), pegylated-interferon and ribavirin. The third and fourth arms are three-drug treatment arms that are evaluating a twice-daily, all-oral, interferon-free regimen of INCIVEK (1,125 mg), VX-222 (400 mg) and ribavirin in people with genotype 1a or 1b chronic hepatitis C. Vertex expects to complete enrollment in the all-oral arms in the third quarter of 2011.
Data from this study will be submitted for presentation at a medical meeting later this year.
Phase 2 Study of INCIVEK Combination Treatment Evaluating 12-week Regimens on Track to Begin in the Third Quarter
IL28B gene
Vertex plans to begin a Phase 2 trial in the third quarter that will evaluate a treatment regimen of INCIVEK dosed in combination with pegylated-interferon and ribavirin for people who have a specific genetic marker, known as CC, near the IL28B gene. All people in the study will receive 12 total weeks of treatment. The trial is expected to include approximately 400 people with genotype 1 chronic hepatitis C who have not previously been treated. Data from this trial are expected in 2012.
Continue reading..............
UPDATE 2-New Vertex hepatitis drug shines out of gate
* EPS loss of $0.85 vs Street view loss $0.96
* Incivek sales $74.5 million in first five weeks
* Shares rise 3.9 percent (Adds analyst comment, expectations, share move)
By Bill Berkrot
NEW YORK, July 28 (Reuters) - Vertex Pharmaceuticals Inc's (VRTX.O) new hepatitis C drug stormed out of the gate, posting sales of nearly $75 million in its first five weeks on the market, and the company's shares rose nearly 4 percent.
Incivek, which is likely to become part of the standard of care for hepatitis C and widely expected to become a multibillion-dollar seller, won U.S. approval in May.
"This is a really, really impressive revenue ramp," Sanford Bernstein analyst Geoffrey Porges said. "You run this trend forward and you get to $200 million in revenue in the third quarter."
Investors who have been shorting the Vertex stock with a view that Incivek was bound to fall shy of sky-high expectations "are going to be in a world of pain tomorrow," Porges predicted.
The company reported a narrower and smaller-than-expected second-quarter net loss as the high cost of launching its first commercial product and higher research and development expenses were offset by strong early demand for the new medicine.
The biotechnology company on Thursday posted a net loss of $174.1 million, or 85 cents per share, compared with a loss of $200 million, or $1 per share, a year ago.
Analysts on average expected a loss of 96 cents per share, according to Thomson Reuters I/B/E/S.
Total revenue for the quarter of $114.4 million, including $74.5 million from Incivek sales, sailed past Wall Street revenue estimates of $54.3 million, according to Thomson Reuters I/B/E/S.
A review of recent analyst expectations for early Incivek sales compiled by ISI Group analyst Mark Schoenebaum found a mean estimate of $31 million.
Incivek is competing with a similar new drug from Merck & Co (MRK.N) called Victrelis. Incivek prescriptions have been outpacing Victrelis at a rate of better than 3-to-1 in the early going, according to data compiled by Wolters Kluwer's inThought unit.
"Physicians are opting for the drug that's easier to use and that's Incivek," Porges said.
Vertex shares rose 3.8 percent to $49.80 in extended trading from their Nasdaq close at $47.98.
Vertex also said it would file an application seeking U.S. approval of its experimental cystic fibrosis drug VX-770 in October. It had previously said it would file sometime in the second half of the year.
(Reporting by Bill Berkrot; Editing by Tim Dobbyn and Gunna Dickson)
.
Video; Hepatitis C cure
Published on Jul 28, 2011
by CBSNewsOnline
The Early Show: Hepatitis C cure rate doubled with new drug
More than three million Americans are infected with hepatitis C, a blood-borne virus that's linked to 12,000 deaths every year. "Early Show" medical correspondent Dr. Jennifer Ashton reports on a powerful new drug therapy that is giving new hope to the infected.
More than three million Americans are infected with hepatitis C, a blood-borne virus that's linked to 12,000 deaths every year. "Early Show" medical correspondent Dr. Jennifer Ashton reports on a powerful new drug therapy that is giving new hope to the infected.
J&J cuts maximum Tylenol dose to prevent overdoses
Linda A. Johnson, AP Business Writer, On Thursday July 28, 2011, 3:18 pm
TRENTON, N.J. (AP) -- Johnson & Johnson said Thursday that it's reducing the maximum daily dose of its Extra Strength Tylenol pain reliever to lower risk of accidental overdose from acetaminophen, its active ingredient and the top cause of liver failure.
The company's McNeil Consumer Healthcare Division said the change affects Extra Strength Tylenol sold in the U.S. -- one of many products in short supply in stores due to a string of recalls.
Starting sometime this fall, labels on Extra Strength Tylenol packages will now list the maximum daily dose as six pills, or a total of 3,000 milligrams, down from eight pills a day, or 4,000 milligrams. Beginning next year, McNeil will also reduce the maximum daily dose for its Regular Strength Tylenol and other adult pain relievers containing acetaminophen, the most widely used pain killer in the country.
Besides Tylenol, acetaminophen is the active ingredient in the prescription painkillers Percocet and Vicodin and in some nonprescription pain relievers, including NyQuil and some Sudafed products. It's found in thousands of medicines taken for headaches, fever, sore throats and chronic pain.
But people taking multiple medicines at once don't always realize how much acetaminophen they are ingesting, partly because prescription drug labels often list it under the abbreviation "APAP."
Two years ago, a panel of advisers to the Food and Drug Administration called for sweeping restrictions to prevent accidental fatal overdoses of acetaminophen.
Then in January, the FDA said it would cap the amount of acetaminophen in Vicodin, Percocet and other prescription pain killers at 325 milligrams per capsule -- just under half the 700 milligram maximum of some products on the market then. The agency also said it was working with pharmacies and other medical groups to develop standard labeling for acetaminophen.
"Acetaminophen is safe when used as directed," Dr. Edwin Kuffner, McNeil's head of over-the-counter medical affairs, said in a statement. "McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing."
Excessive use of acetaminophen can cause liver damage. In the U.S., it's blamed for about 200 fatal overdoses and sends 56,000 people to the emergency room each year.
McNeil spokeswoman Bonnie Jacobs said other makers of pain relievers are likely to make similar changes to their product labels.
Extra Strength Tylenol is manufactured at a J&J factory in Las Piedras, Puerto Rico, where production has been decreased for months because the FDA, concerned about manufacturing and quality problems, is requiring additional reviews and approvals before medicines can be shipped. J&J said shipments of Extra Strength Tylenol should ramp up in the latter part of this year and throughout next year.
Las Piedras is one of three factories implicated in a series of 25 recalls since September 2009 that have included tens of millions of bottles of Tylenol and other nonprescription drugs, several prescription drugs, hip implants and contact lenses made by Johnson & Johnson.
The recalls, for quality problems ranging from metal shavings and improper levels of active ingredients in some medicines to painfully defective hip implants and packaging with a nauseating odor, resulted in a consent decree with the FDA this spring.
As a result, Las Piedras and a second factory, in Lancaster, Pa., are under additional scrutiny. The third factory, in Fort Washington, Pa., made children's medicines such as liquid Tylenol. It has been closed since April 2010 and is being gutted and completely rebuilt.
Jacobs said the label changes are not related to the recalls.
http://finance.yahoo.com/news/JampJ-cuts-maximum-Tylenol-apf-3668085444.html?x=0&.v=5
TRENTON, N.J. (AP) -- Johnson & Johnson said Thursday that it's reducing the maximum daily dose of its Extra Strength Tylenol pain reliever to lower risk of accidental overdose from acetaminophen, its active ingredient and the top cause of liver failure.
The company's McNeil Consumer Healthcare Division said the change affects Extra Strength Tylenol sold in the U.S. -- one of many products in short supply in stores due to a string of recalls.
Starting sometime this fall, labels on Extra Strength Tylenol packages will now list the maximum daily dose as six pills, or a total of 3,000 milligrams, down from eight pills a day, or 4,000 milligrams. Beginning next year, McNeil will also reduce the maximum daily dose for its Regular Strength Tylenol and other adult pain relievers containing acetaminophen, the most widely used pain killer in the country.
Besides Tylenol, acetaminophen is the active ingredient in the prescription painkillers Percocet and Vicodin and in some nonprescription pain relievers, including NyQuil and some Sudafed products. It's found in thousands of medicines taken for headaches, fever, sore throats and chronic pain.
But people taking multiple medicines at once don't always realize how much acetaminophen they are ingesting, partly because prescription drug labels often list it under the abbreviation "APAP."
Two years ago, a panel of advisers to the Food and Drug Administration called for sweeping restrictions to prevent accidental fatal overdoses of acetaminophen.
Then in January, the FDA said it would cap the amount of acetaminophen in Vicodin, Percocet and other prescription pain killers at 325 milligrams per capsule -- just under half the 700 milligram maximum of some products on the market then. The agency also said it was working with pharmacies and other medical groups to develop standard labeling for acetaminophen.
"Acetaminophen is safe when used as directed," Dr. Edwin Kuffner, McNeil's head of over-the-counter medical affairs, said in a statement. "McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing."
Excessive use of acetaminophen can cause liver damage. In the U.S., it's blamed for about 200 fatal overdoses and sends 56,000 people to the emergency room each year.
McNeil spokeswoman Bonnie Jacobs said other makers of pain relievers are likely to make similar changes to their product labels.
Extra Strength Tylenol is manufactured at a J&J factory in Las Piedras, Puerto Rico, where production has been decreased for months because the FDA, concerned about manufacturing and quality problems, is requiring additional reviews and approvals before medicines can be shipped. J&J said shipments of Extra Strength Tylenol should ramp up in the latter part of this year and throughout next year.
Las Piedras is one of three factories implicated in a series of 25 recalls since September 2009 that have included tens of millions of bottles of Tylenol and other nonprescription drugs, several prescription drugs, hip implants and contact lenses made by Johnson & Johnson.
The recalls, for quality problems ranging from metal shavings and improper levels of active ingredients in some medicines to painfully defective hip implants and packaging with a nauseating odor, resulted in a consent decree with the FDA this spring.
As a result, Las Piedras and a second factory, in Lancaster, Pa., are under additional scrutiny. The third factory, in Fort Washington, Pa., made children's medicines such as liquid Tylenol. It has been closed since April 2010 and is being gutted and completely rebuilt.
Jacobs said the label changes are not related to the recalls.
http://finance.yahoo.com/news/JampJ-cuts-maximum-Tylenol-apf-3668085444.html?x=0&.v=5
National Minority Quality Forum Launches the Hepatitis C Index
National Minority Quality Forum Launches the Hepatitis C Index
New tool to help identify areas for increased education and screening for hepatitis C
WASHINGTON, July 28, 2011 /PRNewswire-USNewswire/ -- In recognition of World Hepatitis Day, the National Minority Quality Forum today launched the Hepatitis C Index, a novel resource for mapping hepatitis C (http://www.maphepc.com).
For the first time, health-care practitioners, policy makers, advocacy groups, and researchers will be able to quantify and map hepatitis C (HCV) prevalence and total counts at the zip-code level for the United States as well as for individual states, counties, metropolitan statistical areas, and federal and state legislative districts. In addition, the index maps HCV by age, gender and race/ethnicity. Index users may generate color-coded maps of hepatitis C prevalence, total counts and hospitalizations rates for downloading, printing, and dissemination to support educational and advocacy initiatives.
''Identifying where hepatitis C is most prevalent may encourage early screening and surveillance efforts and help to realize our national goal of prevention and control of HCV infections in the United States," says Charles Howell, MD, Director, hepatology research, University of Maryland School of Medicine.
Hepatitis C prevalence disproportionately affects blacks (2.7%) versus whites (1.4%), and is highest among the 40-64 age group (3.1%); the New York, Los Angeles, and Chicago metropolitan areas are ranked one to three for total HCV infections (source: Hepatitis C Index).
"Hepatitis C has infected nearly 4 million persons in the United States; almost 20% of HCV patients are hospitalized annually, resulting in a tremendous burden on our U.S. health care system. These data derived from the Hepatitis C Index serve as a reminder that the need exists for improved HCV surveillance, and better targeting of HCV services to remedy this healthcare problem," notes Gary Puckrein, PhD, CEO of the National Minority Quality Forum.
The Hepatitis C Index was developed with financial support from Vertex Pharmaceuticals.
The National Minority Quality Forum (www.nmqf.org) is a non-profit healthcare research and educational organization dedicated to the elimination of health disparities. The Forum supports national and local efforts to eliminate the disproportionate burden of premature death and preventable illness in racial and ethnic minorities and other special populations. The Forum has introduced user-friendly, web-based disease atlases and indexes to provide a unique two-dimensional view of various diseases, including diabetes, heart disease, lung cancer, kidney disease, HIV/AIDS, and MRSA by zip code. Users now have an unprecedented objective and reliable source of integrated data to validate the existence of health disparities.
SOURCE National Minority Quality Forum
RELATED LINKShttp://www.nmqf.org
New tool to help identify areas for increased education and screening for hepatitis C
WASHINGTON, July 28, 2011 /PRNewswire-USNewswire/ -- In recognition of World Hepatitis Day, the National Minority Quality Forum today launched the Hepatitis C Index, a novel resource for mapping hepatitis C (http://www.maphepc.com).
For the first time, health-care practitioners, policy makers, advocacy groups, and researchers will be able to quantify and map hepatitis C (HCV) prevalence and total counts at the zip-code level for the United States as well as for individual states, counties, metropolitan statistical areas, and federal and state legislative districts. In addition, the index maps HCV by age, gender and race/ethnicity. Index users may generate color-coded maps of hepatitis C prevalence, total counts and hospitalizations rates for downloading, printing, and dissemination to support educational and advocacy initiatives.
''Identifying where hepatitis C is most prevalent may encourage early screening and surveillance efforts and help to realize our national goal of prevention and control of HCV infections in the United States," says Charles Howell, MD, Director, hepatology research, University of Maryland School of Medicine.
Hepatitis C prevalence disproportionately affects blacks (2.7%) versus whites (1.4%), and is highest among the 40-64 age group (3.1%); the New York, Los Angeles, and Chicago metropolitan areas are ranked one to three for total HCV infections (source: Hepatitis C Index).
"Hepatitis C has infected nearly 4 million persons in the United States; almost 20% of HCV patients are hospitalized annually, resulting in a tremendous burden on our U.S. health care system. These data derived from the Hepatitis C Index serve as a reminder that the need exists for improved HCV surveillance, and better targeting of HCV services to remedy this healthcare problem," notes Gary Puckrein, PhD, CEO of the National Minority Quality Forum.
The Hepatitis C Index was developed with financial support from Vertex Pharmaceuticals.
The National Minority Quality Forum (www.nmqf.org) is a non-profit healthcare research and educational organization dedicated to the elimination of health disparities. The Forum supports national and local efforts to eliminate the disproportionate burden of premature death and preventable illness in racial and ethnic minorities and other special populations. The Forum has introduced user-friendly, web-based disease atlases and indexes to provide a unique two-dimensional view of various diseases, including diabetes, heart disease, lung cancer, kidney disease, HIV/AIDS, and MRSA by zip code. Users now have an unprecedented objective and reliable source of integrated data to validate the existence of health disparities.
SOURCE National Minority Quality Forum
RELATED LINKShttp://www.nmqf.org
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