INFO - La FDA et les anti-douleurs Auj. à 01:30
A lire jusqu'à la fin, c'est
intéressant.
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http://www.re uters.com/article/healthNews/idUSTRE55S62120090630?feedType=RSS&feedName=hea lthNews
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FDA calls for ban of some pain drugs
Tue Jun 30, 2009 5:54pm EDT
By Susan Heavey
ADELPHI, Maryland (Reuters) - Prescription painkillers that include acetaminophen should be pulled from the U.S. market because they can make it too easy for patients to take dangerously high doses, a government advisory panel narrowly recommended on Tuesday.
A U.S. Food and Drug Administration panel of outside experts voted 20-17 to urge the agency to eliminate such products, which include, among others, Abbott Laboratories' Vicodin and Endo Pharmaceuticals' Percocet -- two drugs that combine acetaminophen with powerful opioids.
"This is clearly the biggest cause of overdose problems," said panelist Dr. Marie Griffin, a preventive medicine professor at Vanderbilt University Medical Center.
The recommendation is one of several from the panel, which is weighing potential steps the agency can take to help prevent liver damage and even death seen in patients who take too much acetaminophen.
Overdoses of acetaminophen, most commonly known as Johnson & Johnson's Tylenol, have long been known to cause liver failure and even death.
Acetaminophen use is the leading cause of acute liver failure in the 1,600 cases seen each year in the United States, according to a 2007 Centers for Disease Control and Prevention estimate.
FDA officials are concerned that warnings are not heeded by consumers and are looking for new ways to reduce the number of overdoses. The agency will weigh the panel's recommendations before making any final decisions.
Other makers of acetaminophen, or products that contain it, include Bayer AG, GlaxoSmithKline, Novartis, Perrigo Co, Procter & Gamble, Schering-Plough and Wyeth.
The panel stopped short of recommending a ban of over-the-counter cough, cold and other medications that combine acetaminophen with other ingredients, voting 24-13 to keep them on store shelves.
Still, it said over-the-counter pain drugs and other medications containing acetaminophen should come in lower doses and that the highest dose currently on the market should only be available with a doctor's prescription.
Johnson & Johnson's McNeil Consumer Healthcare unit, which makes Tylenol, said it strongly disagreed with that advice and that its products are safe. Changing dose strengths was "likely to lead to more serious adverse events as consumers shift to other over-the-counter products such as non-steroidal anti-inflammatory drugs," it said in a statement.
Those anti-inflammatory painkillers, also known as NSAIDs, which include aspirin and ibuprofen, are know to cause stomach bleeding. The FDA earlier this year called for stronger warnings for both NSAIDS and acetaminophen products to highlight the stomach and liver risks.
At the meeting, panelists also said additional changes to product packaging, including graphics, could also help alert consumers to the risks.
"I think we have to send the message that there are problems with this medication," said Winifred Landis, a pharmacist from Indiana.
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C'est tout bon pour le Naproxcinod tout ça
.
mica sei l'unico!
su col morale che l'estate è ancora lunga! 