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FDA Panel Calls for Ban on Narcotic/Tylenol Combo Drugs

Two variations of Vicodin, with different amou...
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A joint committee of three FDA advisory groups voted on Tuesday to recommend the elimination of prescription combination drugs containing acetaminophen due to a spike in instances of liver-induced toxicity.

The panel of experts, physicians, and regulators voted 20 to 17 in favor of banning acetaminophen combo drugs such as Vicodin and Percocet. They made it clear, however, that they are not calling for a ban on acetaminophen alone, or banning the narcotic component of the pain drugs—just those factors in tandem.

“The top recommendation of the committee is that the agency needs to do something to address and decrease the ‘usual dose’ of acetaminophen for OTC products and prescription combination products,” said Sharon Hertz, deputy director, Division of Anesthesia, Analgesia, and Rheumatology Products, CDER. “The usual dose that people take, whether it’s called the single dose or the maximum daily dose, should be lowered to ensure a greater margin of safety.”

With regard to prescription products, FDA said that there is a high likelihood of overdose of prescription narcotic acetaminophen products, and if those products are not eliminated the acetaminophen dose should be lowered significantly. The panel also suggested boxed warnings so that physicians will be more aware of the potential for liver damage.

“This is clearly an issue that’s been on FDA’s mind for a long time,” said Gerald Dal Pan, director, Office of Surveillance and Epidemiology, CDER. “In 2007, we looked at the results of an education campaign, and formed an internal group at CDER to examine the issue and report some recommendations. This is the result of those recommendations.”

FDA said that there is no silver bullet to reverse the trend, and that label changes and public awareness campaigns wouldn’t have solved the problem.

No Surprise

“This is not a problem that arose overnight,” Hertz said. “The problem is very complicated and has multiple components. There probably isn’t one thing that will reverse the trend of acetaminophen-related liver toxicity. In addition, all of the components of the problem are moving at the same time that use patterns are changing. New products are coming and going from the market, and different patterns of prescribing are occurring.”

OTC combination drugs such as NyQyil are not in question, Nelson said, because data showed indicated many deaths each year from prescription combination products, and deaths from OTC treatments are far lower.

“Based on that epidemiology, you get more bang for the buck by eliminating prescription drugs,” Nelson said.

FDA is now going to back and look at the discussion and decide whether they want to move on the advisory panel’s suggestion. Pharma companies are being encouraged to change their labels and address dosage quantities before FDA announces any changes.

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