Ban Advised on Percocet and Vicodin

Posted on September 10th, 2009

If the FDA heeds the warnings of a federal advisory panel, Percocet and Vicodin, two powerful painkillers, could be banned from the US market. The panel recently voted to recommend a ban on the two drugs because of their damaging effects on the liver. Both drugs contain acetaminophen, the active ingredient in Tylenol and Excedrin, and high doses of acetaminophen are a leading cause of liver damage. The panel noted that people who take Percocet and Vicodin for long periods of time often need higher and higher doses to achieve the same painkilling effects.

If the ban is passed, at least seven other prescription drugs containing acetaminophen will also be taken off pharmacy shelves. Laureen Cassidy, a spokeswoman for Abbott Laboratories, which makes Vicodin, said that the FDA will make a final determination and that Abbott will follow the FDA’s guidelines. The agency is not required to follow the recommendations of its advisory panels but it usually does.

In 2005, Americans bought 28 billion doses of products containing acetaminophen. Vicodin and its generic equivalents are prescribed more than 100 million times a year in the US. In addition, more than 400 people die and 42,000 are hospitalized every year in the US from overdoses of drugs containing acetaminophen. While the medication is effective in alleviating pain and reducing fevers, even recommended doses can cause liver damage in some people.

The committee voted 24 to 13 to recommend that the FDA reduce the highest allowed dose of acetaminophen in over-the-counter pills like Tylenol from 500 milligrams to 325. In addition, members voted 21 to 16 to reduce the maximum daily dosage to less than 4,000 milligrams. However, they voted 20 to 17 against limiting the number of pills in each bottle, adding that this limit would probably have little effect and could hurt rural and poor patients.

Dr. Lewis S. Nelson, a toxicologist from the New York University School of Medicine and the panel’s acting chairman, said that experts have been warning of the dangers of combination painkillers like Percocet and Vicodin for years.

Some doctors already avoid prescribing pills that combine acetaminophen with narcotics like oxycodone (in Percocet) and hydrocodone (in Vicodin). Dr. Scott M. Fishman, a professor of anesthesiology at the University of California, Davis, said, “It ties the doctor’s hands when you put the two drugs together. There’s no reason you can’t get the same effect by using them separately.” He also said that the combinations are often prescribed for the sake of convenience.

Acetaminophen is included in many over-the-counter cough and cold products including Nyquil. Some accidental poisonings occur when people take two or more of these combination products. The FDA asked the committee whether it should ban all combination products that contain acetaminophen, but the vote was 24 to 13 against such a ban.

Dr. Osemwota A. Omoigui, a panel member from the Los Angeles Pain Clinic, said that combination over-the-counter medications contributed very little to overall poisonings. A 2005 study found that most poisonings resulted from patients taking Vicodin and similar products that combine acetaminophen with a narcotic.

Most panel members agreed that consumers need to be better educated about the risks of popular medicines. “If you keep track of what you’re taking, none of this is an issue for you,” said Dr. Jan Engle, a panel member and head of the Department of Pharmacy Practice at the University of Illinois in Chicago.
 

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