Vicodin, Percocet Bans Could Be On the Way

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By David Goguen on July 01, 2009 8:04 AM

The widely-prescribed painkillers Vicodin and Percocet could be banned in the U.S., if the FDA follows the recommendations of a panel of medical experts that met earlier this week.

The advisory panel assembled on Monday and Tuesday to evaluate the health risks of over-the-counter and prescription medications containing acetaminophen, and to recommend a course of action that might reduce health problems associated with these products -- specifically, the incidence of liver damage caused by high doses of acetaminophen. (For more background, see FDA Looking at Acetaminophen and Liver Damage.)

The panel looked at OTC acetaminophen medications like Tylenol and Excedrin; OTC "combination drugs" like NyQuil and Theraflu, which include acetaminophen and cold medications; and prescription drugs like Vicodin and Percocet that combine potent levels of acetaminophen with a narcotic.

After meeting on Monday and Tuesday, the advisory panel voted to make the following recommendations to the FDA, as reported today by the New York Times:

  • An outright ban on combination prescription painkillers like Vicodin and Percocet.
  • A reduction in the highest allowable dosage of acetaminophen in OTC drugs like Tylenol and Excedrin, down to 325 milligrams per pill (from 500).
  • A reduction in the maximum allowable daily dosage of acetaminophen, to under 4,000 milligrams per day.

The popularity of acetaminophen products in the U.S. medicine market is difficult to overstate. In 2005, Americans bought 28 billion doses of medication containing acetaminophen; and on the prescription side, Vicodin and its generic versions are prescribed over 100 million times a year, according to the Times. But acetaminophen-related liver injury is also the leading cause of acute liver failure in the U.S., the FDA says.

The FDA is not legally obligated to -- but typically does -- follow the recommendations of the medical experts on its advisory panels. So, official FDA restrictions on acetaminophen products may be right around the regulatory corner.