FDA Advisory Panel Recommends Banning Vicodin and Percocet
An FDA advisory panel recently recommended banning Vicodin and Percocet – two of the most popular painkiller available – due to concerns about the amount of acetaminophen in the drugs. Karen Lee Richards discusses the recommendation.
The reason the FDA is considering changing their recommendations is that acetaminophen overdose is currently the leading cause of liver failure in the U.S.
The advisory panel recommended banning hydrocodone and oxycodone products (like Vicodin and Percocet) that contain acetaminophen. Vicodin and its generic counterparts contain hydrocodone and acetaminophen. Percocet and its generic formulations contain oxycodone and acetaminophen.
Acetaminophen is not uncommon – it is in many over-the-counter drugs, including Tylenol and cold/flu medication. For this reason, taking one of these OTC drugs combined with either Percocet or Vicodin could result in an overdose.
The FDA panel has recommended lowering the maximum recommended dose of acetaminophen from 1,000 mg per dose to 650 mg. They also recommended lowering the maximum daily dose, which is currently 4 grams (4,000 mg). Although they didn't specify what the maximum daily dose should be lowered to, it would most likely be in the neighborhood of 2,600 mg per day.
No. The FDA is not required to take the recommendation of the advisory panel, although they usually do. Since the vote to ban Vicodin and Percocet-type drugs was so close, perhaps they will give it some extra consideration.
An FDA advisory panel also recommended removing painkillers Darvon and Darvocet from the market. The drug-maker then voluntarily pulled the drug, due to a potentially deadly link to heart rhythms.