Darvon, Darvocet get stronger FDA warnings but no bans
The FDA ordered stronger warnings today about the risk of overdose from the drugs Darvon and Darvocet, but rejected calls for an outright ban of the painkillers.
The announcement comes in the middle of a media flurry about the possible dangers of acetaminophen. The pain killer and fever reducer is the main ingredient in Tylenol, and is also found in many other medications, including Darvocet, Percocet, and vicodin.
The FDA has not yet decided whether to ban Percocet and Vicodin. An FDA advisory panel has recommended that the agency ban the drugs and set limits on the amount of acetaminophen in each over-the-counter pill.
The advisory panel cited the risk of liver failure in people who take high doses of acetaminophen over an extended period. The drug accounts for about 30 percent of all liver failures in the United States.
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Johnson & Johnson, the company that makes Tylenol, strongly disagrees with the panel's proposal.
All Things Considered's medical analyst Dr. Jon Hallberg said that medical professionals have always been aware of the risks of liver failure when taking high doses of the medication.
"There's no perfectly safe drug on the market," Hallberg told MPR's Tom Crann Tuesday. "Every supplement, every drug we take, has the potential to cause problems."
Hallberg cautioned against over-reaction to the FDA controversy. "A lot of people are taking this story as, 'Tylenol is dangerous. Acetaminophen is bad,' he said. "That is not true. This is a very safe drug. If you've got a headache, if you've got a kid with a fever, acetaminophen is going to be a very effective, safe way of treating that."
