Drug Policy

Killer Painkillers

The war on Tylenol

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Stock up on your Vicodin, because it might not be legal for long.

In June an advisory committee recommended that the Food and Drug Administration (FDA) tighten restrictions on the use of the painkiller acetaminophen in both over-the-counter and prescription medications. In a study conducted between 1998 and 2003, the FDA concluded that overconsumption of acetaminophen was "the leading cause of acute liver failure." 

At issue are "combination medications" such as Tylenol Allergy, which mix acetaminophen with other drugs. The panel worried that combination medications make it difficult for consumers to gauge their total acetaminophen intake, increasing the risk of liver damage. In a lopsided vote, panelists recommended reducing the highest dose allowable in over-the-counter medications. But the panel split on its most controversial decision, approving by a thin margin a recommendation to ban the combination of acetaminophen and narcotics.

Such a prohibition would pull prescription painkillers such as Vicodin and Percocet off the pharmacy shelves. The FDA already has ordered the pharmaceutical industry to add prominent liver-damage warnings to medication containing acetaminophen.

The problem of acetaminophen overdoses may be exaggerated. The FDA estimates that 400 Americans die from the drug each year. That's a tiny fraction of the 200 billion doses of acetaminophen sold nationwide last year. According to the FDA, "many cases of liver injury with acetaminophen result from self-harm, i.e., intentional selfpoisoning." Rather than taking effective and commonly used painkillers off the shelves, perhaps the FDA should consider a large-print label reading "Do Not Use to Commit Suicide."