HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Monday, June 29, 2009

Working to Prevent Painkiller Damage

The Associated Press reports on the FDA's renewed focus on painkillers and their damaging side effects. The article provides,

Tylenol, Excedrin, NyQuil. These household brands and others have come to symbolize safe, convenient relief from the aches and pains of everyday life. But this week the Food and Drug Administration is focusing on a seldom-discussed side effect of the medications: severe liver damage. Since the drugs first became widely available in the 1950s, the FDA has tried to minimize the risks of acetaminophen — the pain-relieving, fever-reducing ingredient in Tylenol and dozens of other prescription and over-the-counter medications.

Acetaminophen overdoses send an estimated 56,000 people to the emergency room each year, according to the FDA.  Despite decades of educational campaigns, bolstered warnings and other federal actions, acetaminophen continues to be the leading cause of liver failure in the U.S. . .  .   

The FDA does not have to follow the group's advice, though it usually does. Individual companies already are sparring in an effort to influence the FDA's decision.   Panelists will be asked to vote on a range of options: adding a "black box" warning label to the products, lowering the drug dosage in some products, or pulling certain types of medications off the market — which could cost manufacturers millions in sales.  The drugs that could be pulled off store shelves are combination medications, such as Procter & Gamble's NyQuil or Novartis' Theraflu, which combine acetaminophen with other ingredients that treat cough and runny nose....

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