FDA requires stronger OTC pain med labels

The FDA says it has ruled on a measure that requires manufacturers of over-the-counter pain relievers and fever reducers to include tougher safety warnings on their labels. Acetaminophens, such as Johnson & Johnson's Tylenol, must include warnings about the risk of liver damage.Makers of nonsteroidal anti-inflammatory drugs, which include aspirin, ibuprofen, naproxen and ketoprofen, are now required to warn users about the risks of stomach bleeding.  Alcohol use, taking more than the recommended dosage or using the meds longer than directed can all increase the chance of developing these severe side effects. And the FDA wants consumers who put themselves at risk to think twice. 

We believe the new labeling requirements will add information concerning severe adverse effects of over-the-counter pain relievers and fever reducers that many consumers may not be aware of," Matthew Holman, the FDA's deputy director for the Division of Nonprescription Regulation Development tells Reuters.

Since the proposal was first introduced in 2006, some manufacturers have already voluntarily changed their labeling. However, the FDA says the policy contains new label requirements not yet addressed by drugmakers. The new regulations apply to generics, as well as other OTC drugs that contain pain relivers, such as some cold medicines.

All manufacturers will have one year to revise their labeling.  

"Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, " said Charles Ganley, M.D., director, FDA's Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. "However, the risks associated with their use, need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk."

- here's the FDA statement
- more from Reuters

Related Articles:
Will FDA label regs shield pharma?
FDA mulls sweeping change to drug labels
FDA revamps drug labels (2006)