New Labels Coming for OTC Painkillers--May 2009


Manufacturers of OTC painkillers and fever reducers have 1 year to relabel all their products to include warnings about potential safety risks, such as liver damage and internal bleeding, according to a new FDA rule. The agency reported that some manufacturers have already voluntarily started listing some of these risks on their product labels.

Products covered by the FDA's action include acetaminophen and a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. The modified labeling applies to all products that contain these ingredients, such as cold medicines. In addition, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

"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, MD, director of the 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."

The American Pain Foundation (APF) supports the new rule. "This ruling will not only help protect consumers using OTC pain and fever medications on a periodic basis, but will be especially meaningful for people suffering from chronic pain who may face comorbid conditions and are taking OTC pain medication along with their prescribed pain medication," said APF in a statement.

The Consumer Healthcare Products Association said it continues to work with manufacturers on implementing the changes. The association's Web site offers guidelines, tips, and resources on the safe OTC medicine use available in English and Spanish.

For other articles in this issue, see:

Drug Companies Ramp Up Swine Flu Drug Production

Medication Errors Cut with Pharmacist Intervention

On the Horizon--Performance-Based Contracts for Drugs?

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