Makers of over-the-counter (OTC) pain relievers and fever reducers must revise their labeling to include warnings about potential safety risks associated with these popular drugs. These risks include internal bleeding and liver damage.
Final Rule
In a final rule issued on April 28, 2009, the Food and Drug Administration (FDA) directed that labeling be revised for acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs). These are two classes of commonly used drugs that are effective in reducing fevers and relieving minor aches and pain such as headaches and muscle aches. NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen.
The final rule applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.
Under the final rule, manufacturers must
- ensure that the labeling warns of the risk of stomach bleeding for NSAIDs and the risk of severe liver damage for acetaminophen
- ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both packages and bottles
- revise the product labeling within one year of the date the rule was issued
For More Information
FDA Press Release
www.fda.gov/bbs/topics/NEWS/2009/NEW02004.html
A Guide to Safe Use of Pain Medicine
www.fda.gov/consumer/updates/painmeds022309.html
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