Over the counter pain relievers to carry additional warnings
The use of many popular over-the-counter (OTC) pain relievers carry the risks of side effects, and from now on, the American Food and Drug Administration (FDA) says those risks have to be spelled out in detail on the product labels.
The FDA has issued a final ruling that requires manufacturers of OTC pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks associated with the use of these popular drugs.
Products covered by the FDA action include a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen.
The revised labeling 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. The warning will state that the potential side effects include internal bleeding and liver damage.
Under the final rule, 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.
Since 2006, some manufacturers have voluntarily revised their product labeling to identify these potential safety concerns. However, the voluntary changes to labeling do not address all of the labeling requirements in the new rule, the FDA says,
The risk for stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs (anticoagulants) or steroids. Stomach bleeding risks also increase for people who take multiple NSAIDs at the same time, or in people who take them longer than directed.
Alcohol use can increase the risk for stomach bleeding with with NSAIDs use.
