The Food and Drug Administration issued a final rule Tuesday that requires manufactures of over-the-counter (OTC) products to revise their labeling including warnings about potential safety risks, such as internal bleeding and liver damage to help the consumers use products safely.
Products covered by the FDA action include acetaminophen and a class of drugs knows 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.
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 of NSAIDs and severe liver damage for acetaminophen.
An FDA Advisory Committee meeting will be convened on June 29-30 to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.