April 29, 2009
FDA requires additional labeling for OTC analgesics and antipyreticsThe FDA has issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks (eg, internal bleeding, liver damage, concomitant warfarin therapy) associated with the use of these drugs and to prominently display the active ingredients on the drug labels of both the packages and bottles. This FDA action applies to all products that contain acetaminophen and nonsteroidal antiinflammatory drugs (NSAIDs), including aspirin, ibuprofen, naproxen, and ketoprofen. The revised labeling will also apply to products that contain one of these ingredients in combination with other ingredients, such as in cold medicines. Manufacturers will have one year to relabel their products.
For more information visit www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.