FDA orders more warnings for OTC drugs

WASHINGTON, April 28 (UPI) -- The U.S. Food and Drug Administration says it will require manufacturers of over-the-counter pain relievers and fever reducers to include safety warnings.

The FDA said OTC analgesics and fever reducers will have to include warnings about potential safety risks such as internal bleeding and liver damage, associated with the use of such popular drugs.

Products covered by the FDA action include acetaminophen and a class of drugs known as the non-steroidal anti-inflammatory drugs. Such NSAIDs include aspirin, ibuprofen, naproxen and ketoprofen. Acetaminophen is in a class by itself.

"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 Dr. Charles Ganley, director of the FDA's Office of Non-prescription Drugs. "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."

Under the new FDA rule, manufacturers must list all active ingredients prominently on 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.

The new rule is available at http://www.federalregister.gov/OFRUpload/OFRData/2009-09684_PI.pdf.