FDA Calls For Stricter Warnings on Tylenol and Other OTC Drugs

“Non-prescription pain relievers used by millions of U.S. consumers need stronger health warnings regarding liver or stomach risk, the Food and Drug Administration said Tuesday.” The drugs in questions are acetaminophen (Tylenol), and NSAIDs like ibuprofen (Advil, Motrin). In particular acetaminophen is associated with liver problems.

“A study published last year in Hepatology concluded that liver damage caused by acetaminophen exceeded other causes of U.S. drug-induced acute liver failure, but that most of the cases stemmed from accidental overdoses or suicide attempts. About 100 people in the USA die each year after accidental acetaminophen overdoses, the FDA says.”

Products Affected:
“NSAIDs: Aspirin, Advil and Motrin (ibuprofen), Aleve (naproxen)

Products with acetaminophen: Tylenol, Tylenol Children’s, Excedrin PM, Alka-Seltzer Plus Cold & Sinus, Sudafed Sinus & Cold.”

The new labeling would identify products that contain acetaminophen or NSAIDs clearly on the packaging (some cold medicines have these drugs and people don’t realize it) and warn consumers about the risk of stomach bleeding with NSAIDs and liver damage with acetaminophen, particularly when consumed with alcohol. So, if you’re drinking, don’t take Tylenol! —MEGHANN MARCO

FDA calls for pain reliever warning [USA Today]