FDA Requires Stronger Warning Labels on Painkillers
Posted by
Jessica SmagaczApril 29, 2009 11:41 AMAccording to the Wall Street Journal, FDA finalized rules yesterday requiring stronger labeling on over-the-counter painkillers warning consumers about risks of stomach bleeding or livery injury.
Back in 2006, many manufacturers actually voluntarily added new warnings after FDA made proposals to change the warnings. However, the warnings did not address all the requirements set in the final rule.
These new rules apply to acetaminophen which is sold as the brand name Tylenol. FDA’s rules apply to nonsteroidal anti-inflammatory drugs, or NSAIDS. This includes aspirin, ibuprofen, naproxen and ketoprofen. [brand names include Advil and Motrin]
FDA said that these manufacturers must ensure the active ingredients of the drugs are prominently displayed on the drug labels on both packages and the bottles. Included in these warnings must be the warning of the risks of stomach bleeding for NSAIDs and sever liver damage for acetaminophen.
“FDA said the risk for livery injury increases when people take more than the recommended dose of acetaminophen, either on purpose or unknowingly by using multiple products containing acetaminophen.” That’s certainly not good!
The risks associated with stomach bleeding and liver injury while taking these medications certainly calls for more warnings. However, do you think consumers will actually read the labels?