Silver Spring (Maryland), Sept. 21 (Reuters): Aspirin, ibuprofen and some other over-the-counter painkillers should come with stronger warnings about the risk of potentially serious stomach bleeding, US advisers said yesterday.
A Food and Drug Administration advisory panel recommended more explicit warnings about that long-known side effect, which occurs in only a small fraction of cases but can be fatal, with details about who faces the highest risk. Current labels refer to the possibility of stomach harm, but panel members said they wanted stronger messages.
A majority of panelists also supported additional warnings about possible kidney damage on labels for ibuprofen and aspirin.
The FDA is in the process of reviewing labels on over-the-counter pain relievers. On Thursday, the panel recommended stronger warning labels on medicines containing acetaminophen, a pain reliever used in Johnson & Johnsonís Tylenol and dozens of other non-prescription drugs. High doses of acetaminophen can cause liver damage.
Tens of millions of Americans use aspirin and other medicines known as non-steroidal anti-inflammatory drugs, or NSAIDs, to relieve aches and pains and reduce fevers. Millions also take aspirin daily to prevent heart attacks. Manufacturers include aspirin maker Bayer AG and Wyeth , which sells ibuprofen product Advil.
Severe problems are rare when the drugs are taken at their recommended non-prescription doses, regulators said. But they are concerned about patients who take the over-the-counter drugs for longer, and at higher doses, than advised and without a doctorís supervision.