September 22, 2002	Sunday	Rajab 14, 1423

SILVER SPRING, Sept 21: 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 on Friday.

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 & Johnson’s Tylenol and dozens of other nonprescription drugs. High doses of acetaminophen can cause liver damage.

Severe problems are rare when the drugs are taken at their recommended nonprescription 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 doctor’s supervision.

Panel members suggested that labels state that stomach risks are elevated for people older than 65, those taking certain drugs such as anti-clotting medicines and people with a history of stomach ulcers.

For those groups, labels should encourage consumers to consult a doctor before taking the medicines. They also called for warnings that people should not take multiple NSAIDs at the same time because that also may increase the chances of harm.—Reuters