Labels on common OTC pain remedies to include heightened risks

Warnings of liver toxicity and gastrointestinal bleeding likely could gain more attention from patients, the FDA says.

By Susan J. Landers, AMNews staff. Oct. 14, 2002.

Washington -- A Food and Drug Administration advisory panel's recommendation that warning labels on some popular pain relievers should be stronger may find doctors fielding queries from patients on which, if any, over-the-counter remedy is still right for them.

Despite widespread recommendations from physician groups that acetaminophen be the first drug of choice for pain relief and that low-dose aspirin be taken to ward off heart attacks, both drugs carry risks that could soon be spelled out on product labels.

In two days of hearings the FDA committee gathered views on acetaminophen, aspirin, ibuprofen and other nonsteroidal anti-inflammatory drugs from many consumer and pharmaceutical groups. On Sept. 19 the advisory committee recommended that labels on products containing acetaminophen be changed to better emphasize its inclusion.

About 200 OTC drugs, including cold and headache remedies, contain acetaminophen and could lead the unwary consumer, who may be taking two or more of the products, into an unwitting overdose.

The label should also indicate that taking products with acetaminophen in higher than recommended doses or for a longer duration than the label recommends could lead to liver damage, concluded the panel.

Acetaminophen, which is used safely by millions of people, is also thought to kill about 100 each year and result in the hospitalization of about 2,000 for liver toxicity.

The committee also advised adding the proper dosage for infants to the label rather than suggesting calling a physician or pharmacist. [...]