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CENTRAL ARIZONA COLLEGE
DIRECTOR OF HEALTH INFORMATION MANAGEMENT

WASHINGTON — Drugstore headache medicines would carry warnings about risks of liver damage and stomach bleeding under rules proposed by U.S. regulators, and packages would clearly identify the main ingredient.

Aspirin, ibuprofen, acetaminophen and the other related over-the-counter drugs remain safe and effective when used as directed, the Food and Drug Administration said.

However, overdoses of acetaminophen can cause serious liver damage, even death, the FDA said.

For aspirin, ibuprofen and other nonsteroidal anti-inflammatory drugs, there is a risk of gastrointestinal bleeding and kidney injury even when patients take the correct dose. Those risks too are linked to deaths, in this case thousands each year. The FDA cautioned the risk is rare when compared to the number of patients who take the drugs.

Experts called the stepped-up warnings long overdue, since federal advisers had called for similar label changes in 2002. An FDA official chalked it up to the time required to write new regulations.

The drugs are found in hundreds of medicines sold to treat pain, headache and fever. Health officials worry that the wide availability of those combination products can lead to patients unintentionally overdosing. Doctors report cases of patients taking two or more medicines — say, one for pain and another for flu symptoms — without knowing they both contain acetaminophen.

The latest changes largely beef up and highlight warnings on drug labels. They also would require the more prominent disclosure, using fluorescent or bold-faced type, of the presence of the drugs among a medication's ingredients.

For acetaminophen, the labels would warn of the risk of severe liver damage if patients take more than the recommended dose or consume three or more alcoholic drinks a day while on the drugs. The labels also would warn patients not to take multiple medicines that contain acetaminophen. In any given week, an estimated 48 million Americans take an acetaminophen product.

For aspirin, ibuprofen, naproxen and other nonsteroidal anti-inflammatory drugs, or NSAIDs, their labels would have to contain additional warnings of the risk of stomach bleeding. The labels would note the risk is higher in patients older than 59, or in those who have stomach ulcers, take blood-thinning drugs or steroids, use other drugs that contain an NSAID or remain on the medications for an extended period.

All the affected drugs are available without a prescription and also are used in multiple combination products sold only with a doctor's note.