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FDA Issues New Warnings for Painkillers

Products Containing Acetaminophen, NSAIDs Must Warn of Liver Damage, Stomach Bleeding

Warnings for Patients

The new regulations also require a separate warning instructing consumers to ask their doctors if the stomach bleeding warning applies to them, he says.

The rules also warn patients to stop use of medications if they experience signs of stomach bleeding, which including vomiting blood, feeling faint, having bloody or black stools, or stomach pains that do not get better.

The rules are intended "to reduce the incidence and seriousness of liver damage caused by acetaminophen and stomach bleeding caused by NSAIDs."

Shanthi Sitaraman, MD, a professor of digestive diseases at Emory University School of Medicine in Atlanta, tells WebMD the FDA's action is long overdue.

"Of two major causes of GI bleeding, NSAIDs is No. 1," she says. And NSAIDs can worsen stomach bleeding from other causes, she says. 

Industry Making Changes

Barbara Kochanowski, PhD, and vice president of regulatory affairs for the Consumer Healthcare Products Association (CHPA)in Washington, says its member companies already are "committed to ensuring their medicines' labeling is the most comprehensive and possible.

"CHPA member companies voluntarily have begun implementing many of the label changes included in the final rule ... well ahead of the April 28, 2010, implementation deadline," she says in a news release.

"Our top priority is the safe and effective use of our products, and we will continue to work with the U.S. Food and Drug Administration to ensure that consumers have the information they need on drug facts labels and elsewhere to get the most benefit from OTC medicines."

Charles Ganley, MD, director of the FDA's office of new drugs, says changes in package warnings generally takes at least six months.

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