Label Changes Coming for OTC Pain, Fever Medications

The FDA has issued a final rule (25-page PDF; About PDFs) in the April 29 Federal Register that requires manufacturers of OTC pain relievers and fever reducers to include organ-specific warnings about potential safety risks on the medications' labels.

The new labeling requirements will take effect within a year and are designed to inform consumers about the risk of severe liver damage when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs, or NSAIDs, such as aspirin, ibuprofen, naproxen and ketoprofen.

"Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches," said Charles Ganley, M.D., director of the FDA's Office of Nonprescription Products in the Center for Drug Evaluation and Research, in an April 28 news release. "However, the risks associated with their use need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk."

Manufacturers also must ensure that the active ingredients of the drugs are displayed prominently on drug labels appearing on both the packaging and individual medication bottles.

The FDA said some manufacturers started voluntarily revising product labeling in 2006 to identify these safety issues. However, the voluntary changes did not address all of the requirements in the new rule.

Labeling changes are necessary, said the FDA, because consumers sometimes take more than the recommended amount of acetaminophen, and others unknowingly take multiple products containing acetaminophen at the same time. Exceeding the recommended dosage of acetaminophen may increase the risk for severe liver damage.

The agency said in its final rule that accidental overdose of acetaminophen is associated with thousands of emergency room visits and hospital admissions and an estimated 100 deaths each year.

Meanwhile, stomach bleeding risks increase for people who take multiple NSAIDs concurrently or for longer periods than directed. New labeling also will point out the higher risk for stomach bleeding in people who use NSAIDs in combination with anticoagulants or steroids. The risk for organ damage also is increased when people use alcohol while taking acetaminophen or NSAIDs.

The FDA has scheduled an advisory committee meeting June 29-30 to discuss additional steps the agency might take to reduce the risk of liver damage associated with acetaminophen overdoses.