FDA Launches Campaign on OTC Pain Relief Products

In January 2004, the FDA launched a national education campaign on the safe use of over-the-counter pain relief products.

"Pain relievers and fever reducers are safe drugs when used as directed, but they can cause serious problems when used by people with certain conditions or those who are taking specific medicines," says FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We want to remind consumers who take these products that it's important to follow current dosing and label directions carefully."

The FDA's campaign focuses on OTC pain and fever reducers that contain acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs), which include products such as aspirin, ibuprofen, naproxen sodium and ketoprofen.

Many OTC medicines sold for different uses have the same active ingredient. For example, a cold-and-cough remedy may have the same active ingredient as a headache remedy or a prescription pain reliever. To minimize the risks of an accidental overdose, consumers should avoid taking multiple medications with the same active ingredient at the same time.

Acetaminophen is an active ingredient found in more than 600 OTC and prescription medicines, such as pain relievers, cough suppressants and cold medications. It is safe and effective when used correctly, but taking too much can lead to liver damage and even death. The risk for liver damage may be increased in people who drink three or more alcoholic beverages per day while using acetaminophen-containing medicines.

NSAIDs are common medications that are used to relieve fever and minor aches and pains. These products can cause stomach bleeding, with an increased risk in consumers who are over 60, are taking prescription blood thinners, are taking steroids, or have a history of stomach bleeding. NSAIDs may also increase the risk of kidney problems in people with pre-existing kidney disease, or who are taking a diuretic.

In September 2002, the FDA's Non-Prescription Drugs Advisory Committee recommended changes to labeling of certain OTC drug products, including acetaminophen and NSAIDs. They advised that these changes are needed to better inform consumers about the products' ingredients and the possible side effects caused by improper use. The FDA is reviewing various labeling changes that better reflect the latest scientific knowledge about oral OTC pain relievers.

The FDA recommends that consumers talk with health care providers or pharmacists if they have questions about using OTC medicines, and especially before using them in combination with dietary supplements or other OTC or prescription medicines.

The FDA's educational campaign will provide advice on how to avoid taking more than the recommended doses of pain medicines and will raise awareness of the underlying health conditions that increase risk. The campaign will include:

• an OTC pain reliever brochure to be distributed in pharmacies and by health care providers
• a newspaper article to be distributed to 10,000 community papers across the country
• a reprint of an FDA Consumer article called "Use Caution with Pain Relievers" that will be distributed at national health conferences and made available for reprinting in health publications
• two print public service ads that will be sent to about 100 major magazines. All of these materials are available on the FDA's Web site at www.fda.gov/cder/drug/analgesics/.