The Agency is announcing today:

In September 2002 FDA’s Non-Prescription Advisory Committee (NDAC) held a public meeting to review the safety and labeling of certain OTC drug products such as acetaminophen, aspirin, and nonsteroidal anti-inflammatory drug (NSAIDs). Specifically, the committee reviewed cases of severe liver injury associated with the use of acetaminophen. They also reviewed cases of stomach bleeding and kidney injury related to the use of aspirin and NSAIDs. The committee recommended changes to the labels of these products to better inform consumers about the ingredients in the products and possible serious side effects with improper use. NDAC also recommended that FDA take a more active role in the education of consumers and health providers about the safe use of these products.

You can take these medications safely by carefully reading the directions and by understanding what drugs are in the products you take. People can take too much acetaminophen either by not following directions or by taking products at the same time that both contain acetaminophen. Be sure and read the directions.

For NSAIDs, carefully read the label and make sure you do not have a health condition that would increase your risk. Aspirin and other NSAIDs can cause stomach bleeding. Although it is rare for these events to occur when using OTC doses and for short periods of time, some people do develop bleeding. You have an increased risk if you:

• have a previous history of stomach bleeding,

• are over the age of 60,

• drink three or more alcoholic drinks a day,

• take steroid medications, or take other NSAID medications.

Nonsteroidal anti-inflammatory drugs are often referred to as NSAIDs. This is a group of drugs that include products such as ibuprofen, naproxen and aspirin. NSAIDs are taken to reduce minor aches and pains, headaches and fevers.

Pain reliever and fever reducer drug products have been available for many years without a prescription. These products are safe and effective when used by consumers properly. The FDA believes that consumers need to know that pain relievers or fever reducers can cause serious side effects when used improperly. FDA urges people to read the labels of all the OTC medicines they take to know how to take them properly.

You can find out more information by reading the FDA Consumer article "Use Caution with Pain Relievers". You can also ask your pharmacist or healthcare provider if you have questions about using OTC medicines with your prescription medicines.