October 21, 1998

The Food and Drug Administration announced today that all over-the-counter (OTC) pain relievers and fever reducers must carry a warning label advising people who consume three or more alcoholic drinks every day to consult their doctors before using these drugs.

This announcement is based on a final rule, which is on display today in the Federal Register, requiring manufacturers to add this warning to the labeling within six months for OTC products and combination products intended for adult use that contain aspirin, other salicylates, acetaminophen, ibuprofen, naproxen sodium, or ketoprofen.

FDA is issuing this final rule after considering public comments and data on the effect of combining chronic alcohol ingestion and the use of various OTC analgesics. The action also follows the recommendations of the Nonprescription Drugs Advisory Committee and the Arthritis Drugs Advisory Committee which concluded that chronic alcohol users should be warned that they may be at an increased risk of liver damage or stomach bleeding from use of these drugs.

Today's comprehensive action provides for an alcohol warning on all OTC pain relievers and fever reducers intended for adult use and may help prevent serious side effects in people who consume three or more alcoholic drinks every day.

The specific warnings concerning "liver damage" and "stomach bleeding" are being required because the agency believes that consumers with a history of chronic alcohol use need to know the potential risk that use of OTC analgesic and antipyretic (fever reducing) drug products may pose to them.

"Consumers need to know that chronic use of alcohol while taking pain relievers or fever reducers can be hazardous to their health. FDA urges people with a history of alcohol use to seek a doctor's advice about their risk of side effects before taking these medications," said Dr. Michael A. Friedman, Acting FDA Commissioner.

FDA's final rule, includes the following specific warnings:

According to the Substance Abuse and Mental Health Service Administration report, "Preliminary Results from the l997 National Household Survey on Drug Abuse," about 11 million Americans are heavy drinkers. These people, therefore, are at risk of the serious side effects that may be posed by the combination of heavy alcohol use and analgesics or antipyretics labeled for OTC adult use.

New OTC pain relievers and fever reducers approved for OTC adult use since 1993 have already been required to carry a warning for heavy alcohol users. However, labeling to indicate the specific risk associated with each ingredient has not been required. Products previously required to include an alcohol warning in their labeling include Aleve (naproxyn sodium), Orudis KT and Actron (ketoprofen), Advil Liquigels (solubilized ibuprofen), and Tylenol Extended Release (acetominophen). These products will also be subject to the new rule.

They say one in five people with the condition are at risk of having a severe reaction to the drug - twice as many as had been estimated.

But the researchers, writing in the British Medical Journal, say many patients are unaware of the risk.

They warn other NSAIDs - non steroidal anti-inflammatory drugs- including ibuprofen, can also cause an attack.

UK and Australian researchers looked at 21 studies of asthmatic patients, and found 21% of adults and 5% of children experienced a reaction to aspirin, which is also found in many headache and cold remedies.

"It is essential that both family doctors and the public are aware of this risk"; Dr Simon Fradd, Developing Patient Partnerships.

Around 10 million people are estimated to have asthma in the UK, meaning around two million could be sensitive to aspirin and be at risk of suffering a potentially life-threatening reaction to aspirin. They said many would also be sensitive to the other NSAIDs.

The researchers said the growing trend for patients to buy over-the-counter painkillers meant it was important to raise awareness of the potential risks for asthmatics.

They called for warnings to be added to packaging for painkillers to warn asthmatics of the dangers.

They also advised patients to choose paracetamol after finding only 7% of adult asthma patients were sensitive to it.

Dr John Costello, clinical director of medicine at King's College Hospital in London, told BBC News Online warnings on aspirin and NSAID packets would help asthmatics. "There are lots of companies who make these compounds and I think it would take legislation to get warning labels put on packets so people are aware that if they have asthma and are sensitive to aspirin they should not take it."

He added doctors also had to be more aware aspirin could trigger asthma, and should advise patients accordingly. "It may be that people go to the doctor and say their asthma has been playing up but the doctors are not asking the right questions about what they have been doing which might have triggered it. "They need to think about asking whether the patient has taken aspirin and if it may have provoked their symptoms."

A spokeswoman for the National Asthma Campaign said most people with asthma could take painkillers safely. But she added some people may have adverse reactions. "Just one tablet of aspirin may bring a severe, life-threatening attack of asthma."

She added: "When buying medicines such as cold relievers from a shop with no pharmacist, check if aspirin is listed in the small print on the back of the packet.

Dr Simon Fradd, chairman of the charity Developing Patient Partnerships, said the association between asthma and taking aspirin was well known. But he added: "This paper makes it clear that that association is much wider, including all non steroidal anti-inflammatory drugs. "It is essential that both family doctors and the public are aware of this risk."