HHS NEWS

P98-31                          FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE           Susan M. Cruzan:     301-827-6242
October 21, 1998                
                                Consumer Inquiries:  800-532-4440

FDA ANNOUNCES NEW ALCOHOL WARNINGS FOR PAIN RELIEVERS AND FEVER REDUCERS

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:

• Acetaminophen: "Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage."
• Aspirin, carbaspirin calcium, choline salicylate, ibuprofen, ketoprofen, magnesium salicylate, naproxen sodium and sodium salicylate: "Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take [ingredient] or other pain relievers/fever reducers. [Ingredient] may cause stomach bleeding."
• Combination of acetaminophen with other analgesic/antipyretic ingredients: "Alcohol Warning" "If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take [insert ingredients] or other pain relievers/fever reducers. [Insert ingredients] may cause liver damage and stomach bleeding.

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.