|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
October 21, 1998
ANNOUNCES NEW ALCOHOL WARNINGS FOR PAIN RELIEVERS AND FEVER REDUCERS
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
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
"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.