E-DRUG: New Alcohol Warnings for Pain/Fever Meds
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October 21, 1998
FDA ANNOUNCES NEW ALCOHOL WARNINGS FOR PAIN RELIEVERS AND FEVER REDUCERS
The U.S. 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:
�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.
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