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Date: Friday, November 14, 1997 FOR IMMEDIATE RELEASE Contact: Food and Drug Administration Susan Cruzan: 301-827-6242 Broadcast Media: 301-827-3434 Consumer Hotline: 800-532-4440
FDA today announced that it intends to require an alcohol warning on all over-the-counter pain relievers, which include aspirin, other salicylates, acetaminophen, ibuprofen, ketoprofen, and naproxen sodium.
The proposal follows an extensive FDA review of data on the effect that consumption of alcoholic beverages can have on users of various OTC analgesics.
The proposed warnings are designed to alert consumers about the specific risks that may be posed by the interaction of heavy alcohol consumption and the use of different types of OTC analgesics.
"Consumption of excessive alcohol while taking pain relievers can be dangerous to your health," said Lead Deputy FDA Commissioner, Michael A. Friedman, M.D.
The proposal includes the following warning statements:
For Acetaminophen-Containing Products -- "Alcohol warning: If you drink three or more alcoholic beverages daily, you should ask your doctor whether you should take [product name] or other pain relievers. [Product name] may increase your risk of liver damage."
For Aspirin, Carbaspirin calcium, Choline salicylate, Ibuprofen, Ketoprofen, Magnesium salicylate, Naproxen sodium and Sodium salicylate-Containing Products -- "Alcohol Warning: If you drink three or more alcoholic beverages daily, ask your doctor whether you should take [product name] or other pain relievers. [Product name] may increase your risk of stomach bleeding."
For Products Containing Combinations of Acetaminophen with other Analgesic/Antipyretic Ingredients Listed in the Code of Federal Regulation Part 21, 201.322 (a) (2) (i.e., combinations of the above analgesic categories) -- "Alcohol warning: If you drink three or more alcoholic beverages daily, ask your doctor whether you should take [product name] or other pain relievers. [Product name] may increase your risk of liver damage and stomach bleeding."
The proposed rule opens up a 90-day comment period, in which the public can respond to the agency's proposal. FDA is asking for comments on the wording of these warnings and the content of the proposed warnings. The comments will be used to develop a final rule, which would go into effect six months after it is published in the Federal Register.
The issue of potentially harmful interactions between pain relievers and alcohol was the focus of a Nonprescription Drugs Advisory Committee meeting on June 29, 1993. At that meeting, the committee concluded that alcohol abusers or heavy drinkers are at increased risk for developing liver toxicity when using acetaminophen. However, committee members were concerned that an alcohol warning on OTC drug products that contain acetaminophen in the absence of a similar warning on other pain reliever products would lead alcohol abusers to switch to products that contain other analgesic ingredients, which might pose equally significant, but different, risks.
On Sept. 8, 1993, the Nonprescription Drugs Advisory Committee met jointly with the Arthritis Drugs Advisory Committee to reconsider this issue and concluded that the use of aspirin, ibuprofen, or naproxen sodium increases the risk of upper gastrointestinal bleeding in heavy alcohol users or abusers and made a formal recommendation for FDA to require an alcohol warning on these OTC pain relievers.
Since that time, FDA has asked for manufacturers to voluntarily include an alcohol warning on their packages while the agency developed formal requirements for such a warning. Although some manufacturers have provided such warnings, the FDA proposal would require a consistent, universal warning. FDA has already required an alcohol warning for the new pain relievers previously marketed as prescription drugs and now available over-the-counter. These include naproxen sodium, the active ingredient in Aleve, and ketoprofen, the active ingredient in Orudis KT and Actron.