FDA Committees Wary of OTC Analgesic-Antacid Products as Hangover Remedy

FDA Committees Wary of OTC Analgesic-Antacid Products as Hangover Remedy

Two FDA advisory committees have suggested that over-the-counter products that contain both a pain reliever and an antacid should not be indicated as a treatment for hangovers due to side effect concerns.

By a 15-5 vote, members at a joint meeting of the FDA’s Nonprescription Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee decided that using combination OTC analgesic-antacid products is not “rational” to relieve minor aches and pains associated with heartburn, sour stomach, gas or nausea.

A 1991 ruling allows manufacturers to sell such combination products for several indications, including “upset stomach associated with hangover.”

OTC analgesic-antacid drugs are widely available but have been plagued by side effects. In June 2016, the FDA issued a warning about a risk of serious bleeding with aspirin-antacid combination products after receiving 8 adverse event reports related to these products, which are sold under names including Alka-Seltzer and Bromo Seltzer.

Some committee members also expressed concern about using products containing aspirin or Tylenol (acetaminophen) to treat a hangover, considering both drugs can cause problems when used with alcohol. Besides the risk of internal bleeding with alcohol and aspirin, mixing acetaminophen and alcohol is linked to liver toxicity.


Jonathan Block

Jonathan Block

Jonathan Block is an associate editor at BioCentury, which provides news and information about the biotechnology and pharmaceutical industries. Prior to joining BioCentury in 2019, Jonathan worked for MedShadow as content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.


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