FDA Limits Acetaminophen in Combo Prescription Products

Sets 325 mg maximum in order to lower risk of liver toxicity; also requesting boxed warning

THURSDAY, Jan. 13 (HealthDay News) -- The U.S. Food and Drug Administration is requesting that manufacturers of prescription combination products containing acetaminophen limit the amount of acetaminophen to a maximum of 325 mg in each tablet or capsule to reduce the risk of liver toxicity. In addition, the agency is directing manufacturers to update labels of all prescription combination products to warn consumers of the possible risk for severe liver injury.

Combination prescription products that contain acetaminophen may also contain codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin). According to the FDA, the risk of severe liver injury appears to be highest among those who take more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, take more than one acetaminophen-containing product at the same time, or consume alcohol while taking acetaminophen products. The current maximum dose is 4,000 mg within 24 hours.

Over the next three years, higher dose prescription products containing acetaminophen will be phased out, but this poses no threat of a shortage of pain medication, according to the FDA. The FDA is also proposing a boxed warning to be added to the label of acetaminophen prescription products. Acetaminophen is also available over-the-counter (OTC) alone or in combination with other OTC ingredients, such as cough and cold ingredients. The FDA action regarding prescription acetaminophen products is not intended to impact the use of OTC acetaminophen products.

"There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider," Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research, said in a statement.

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