FDA limits amount of acetaminophen in prescription drugs

SILVER SPRING, Md. — The Food and Drug Administration is capping the amount of the painkiller acetaminophen in prescription drugs due to the risk of liver toxicity, the agency said Thursday.

The FDA asked manufacturers of prescription drugs that contain the drug to limit it to 325 mg per tablet. The policy will be phased in over three years but does not affect over-the-counter products containing the drug, such as Johnson & Johnson’s Tylenol and Procter & Gamble’s NyQuil. The drug often appears in prescription painkillers, such as Endo Pharmaceuticals’ Percocet (oxycodone and acetaminophen) and Abbott’s Vicodin (hydrocodone and acetaminophen).

Overdoses from prescription painkillers combining acetaminophen with another ingredient account for nearly half of all cases of acetaminophen-related liver failure, which often result in liver transplant or death, according to the FDA. The risk usually is increased when patients take multiple drugs containing acetaminophen at once and exceed the current maximum dose of 4,000 mg within a 24-hour period.

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