FDA Seeks to Limit Acetaminophen Strength in Prescription Drugs

On January 13, the Food and Drug Administration (FDA) notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drugs to 325 mg per tablet, capsule or other dosage unit. According to the FDA, this action was taken to help curtail the severe liver damage and allergic reactions that can be caused by acetaminophen.

A boxed warning will also be added to the label of any prescription drug product that contains acetaminophen.

Acetaminophen is commonly used in both prescription and over-the-counter (OTC) medications to reduce pain and fever. OTC medications are not affected by this action because information regarding the potential for liver damage is already required to be on the labels for OTC medications containing acetaminophen.

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