FDA Drug Safety Communication

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FDA Date: 1/13/11

FDA Drug Safety Communication for Acetaminophen Products

Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure

FDA is asking drug manufacturers to limit the strength of acetaminophen in prescription drug products, that are predominantly combinations of acetaminophen and opioids. This action will limit the amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients.

In addition, a Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (eg, swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) are being added to the label of all prescription drug products that contain acetaminophen.

These actions will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen.

OTC products containing acetaminophen (eg, Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen-related liver injury from OTC products.

The maximum amount of acetaminophen in a prescription tablet, capsule, or other dosage unit will be limited to 325 mg. However, the total number of tablets or capsules that may be prescribed and the time intervals at which they may be prescribed will not change as a result of the lower amount of acetaminophen. For example, for a product that previously contained 500 mg of acetaminophen with an opioid and was prescribed as 1-2 tablets every 4-6 hours, once reformulated to contain 325 mg of acetaminophen, the dosing instructions can remain unchanged.

Advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day).

View the full FDA Drug Safety Communication on FDA.gov