Acetaminophen Allowed in Prescription Painkillers Lowered to Prevent Liver Injury

The amount of <"">acetaminophen in prescription painkillers will be limited to 325 mg, according to the U.S. Food & Drug Administration (FDA). In announcing the new acetaminophen limit for drugs like Vicodin, Percocet, Tylenol with Codeine, and Oxycodone, the agency cited the risk of serious liver damage from excessive exposure to acetaminophen.

The FDA will also be mandating that such prescription combination acetaminophen products include “black box” warnings on their labels alerting users to the potential for liver damage.

An FDA advisory committee discussed the issue at a meeting in June 2009, and recommended strengthening the warning about severe liver injury on the drug labels of prescription products containing acetaminophen.

Right now, such prescription painkillers can contain up to 750 mg of acetaminophen. The new 325 mg limit will be phased-in over a three-year period, the FDA said.

Acetaminophen is widely used in both prescription and over-the-counter (OTC) products to reduce pain and fever. It is one of the most commonly-used drugs in the U.S. The actions the FDA is taking for prescription acetaminophen products do not affect OTC acetaminophen products.

According to the FDA, roughly 800 cases of acetaminophen liver injury occur in the U.S. every year. Overdoses from prescription acetaminophen-combination products account for nearly half of all cases of acetaminophen-related liver damage in the U.S. In many instances, these overdoses have fatal outcomes.

Many of these injuries occur because a person is taking two acetaminophen products at one time, and this can exceed the recommended daily limit. Many patients may not know that the drug they’re taking contains acetaminophen and often they aren’t warned to avoid other acetaminophen-containing products.

The FDA is encouraging patients to:

• Carefully read all labels for prescription and OTC medications and ask if their prescription medicine contains acetaminophen.

• Don’t take more than one acetaminophen-containing product at one time and that includes OTC medications.

• Don’t take more than the maximum daily amount of 4 grams, or 4,000 milligrams, of acetaminophen a day.

• Avoid drinking alcohol while taking acetaminophen.

• Stop taking acetaminophen and seek medical help immediately if you experience allergic reactions such as rash, itching, swelling of the face and/or difficulty breathing.

• Seek medical help right away if you think you have taken more than the directed dosage of acetaminophen.

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