FDA Restricts Acetaminophen in Prescription Painkillers

The amount of acetaminophen found in prescription painkillers like Vicodin and Percocet presents a serious risk of liver damage for patients who take too much of these medications, and the U.S. Food and Drug Administration (FDA) is taking action. The agency is ordering manufacturers of these drugs to limit the per-pill level of acetaminophen to 325 milligrams, which is the same amount of acetaminophen that can be found in one regular-strength Tylenol pill, available over the counter. The new restrictions apply to a number of popular prescription painkillers -- including Vicodin and Percocet, and their generic versions -- which may contain as much as 700 milligrams of acetaminophen per dose.

Patients who are prescribed these drugs (often in the short term as part of recovery from an injury or medical procedure) put themselves at serious health risk if they take too much at once, because an overdose of acetaminophen can cause severe liver damage. According to the FDA, the greatest danger to patients occurs when they take more than the prescribed dose of acetaminophen, take more than one acetaminophen-containing product at once (e.g. combine prescription and over-the-counter drugs), or when patients drink alcohol while taking acetaminophen. The dangers presented by overdose of acetaminophen have been under the microscope for some time, since liver failure caused by acetaminophen accounts for about 400 deaths each year in the United States. In 2009, after looking at the dangers of acetaminophen-combination prescription drugs, an FDA advisory panel recommended that Vicodin and similar drugs be removed from the market altogether.

As part of the new restrictions on acetaminophen-combination painkillers (the changes will be implemented over the next three years), the FDA is also requiring manufacturers of these drugs to include a black box warning label on packaging materials advising patients of the risk of severe liver injury associated with the medications.

For everything you need to know about acetaminophen and the new FDA restrictions, visit the FDA website at www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htm. And to learn more about legal issues related to drug safety, check out Nolo's articles Product Liability Claims Involving Pharmaceutical Drugs and FDA Drug Recalls.