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FDA Repeats Acetaminophen Liver Warnings for Rx Drugs


May 1, 2014 — The U.S. Food and Drug Administration (FDA) is reminding doctors and pharmacists that they should no longer prescribe or dispense prescription painkillers containing more than 325-mg of acetaminophen, the active ingredient in Tylenol.

According to the FDA:

“These products were voluntarily withdrawn by the manufacturers at FDA’s request to protect consumers from the risk of severe liver damage, which can result from taking too much acetaminophen.”

The previous FDA Safety Communication was published on January 14, 2014. However, at that time, they recommended that doctors “consider prescribing combination drug products that contain 325 mg or less of acetaminophen.”

Apparently the message was not clear enough, because the FDA is now asking pharmacists not to fill prescriptions for combination painkillers containing more than 325-mg of acetaminophen, and instead contact the prescriber to discuss a lower dose medication. The FDA is also asking wholesalers to remove product codes for products containing more than 325-mg of acetaminophen and return all products to the manufacturers.

In January 2011, the FDA asked manufacturers to voluntarily limit the dose of acetaminophen to 325-mg in prescription painkillers. They also required label updates to warn of the potential risk of severe liver injury.

Despite years of FDA action, accidental acetaminophen overdoses remain a leading cause of liver failure in the United States. The risk of liver damage primarily occurs when patients take multiple products containing acetaminophen within a 24-hour period.

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