Pharmaceutical

FDA revokes approval for seven painkillers containing acetaminophen

fda logo FDA revokes approval for seven painkillers containing acetaminophenThe U.S. Food and Drug Administration (FDA) has revoked approval for seven narcotic painkillers containing acetaminophen, including versions of AbbVie Inc.’s Vicodin. The agency has done this in response to recent concerns about these drugs’ potential of causing liver damage.

Just three years earlier, regulators announced a plan to cap the amount of acetaminophen allowed per dose to 325 milligrams. Three versions of Abbvie’s Vicodin that combine acetaminophen and hydrocodone were affected by this.

Also, companies such as Actavis Inc., Nesher Pharmaceuticals USA LLC, West-Ward Pharmaceutical Corp, and Leitner Pharmaceuticals LLC, that all made products containing acetaminophen had those product clearances withdrawn. In the case of prescription drugs that remain on the market with acetaminophen doses of 325 milligrams or less, black-box warnings are required.

Acetaminophen is found in Johnson & Johnson’s product Tylenol with codeine and Percocet, which includes oxycodone. The FDA has been looking at the negative effects of this drug for some time now. There have been many reports of overdosing and adding stress to the liver when acetaminophen is mixed with alcohol.

The agency’s current position is that there are “no data that indicate that taking more than 325 milligrams of acetaminophen per dosage unit provides more pain relief.” Medications with larger doses “do not provide a sufficient margin of safety to protect the public against the serious risk of acetaminophen-induced liver injury,” the FDA wrote in Wednesday’s notice.

Source: www.law360.com