Acetaminophen Liver Risks Result in Revoked Approval for Pain Meds

In a long-expected move, the FDA has revoked approval for generic versions of Vicodin, Percocet and other prescription combination pain medications that included large amounts of acetaminophen, which has been linked to an increased risk of liver damage. 

The move is the latest round of approval withdrawals for combination painkillers that contain 325 milligrams of acetaminophen or more. However, the FDA has not made similar moves against over-the-counter drugs that contain high amounts of the ubiquitous painkiller, such as Extra Strength Tylenol, which contains 500 milligrams in each tablet.

The FDA published a notice of the approval withdrawals in the federal register on Thursday, revoking approval for AbbVie’s generic version of Vicodin (acetaminophen and hyydrocodone), Vicodin ES, and Vicodin HP, Leitner Pharmaceuticals’ Synalgos-DC-A, generic  versions of Vicodin by Nesher Pharmaceuticals and Watson Laboratories, and Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate by West-Ward Pharmaceutical Corp.

Abbott Laboratories held the original trademark for Vicodin, but spin-off company AbbVie acquired the name and used it with generic versions of the drug.

The FDA began removing the drugs from the market due to the liver risks with acetaminophen and the relatively small benefits obtained by patients.

Despite the widespread belief that Tylenol and acetaminophen-based pain meds are safe, acetaminophen overdose has been identified as a leading cause of liver failure in the United States, causing thousands of hospitalizations and hundreds of deaths each year.

The FDA indicates that acetaminophen medications prescribed in large doses can cause serious liver damage and indicate that it is unclear if patients obtain any benefit from combination drugs that contain more than 325 milligrams of acetaminophen in each tablet.

The FDA first issued the acetaminophen liver warning on January 14, recommending that doctors and pharmacists discontinue prescribing and dispensing combination acetaminophen pain killers.

In March, the agency published a federal register notice for 108 such products whose distributors had voluntarily requested their approval applications be withdrawn. The latest round of withdrawals were not voluntary, but the FDA noted that the holders of the approvals waived their opportunity for a hearing.

In response to the concerns, Johnson & Johnson lowered the maximum recommended dosage on Extra Strength Tylenol and other acetaminophen-based products from 4,000 mg per day to 3,000 mg per day in 2011, after the FDA announced the new limits on acetaminophen levels in prescription painkillers like Vicodin and Percocet. However, the drug maker continues to maintain that Tylenol is a safe and effective, and few consumers realize the risk of liver damage that may be caused by taking more than two pills with each dose or failing to carefully monitor the frequency of doses.

Johnson & Johnson currently faces a number of Tylenol lawsuits filed in state and federal courts throughout the country on behalf of former users who suffered liver damage, liver failure or death. The complaints allege that Johnson & Johnson has built the global impression that Tylenol is safe by withholding information about the potential risks associated with acetaminophen for decades. Many of the complaints suggest that the FDA would never approve Tylenol as an over-the-counter medication if it were first introduced today.