Acetaminophen Liver Warning Reissued, Extra Strength Tylenol Unaddressed

Federal drug regulators have issued a reminder to doctors and pharmacists to stop giving out prescription drugs that contain more than 325 milligrams of acetaminophen, due to the risks of liver damage. However, the warning raises further questions about why Extra Strength Tylenol, which is sold over-the-counter, remains available with 500 milligrams 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.

On April 28, the agency issued a reminder for health care providers, and asked pharmacists to remove high-dose acetamonophen from their inventories. However, the agency still has not taken similar steps to address the liver failure risks with Extra Strength Tylenol.

Acetaminophen is the active pharmaceutical ingredient in Tylenol and a number of other combination pain killers. Despite the widespread belief that Tylenol and acetaminophen pain medications 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. However, the warning does not address Extra Strength Tylenol and other over-the-counter medications that contain high levels of acetaminophen.

“If a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit, FDA recommends that they contact the prescriber to discuss a product with a lower dose of acetaminophen,” according to the FDA reminder issued April 28. “These products are no longer considered safe by FDA and have been voluntarily withdrawn. We encourage pharmacists to return them to the wholesaler or manufacturer.”

Tylenol Liver Failure Concerns

Critics have warned that while the FDA has taken steps to make sure doctors and pharmacists are aware of the potential liver risks with high-dose acetaminophen products, many consumers continue to believe Tylenol and other over-the-counter products are safe. This could result in consumers suffering catastrophic liver injuries from taking too much Tylenol or combining over-the-counter drugs that contain acetaminophen.

In recent years, increased effort has been focused on raising public awareness about the risk of acetaminophen overdose, but Extra Strength Tylenol and other high-dose products remain available over-the-counter. Given the narrow margin between the recommended dose and a risk of liver failure, critics continue to call for stronger regulatory actions.

The FDA first began telling drug manufacturers to remove high-acetaminophen combination painkillers from the market in January 2011. Some combination drugs that contained more than 325 mg of acetaminophen, like Lorcet 10/650, which had 650 mg of acetaminophen, have already been discontinued. According to the FDA, more than half of manufacturers have already voluntarily removed high-acetaminophen combination drugs from the market, but some still remain available.

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.