FDA Warns of Acetaminophen Risk, Adding to Tylenol Concerns

More than ninety lawsuits have been filed against the maker of Tylenol, McNeill-PPC Inc., alleging that the drug can lead to liver failure due to an oversode of acetaminophen. Patients who have suffered liver damage after taking the drug claim that the company failed to properly warn consumers about the dangers of acetaminophen, overstating Tylenol’s safety and producing a drug that was far more dangerous than similar products. In April 2013, the suits were consolidated to a single Pennsylvania court where they will all be heard together in a multidistrict litigation.

Many consumers are often unaware that many products contain acetaminophen.

The suits claim that Tylenol is a far more dangerous drug than the public has been led to believe, and that liver failure can occur when a certain amount of the drug is metabolized by the liver into a toxic by-product. If this toxin builds up it can become extremely hazardous – yet, patients claim, McNeill-PPC Inc. failed to properly warn medical professionals or consumers about this risk, despite allegedly knowing about it. CNN released an interesting report last week highlighting some pretty common misconceptions about acetaminophen, Tylenol, and how effective the medicine truly is – as well as its proper uses.

The FDA itself has been aware of acetaminophen’s potential risks for some time, and in 2011 issued a new order that all drugs containing the medicine must carry warnings about the possibility of liver damage. The agency also mandated a 325mg limit per tablet in an apparent attempt to prevent accidental overdosing. In many cases, patients who take Tylenol on top of their prescription medication may not even realize they’re taking more acetaminophen than advised. The FDA’s limit on the amount per tablet would, it was hoped, go some way to combating accidental self medication.

Last week, the FDA issued another order, recommending doctors and medical professionals no longer prescribe or dispense any combination of drugs that exceeds the 325mg limit in a single dosage. On top of the known risk, the agency said in a statement that there’s simply no proof that taking more than 325mg of acetaminophen provides any additional benefit to patients. It can, however, contribute to serious health problems such as liver failure.

The agency’s initial 2011 order requested that drug companies comply with the agency’s new recommendation before January 14, 2014. More than half of the companies affected by the new rules voluntarily complied with this request – as you would expect. Some, however, seem not yet to have given the agency any assurance that they’ll do so. Unwilling to play around, the FDA has stated that it will withdraw approval for any prescription drugs from manufacturers who haven’t made the changes, rendering the medications illegal. With that kind of sway, it’s only a matter of time before prescriptions with more than 325mg of acetaminophen become a thing of the past.

The FDA has stated that its prime reason for the new restrictions is a desire to “protect consumers from the risk of severe liver damage” related to acetaminophen overdoses. More than 500 deaths a year have been linked to acetaminophen, making this a very real risk, and the FDA’s direct addressing of the problem may even be overdue. The next step, though, is to raise public awareness. After all, the FDA itself admits that “many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.”

Easy, perhaps, but still potentially fatal.

The FDA’s notice currently applies only to prescription drugs, although over-the-counter acetaminophen products will be addressed in the near future, the agency has said. You can be sure that Tylenol will be affected by any of the agency’s recommendations for over-the-counter drugs – Tylenol Extra Strength gel tablets currently contain 500 mg of acetaminophen per dose, providing a clear conflict with the FDA’s increasingly cautious approach to the drug. As the lawsuits continue and the FDA turns its attention more and more to acceptable dosage amounts, acetaminophen – and Tylenol by association – could become a far less common medication.

That, in the end, may well be a good thing.