Earlier this month, the U.S. Food and Drug Administration (FDA) issued a warning regarding the risks of rare and potentially fatal skin reactions linked to the acetaminophen found in brand-name Tylenol and other over-the-counter (OTC) pain relievers. The FDA discovered a link between acetaminophen found in the popular pain reliever to Steven-Johnson Syndrome and toxic epidermal necrolysis (TEN). Both serious skin reactions require hospitalization and, if left untreated, can be fatal.

According to the FDA, the rare skin reactions cause the acetaminophen user to develop rashes, blisters, and extensive skin damage. Anyone that develops a rash or skin reaction while taking Tylenol is encouraged to immediately stop taking the medication and seek medical attention. Flu-like symptoms, rash, and other skin symptoms while taking Tylenol are usually the first signs of a possible reaction.

The FDA requested the skin reaction warning be added to the labels of Tylenol and other acetaminophen products after data analysis of its Adverse Event Reporting System database (FAERS) and american literature revealed 107 involving acetaminophen-related skin reactions that occurred from 1969 to 2012. The FAERS analysis discovered that most of the cases occurred with acetaminophen users, and included 67 hospitalizations and 12 deaths.

Other OTC pain relievers, such as naproxen sodium and Ibuprofen, have already been updated to add the skin reaction warning to their labels.

“For decades, there has been a possible link between the acetaminophen found in Tylenol to serious health complications. However, the manufacturer of Tylenol inadequately warned of the risks until they were forced to do so by the FDA,” commented Megan McBride, a Product Liability and Tylenol lawyer with the Levin, Papantonio law firm. “Unfortunately, it takes consumer injury and death and FDA action to push these companies to disclose the risks of their products. The known skin reaction risks associated with Tylenol should have been revealed to consumers from the start.”

Acetaminophen has been a commonly-used active ingredient in OTC drugs for years. The ingredient is usually found in drugs used to treat mild pain, colds, coughs, allergies, headaches, and trouble sleeping.

Krysta Loera is a writer and researcher for Ring of Fire.