FDA Warns Consumers About Rare Serious Skin Reactions Caused by Acetaminophen

A latest consumer update by the U.S. Food and Drug Administration warns consumers that  acetaminophen carries the risk of serious skin reactions.

According to the report, FDA warns consumers that acetaminophen, which is widely used in the U.S. as a fever and pain reliever, can cause rare but serious skin reactions.

The three types of skin diseases include, Stevens-Johnson Syndrome (SJS) , toxic epidermal necrolysis (TEN) that generally demand immediate hospitalization and in worst cases leads to the death and acute generalized exanthematous pustulosis (AGEP) that subsides within two weeks of discontinuing the medicine.

According to FDA, if patients taking acetaminophen develop any sort of skin reactions, they should immediately discontinue the medicine and seek medical treatment at the earliest.

"This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications," says Sharon Hertz, M.D., deputy director of FDA's Division of Anesthesia, Analgesia and Addiction. "However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal."

Other drugs such as ibuprofen and naproxen that are used to treat fever and pain already carry the warning label regarding the risk of serious skin reactions. The active ingredient ibuprofen is included in drugs like Advil and Motrin. And naproxen is included in drugs like Aleve and Midol.

Acetaminophen has been used by millions of people over several decades and it is the generic name of the active ingredient that is used in several prescribed and non prescribed medicines. And one such brand name is Tylenol. In 2011 J&J reduced the maximum dose for Tylenol to lower the risk of overdose and damage caused to the liver by intake of excess acetaminophen.

FDA concluded the risk of skin reaction followed by acetaminophen intake after reviewing the FDA Adverse Event Reporting System (FAERS) database. They noticed that from 1969-2012 there were 107 cases that reported skin reactions out of which 67 hospitalization and 12 deaths occurred.

FDA plans on working with the manufacturers to include warning label on all the over the counter drugs that contain acetaminophen.