Acetaminophen Linked with Rare, Deadly Skin Conditions: FDA

Acetaminophen can lead to rare but serious skin reactions, The U.S. Food and drug Administration said.

Acetaminophen or Tylenol (one brand name) is an over-the-counter painkiller used to relieve minor aches or fever. The agency said that the drug, used by millions of people in the U.S. could lead to skin rashes in some people.

According to FDA, excessive use of the drug can lead to developing rashes that can cause surface skin damage. It has now advised people who develop these rashes to stop the medication and contact healthcare facility immediately.

The rare skin reactions linked with acetaminophen are Stevens - Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP). Of these three, SJS and TEN can lead to hospitalization and even death while AGEP goes away after the person stops using the drug.

Other non-steroidal anti-inflammatory drugs such as ibuprofen and naproxen are already known to cause skin reactions. Now, drugs containing acetaminophen will have skin-reaction information on the warning label.

"This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications. 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," said Sharon Hertz, M.D., deputy director of FDA's Division of Anesthesia, Analgesia and Addiction.

The warning is based on analysis of data on skin reaction associated with acetaminophen from medical literature and FDA's database called FDA Adverse Event Reporting System (FAERS).

The team found at least 107 cases between 1969 and 2012. Of these cases, over 60 people had to be hospitalized and 12 people died. In all cases, the culprit was acetaminophen-containing drug.

"FDA's actions should be viewed within the context of the millions who, over generations, have benefited from acetaminophen. Nonetheless, given the severity of the risk, it is important for patients and health care providers to be aware of it," Hertz said in a news release.