FDA Warns About Link between SJS and Acetaminophen

September 1, 2013, 8:00AM. By Heidi Turner

Washington, DCThe US Food and Drug Administration (FDA) has issued a warning about the risk of Stevens Johnson syndrome linked to acetaminophen. The concern is serious enough that the FDA has requested the makers of acetaminophen products strengthen their warnings about Stevens Johnson syndrome skin disease. The agency has also issued a warning about Stevens Johnson syndrome symptoms, noting that patients who develop symptoms of the skin disease should stop taking the product and seek medical attention.

The warning came after the FDA reviewed medical literature and the FDA Adverse Event Reporting System. The Adverse Event Reporting System uncovered 107 cases of adverse skin reactions between 1969 and 2012 linked to acetaminophen. Of those, 67 patients were hospitalized and 12 died. Meanwhile, medical literature showed approximately 24 cases of adverse skin reactions.

According to the FDA warning, acetaminophen has been linked to Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN, a more severe form of SJS). Both are allergic reactions to medications. They are potentially fatal conditions that usually require hospitalization and often involve long recovery times and a risk of permanent injury.

“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, MD, deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction.

Acetaminophen is a pain reliever - also used to treat fever - that has been linked to an increased risk of Stevens Johnson syndrome. Patients can develop SJS or TEN even if they have previously tolerated the medication, which is sold both over the counter and in prescription formulations. The FDA has requested that the makers of prescription acetaminophen medications strengthen the warnings to include SJS and TEN, while the agency will also work with manufacturers to include a warning on over-the-counter formulations.

The FDA notes that SJS and TEN are rare, but patients who develop the rash, blisters or skin damage should seek medical attention immediately. Patients who have previously had a skin reaction when taking an acetaminophen product should use different medication. The agency notes that the benefits of acetaminophen are still seen to outweigh the risks, but patients should be aware of the potential for serious reactions.