Ibuprofen & Stevens Johnson Syndrome

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February 15th, 2005

"Group petitions for ibuprofen warning"

Most people have never heard of Stevens Johnson Syndrome, and that is probably because it only occurs in about five in one million users. A group of doctors and families are now calling on federal regulators to warn the public about this potentially fatal skin reaction.

Stevens Johnson Syndrome will typically appear within a week of taking a new drug. Symptoms include rashes, blisters, red splotches on the skin, blisters in mucous membranes, swelling of eyelids, red eyes, persistent fever, flu like symptoms, conjunctivitis and other effects. If continuing to take the drug, the condition will continue to worsen, attacking the skin and mucous membranes and resembling severe burn injures all over the body.

The petition filed with the FDA is asking the agency to order label warnings on products containing ibuprofen, such as brand name Advil and Motrin. The warnings would highlight the risk of the disorders and urge consumers to immediately stop the drug’s use if a rash appears. It also asked the FDA to launch an investigation to see if ibuprofen manufacturers withheld critical safety data regarding over-the-counter forms of the drug.

Motrin maker McNeil Consumer & Specialty Products issued a statement stressing the rarity of Stevens Johnson Syndrome and that the skin disease is caused not just by ibuprofen. According to a toxicologist from Baylor University Medical Center in Dallas, who also signed the petition, “All we’re asking for is a few sentences on the box. We’re not asking that the drug be ‘withdrawn’ from the market.”

Stevens Johnson Syndrome can be caused by other medications, but the petitioners say few U.S. doctors and almost no consumers are aware of the ibuprofen risk.