Lawsuit Claims Motrin Maker Failed to Warn on Stevens Johnson Syndrome

Beleaguered drug giant, Johnson & Johnson, is making headlines yet again. This time, Bloomberg News reports that the drug maker is accused of neglecting to warn parents that its Children’s Motrin and Tylenol can cause a potentially deadly skin reaction that can lead to blindness, burns, disfigurement, and death.

<"">Stevens Johnson Syndrome (SJS) is a severe sensitivity reaction that presents with blistering of mucous membranes, typically in the mouth, eyes, and vagina and patchy areas of rash that eventually peel off the skin. SJS can even spread to internal organs, causing scarring and even blindness. The most severe cases of SJS are referred to as TEN (toxic epidermal necrolysis) and involve over 30 percent of the body surface being covered in blisters. Both SJS and TEN usually require treatment in hospital burn units.

SJS can be caused by just about any drug, but is most often associated with anticonvulsants, antibiotics like penicillin and sulfonamides, and common anti-inflammatory drugs like aspirin; naproxen; and ibuprofen products, such as Motrin and Tylenol.

The key to stopping SJS is early diagnosis and intervention, which includes stopping the drug that has caused the conditions. But because warnings on so many medications are vague, most people wouldn’t recognize that SJS has developed at the earliest stages. They may very well brush off what seems like a minor blister or rash, even though such an occurrence is a major red flag.

According to a recent lawsuit, officials at Johnson & Johnson possessed studies that showed links between Motrin and SJS, but never put warnings on the Motrin labeling, said Bloomberg. In a very recent case, a 3 ½-year-old girl, who is now 13, was left blind in one eye and developed burns over most of her body—84 percent—after taking Motrin and Tylenol, wrote Bloomberg. This is not the first time that Johnson & Johnson and its McNeil unit have been sued over its pain relievers’ connection to SJS. Two other jury trials have been filed with claims that include that Johnson & Johnson and McNeil hid the drugs’ links to SJS, said Bloomberg News.

The companies have since included warnings on the medications that state that the main drug ingredient, ibuprofen, could lead to “a severe allergic reaction,” according to court filings, quoted Bloomberg News. According to the current lawsuit, Johnson & Johnson had the research as far back as the early 1990s.

We recently wrote that patient advocates maintain that the current drug allergy alert on labels of many over-the-counter medications like ibuprofen don’t adequately warn users about the risk of SJS. While prescription medications associated with SJS often bear a Black Box Warning, the U.S. Food & Drug Administration’s (FDA) most urgent safety warning, ibuprofen and other over-the-counter labels usually only warn consumers of “severe allergic reactions,” and make no mention of SJS. Johnson & Johnson does not include a warning about SJS, and its more serious counterpart, TEN, on its Motrin packaging, but may be mandated to beyond FDA labeling requirements, based on recent legal actions.

A judge in another recent case said, “McNeil has known since the 1980s that ibuprofen is associated with SJS/TEN, yet never asked the FDA to include that fact in the OTC label warning, despite the fact it could have done so. Foreign labels for Motrin have long contained more information about SJS/TEN than United States labels, e.g., a patient information leaflet inside bottles of OTC Motrin sold in Germany warns ‘of the side effects associated with this OTC product of rare but serious skin reactions, such as reddening and blister formation . . . which is bullous EM/SJS,’” quoted BNET, citing a California state appeals court ruling.

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