Motrin Lacks Warning on Dangerous Skin Reactions

Motrin, the pain killer known generically as ibuprofen, can cause an allergic reactions – Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) – that make skin shed off. According to BNET, citing a California state appeals court ruling, Johnson & Johnson knew Motrin could lead to this dangerous reaction, and has known about this side effect since the 1980s.

J&J does not include a warning about SJS, and its more serious counterpart, TEN, on its Motrin packaging, but may be mandated to, according to the ruling, said BNET. And, the mandate could be required beyond U.S. Food and Drug Administration (FDA) labeling requirements.

Another problem revealed in the ruling, said BNET, is that drug makers often warn of drug risks overseas, but never advise American patients. For instance, BNET pointed out that consumers in Germany are aware of the Motrin side effect that causes skin to detach, but Americans remain in the dark.

This California case involved 15-year-old Christopher Trejo, who sued J&J. After taking Motrin, Christopher developed TEN, said BNET. The U.S. Motrin packet does not warn of this side effect and, worse, the FDA does not mandate that J&J list SJS and TEN, only mandating that the label warns, in general terms, about severe allergic reactions.

The judge disagreed and 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.

Despite that J&J complied with FDA regulations, the ruling states, “… petitioners failed to provide adequate warnings concerning SJS and TEN (though they have long known about them), … [T]hrough many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market,” quoted BNET.

SJS causes blistering of mucous membranes, typically in the mouth, eyes, and vagina and patchy areas of rash. TEN presents with a similar blistering of mucous membranes. However, in addition to blistering, the entire epidermis peels off in sheets from large areas of the body.