Federal Judge Rules Motrin May Have to Warn About Stevens Johnson Syndrome

January 27, 2012, 5:00AM. By Charles Benson

Chicago, ILJohnson & Johnson must face allegations that it did not properly warn consumers that Children's Motrin may lead to the development of Stevens Johnson Syndrome (SJS), a federal judge ruled, according to Courthouse News Service.

The news source reported that SJS can cause permanent disabilities like blindness and massive skin loss, and its deadlier form, known as Toxic Epidermal Necrolysis (TEN), may also be caused by taking ibuprofen. These extremely rare, life-threatening conditions affect mucous membranes such as the mouth, eyes and female genitalia.

According to the news source, McNeil Consumer Healthcare, a Johnson & Johnson company, has listed the possible SJS link on its labels for prescription Motrin since 1983. Mentions of TEN and SJS on Motrin became a requirement by the US Food and Drug Administration (FDA) in 2006.

However, neither disease is mentioned on FDA-approved labels for over-the-counter and children's versions of Motrin. In 2006, the FDA specifically declined a consumer petition to require manufacturers to mention SJS and TEN on these drugs.

According to the news source, in 2010, the parents of two children who had taken the medication and been diagnosed with SJS and TEN sued McNeil and Johnson & Johnson. The complaint alleged that Motrin labels failed to adequately warn consumers about the potential side effects.

US Magistrate Judge Maria Valdez denied McNeil's motion for summary judgment last week, noting that federal law does not pre-empt the labeling claims, according to the news source.

"Plaintiffs have not alleged that the OTC Motrin warning label should use the terms 'SJS' or 'TEN,' " Valdez wrote. "As opposed to terms like SJS and TEN, consumers are familiar with injuries like blindness and scarring; and including such information does not seem as if it would keep consumers from quickly and easily understanding the potential severity of an adverse reaction to ibuprofen."

Stevens Johnson Syndrome affects a relatively small number of people across the country, but each case can be painful. The Sioux Falls Argus Leader reported that Linda Hoek, a resident of South Dakota, contracted SJS and has been in treatment for more than four months, hoping to fix the "angry red marks" all over her skin.