Germany Knew about Children's Motrin SJS. We Didn't

Sacramento, CAAs advanced a society as Americans believe they are to be, there appears to be areas in which other countries in the world excel. One of those areas, it seems, is a simple awareness of what are in the drugs we are taking, and the very real risks involved in their consumption. A recent court ruling in the State of California over Childrens Motrin and its relationship to a grievous skin condition suggests that Americans can and should have better information.

When you're 15, it's a time for absorbing the high school culture and enjoying your friends. Your favorite sports and those pesky studies. And okay, maybe you're one who has to contend with that common teen scourge—acne. However, Christopher Trejo never dreamed of a skin issue far worse than mere pimples…

Stevens Johnson Syndrome is a rare, but altogether frightening skin disorder that is typified by the sloughing away of whole patches of skin, much akin to a serious burn. Stevens Johnson Syndrome, or SJS, is an allergic reaction thought to be triggered by medication—even medication as innocuous as Children's Motrin.

According to a NewsInferno report reprinted from BNET, Trejo erupted in Toxic Epidermal Necrolysis (TEN), which is the more serious cousin to SJS. In a California lawsuit against the manufacturer of Motrin, Trejo alleged that the US Motrin package does not reference SJS or TEN. The US label is limited to severe allergic reactions, without going into detail.

However, it appears that Motrin sold overseas carries more advanced and specific warnings with regard to the dual reactive demons. What's more, it was alleged that the manufacturer of Motrin, McNeil Consumer Healthcare (a subsidiary of Johnson & Johnson) knew all about the risk, but never bothered to include Stevens Johnson Syndrome and TEN in the product labeling.

The presiding judge, according to the BNET source, was direct, suggesting that McNeil had known since the 1980s that ibuprofen is associated with SJS/TEN but never approached the US Food and Drug Administration (FDA) for permission to include the reference in its US product labeling.

The judge also made the point that foreign labeling for Children's Motrin had long referenced rare but serious skin reactions such as reddening and blister formation…bullous EM/SJS.

The court noted that the defendant had complied with FDA regulations. However, "… petitioners failed to provide adequate warnings concerning SJS and TEN (though they have long known about them)," stated the court in its ruling. "[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."

Children's Motrin is sold by prescription as well as over the counter, and is one of the most popular medications to treat discomfort in the world.