Girl's case highlights rare but severe reaction to Children's Motrin.

A seven-year-old girl and her parents are suing the makers of Children's Motrin after the girl allegedly suffered a severe skin reaction to the over-the-counter pain reliever. The reaction, called Stevens-Johnson Syndrome (SJS), left her blind in both eyes.

The suit alleges that the manufacturer, Johnson & Johnson, has known for nearly 20 years that Children's Motrin can cause SJS but failed to warn consumers about the danger on the drug's over-the-counter labeling. The plaintiffs seek damages for products liability, negligence, breach of warranty, and deceit by concealment. (Johnson v. Johnson & Johnson, No. TC018540 (Cal., Los Angeles County Super. Ct. filed Dec. 28, 2004).)

In 2003, Sabrina Johnson's parents gave her Children's Motrin to treat a fever. Within hours, she had symptoms of SJS: mouth sores, blood-shot eyes, body rash, and high fever. She became blind two days later.

Though SJS is rare, occurring in as few as one in a million people, its consequences can be deadly, with uncontrollable infections sometimes resulting from skin inflammation. SJS has been linked to a wide variety of drugs, including antibiotics and nonsteroidal anti-inflammatorydrugs (NSAIDs) like Children's Motrin.

Sabrina's lawyer, Geoff Wells of Santa Monica, California, said a warning on the label could have made all the difference.

"When her parents were giving her the Motrin, they looked at the label again to see if there was something about blistering around the eyes and lips, but there was nothing on there," Wells said. "So they kept giving it to her even after she was showing signs of problems, not knowing that [the Motrin] could have caused the problem."

Sabrina's doctor was unaware that Children's Motrin could cause SJS, Wells said.

Ibuprofen, the active ingredient in Children's Motrin, was originally approved as a prescription drug for children in 1989. At the time, the suit alleges, the drug came with a warning of SJS. But when Motrin was approved for over-the-counter use in children in 1995, that warning was dropped from the packaging--even though studies the manufacturer used to gain approval for over-the-counter sales allegedly showed that the drug could cause SJS.

Similar claims of harm from Children's Motrin were made in two lawsuits filed in 2003 and settled in 2004. In one case, the nine-year-old victim died.

Reports of SJS in users of Bextra, a widely prescribed NSAID, recently prompted the drug's manufacturer, Pfizer, to add a black-box warning on the drug's label.

For Geoff Wells, Sabrina's lawsuit is significant because it will raise public awareness of a potentially fatal side effect of a popular and easily obtained drug.

"We're taking on the drug manufacturer about a drug that millions of kids get administered to them, and not only do the parents not know about the risk of SJS, but most of the physicians do not know about it," Wells said.

"That is one of the primary purposes of the family bringing this case: If you go to a physician when you have these problems, the physician will know to get you off that drug immediately and try to initiate treatment to reverse the problems."