Has Children's Motrin caused SJS, leading to Death and Blindness? If so,why isn't it Withdrawn?

Los Angeles, CAHow many children will it take to suffer and even die from Stevens-Johnson Syndrome (SJS) after taking Children's Motrin before the FDA slaps a black box warning on the drug or even better, withdraws it from the market?

Seven-year-old Sabrina Brierton Johnson went blind soon after taking Children's Motrin. In December 2004 her parents filed a lawsuit against the drug manufacturer Johnson & Johnson (J&J). Sabrina took Motrin for a fever when she came home from school. The next morning she woke with a high fever and was taken to the hospital. By the next day she was blind in both eyes.

In July 2008 J&J won the lawsuit. After a six-week trial the jury voted 9-3 against liability. Jurors decided that J&J had put a drug on the market known to cause sickness and illness, without warning customers, but also found that it had not been proved that Children's Motrin caused Sabrina Johnson to go blind. The lawsuit had alleged that the company failed to label the over-the-counter pain reliever with a warning that it could lead to SJS, a rare but potentially fatal allergic reaction that usually starts with a severe rash of the skin and mucous membranes.

The giant drug company maintained that its product was safe and that packaging materials adequately warned that a doctor should be consulted if any change of medical condition occurred after a young person was given Children's Motrin. Did Sabrina's parents have time to consult a doctor? Like any parent noticing a rash developing, Sabrina's parents gave her another dose of Motrin. If the drug had warnings that SJS or any life-threatening illness could develop from a rash, of course they wouldn't have given her any more Motrin.

The company was forced to change its label slightly in 2005 when a group of doctors noticed a pattern of disease linked to ibuprofen and successfully prodded the FDA to order it, but in Sabrina's lawsuit, Johnson & Johnson's lawyer said that SJS can be caused by dozens of drugs, and there is no proof that Johnson & Johnson's ibuprofen caused the girl's conditions.

"In the name of children everywhere, our family wants Children's Motrin taken off the market until it carries a warning label about the risk of Stevens-Johnson Syndrome and describes its symptoms," said Sabrina's mother.

Two-year-old Maliyah from North Carolina was diagnosed with SJS; doctors believe it was caused by an allergic reaction to Children's Motrin. The toddler spent weeks in hospital and made an incredible recovery from a terrifying illness that could have killed her.

Nine-year-old Kaitlyn Langstaff of Saratoga California died, apparently as a result of taking Children's Motrin. She died after a 20 months illness which left her unable to see, speak, breathe on her own or eat without a feeding tube. Her parents' court case was settled in November of 2004 for an undisclosed amount. Her parents cannot discuss the case.

Mackenzie of Spokane, Washington was only 18 months old when she developed SJS. Mackenzie recovered, but SJS has affected her permanently.

Even after these horrific events, including two deaths, two blindnesses, and many brushes with death after developing SJS allegedly from taking Children's Motrin, the FDA still believes that the incidence of SJS/TEN is so rare that alarming warnings may not be warranted.

Even though Sabrina's family lost their case, lawsuits are still being filed against the maker of Children's Motrin. Lawsuits have accused the manufacturer and distributors of negligence, breach of warranty, and of concealing from consumers and doctors potential health risks of the drug.

Some health professionals have advised parents to consider the risks of using Children's Motrin and to seek alternatives to conventional painkillers and fever medications.