SJS Victim Sabrina Johnson Asks FDA for Warning Labels on Children's Motrin

Business Wire, Feb 17, 2005

WASHINGTON -- Public Citizen and SJS Foundation Voice Their Support and Call for Federal Registry to Track Stevens-Johnson Syndrome Cases

Sabrina Johnson, a 7-year-old victim blinded by Stevens-Johnson Syndrome, was the first member of the public to address a joint meeting held today of its Arthritis Advisory and Drug Safety and Risk Management Advisory Committees. She asked the U.S. Food and Drug Administration (FDA) to require a warning label about SJS on Children's Motrin and any other drugs that can cause the disease. At a press conference also held today, she was joined by Public Citizen President Joan Claybrook, Stevens Johnson Syndrome Foundation founder Jean Farrell McCawley, Browne Greene with the Santa Monica, CA. law firm of Greene, Broillet, Panish & Wheeler, as well has her mother, Joan Brierton Johnson, and 12-year old brother, Travis Johnson.

Miss Johnson, who must wear a hat which covers her entire face to protect her photosensitive eyes, asked the FDA to: "Please do something so that other children don't get hurt by Stevens-Johnson Syndrome like me. People really need to know about it."

Jean Farrell McCawley, who established the SJS Foundation after her 11-month-old daughter Julie was stricken with SJS, said: "Since the popularity of NSAIDS (non-steroidal anti-inflammatory drugs) use in children for rapidly reducing a fever, we have recorded a dramatic rise in reported SJS cases in children. The SJS Foundation strongly advocates that over-the-counter ibuprofen carry a special warning about the disease and a black box warning be placed in the Physicians Desk Reference. We also call for the FDA to establish a formal registry to record incidents of this devastating disease."

Joan Claybrook, president of the consumer advocacy organization Public Citizen, recounted how 600 children contracted Reye's Syndrome during the four years that Public Citizen fought for labels warning of the link between Reye's and aspirin. Reye's Syndrome is a condition characterized by brain swelling, convulsions and coma that often leads to death. "The story of how the Reye's labeling came about is one of unnecessary, excessive bureaucratic delay, industry influence and heavy political pressure that finally succumbed to overwhelming scientific evidence. After the warning labels appeared, Reye's Syndrome virtually disappeared," Claybrook said. "Let's not have a repeat of the Reye's Syndrome battle. Let's not allow this to drag on for years. The FDA should act now on Sabrina Johnson's request before more children lose their sight."

Browne Greene, who represents Miss Johnson in her product liability lawsuit filed in Los Angeles Superior Court on December 28, 2004 against Johnson & Johnson (NYSE:JNJ) and McNeil Consumer & Specialty Pharmaceuticals, stated that: "Sabrina Johnson's lawsuit is the only warning label that the public is going to get until the FDA requires the makers of ibuprofen to put warning labels about Stevens-Johnson Syndrome on its products. We encourage swift action on the part of the FDA and the medical community to protect consumers through appropriate warning labels and education."