Severe Reaction To Ibuprofen Spurs Call For Warning

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Severe reaction to ibuprofen spurs call for warning labels
By Marsha Austin
Denver Post Staff Writer

Jean McCawley rushed to the pediatrician with her 10-month-old daughter, who had swollen eyes, a blistered mouth and a raging fever. The doctor diagnosed Julie with chickenpox and told McCawley to give her Children's Motrin, which had just become available over the counter, McCawley recalls.

Julie's face erupted with blisters within 20 minutes of taking the first pill. Hours later at the hospital, doctors diagnosed Julie with Stevens Johnson Syndrome, a severe allergic reaction to drugs.

"She had blisters from dime-size to half-dollar. Her face was unrecognizable," McCawley remembers.

Physicians blamed an anti-seizure medicine Julie had been given to control epilepsy. But McCawley is convinced ibuprofen in the Motrin and in intravenous fluids given to Julie at the hospital fueled the reaction that burned through her body, leaving her blind.

Stevens Johnson Syndrome is one of the most debilitating drug reactions and afflicts people of all ages. Almost any medication can trigger the syndrome, which causes the body to turn against itself, burning internal and external organs and tissue.

For the past 10 years, the Westminster mother has been fighting to force pharmaceutical companies to put warning labels on children's ibuprofen products listing Stevens Johnson Syndrome as a possible side effect.

Last week McCawley, founder of the Stevens Johnson Syndrome Foundation, took her case to Washington, D.C., where she testified before a new Food and Drug Administration panel on drug safety.

No public health agency officially tracks SJS cases, and McCawley and other parents of SJS children want that changed, too. She said her foundation counts about 350 new cases a year.

Pharmaceutical companies and some physicians argue that, while debilitating, SJS is so rare that it does not need to appear on over- the-counter ibuprofen products.

"If you do it for ibuprofen, you're going to have to do it for every drug," said Dr. Larry Wolk, a pediatrician and founder of Denver's Rocky Mountain Youth clinics.

"Unfortunately, at any given time, with any given drug," a patient can have an allergic reaction, Wolk said. "The good news is, they are rare, and the benefits (of the drug) far, far, far outweigh the risks."

In 15 years of practice, Wolk said he's treated two cases of SJS.

But parents like Kris Claybaugh of Arvada want to know why the FDA puts SJS warnings on prescription ibuprofen but not the product sold on pharmacy and grocery shelves.

"My daughter had everything going for her, and she had it all taken away from her," Claybaugh said.

When Mollie Claybaugh was 12 years old, Kris gave her one children's ibuprofen tablet to quell a fever. Eight hours later, "she had blisters all around her hairline, her ears were huge, her lips were huge and purple, and she had discharge coming from her eyes," Claybaugh recalls.
Mollie was later diagnosed with SJS.

Now 24, she is blind, requires oxygen and a feeding tube, and lives at home with Kris.