Lawsuits put focus on Ibuprofen for children

SAN JOSE, Calif. — Nine-year-old Kaitlyn Langstaff of Saratoga, Calif., died 20 months after taking Children's Motrin. Seven-year-old Sabrina Brierton Johnson of Los Angeles went blind two months after taking the same drug. Three-year-old Heather Rose Kiss of New Jersey died a week after taking a few doses of Children's Advil.

All three girls developed a rare, excruciatingly painful disease after an apparent allergic reaction to ibuprofen. And the parents of all three said they never dreamed an over-the-counter pain reliever could kill or disable their children.

The U.S. Food and Drug Administration has not required the makers of ibuprofen to include the life-threatening disease or its symptoms on nonprescription labels for children and adults medicines. But warnings are required on prescription-strength ibuprofen and other prescription drugs that can cause the same rash as the disease.

The FDA and a spokesman for the maker of Children's Advil said no warning is needed because the disease is so rare.

There are an estimated one to six cases of Stevens Johnson Syndrome per million people in the United States each year, some caused by drug reactions.

Stevens Johnson syndrome (SJS) and its various forms can afflict people of all ages. But the Stevens Johnson Syndrome Foundation has seen a jump in reports of cases involving children and ibuprofen in the past year.

About the syndrome There are an estimated one to six cases of Stevens Johnson Syndrome per million people in the United States each year. It can advance to toxic epidermal necrolysis. Symptoms of the syndrome include rash, blisters on the ears, nose and genital area, and sores on the inside of the mouth. More information: Stevens Johnson Syndrome Foundation, www.sjsupport.org

"We're getting about one or two reports of new cases each month," said Jean McCawley, director and founder of the Westminster, Colo.-based foundation. "The only thing that's rare about SJS is that it's not mandatory to report it to the FDA."

After the third lawsuit in two years was filed last week against the makers of Children's Motrin — health-care giant Johnson & Johnson and its subsidiary McNeil Consumer & Specialty Pharmaceuticals — a spokeswoman said McNeil will look into the case.

"As the makers of Children's Motrin products, we are deeply concerned by all matters relating to our products and we are investigating the situation," said Bonnie Jacobs of Fort Washington, Pa.-based McNeil.

Fran Sullivan, spokesman for Wyeth Consumer Health Care, the maker of Children's Advil, said he had no personal knowledge of Heather Rose Kiss' death, but added: "If it turns out this child died after taking Children's Advil, we would look into it as well. We want to get the information so we can investigate it."

In the suit filed last Tuesday, Sabrina Brierton Johnson and her parents allege that Motrin's makers knew the product could cause the rare and sometimes deadly allergic reactions called Stevens Johnson Syndrome and toxic epidermal necrolysis — and that they failed to warn consumers.

The family is seeking monetary damages, but also wants the drug maker to take Children's Motrin off the market until it carries a warning about the syndrome and its symptoms.

They said parents and doctors need to know that they should stop giving children ibuprofen at the first sign of a rash to prevent the disease from advancing to the more serious toxic epidermal necrolysis, which kills about a third of its victims. Symptoms also include blisters on the ears, nose and genital area and sores on the inside of the mouth.

Kaitlyn's parents received a confidential settlement in a similar suit in November and said they can't discuss the case. McNeil also settled in November with the parents of a young Texas girl.

Before the settlement, Kerry Langstaff, Kaitlyn's mother, said the family hoped to educate the medical community and parents about the over-the-counter drug causing this disease.

"We can't tell you how many doctors and nurses have said to us, 'I didn't know,' " Langstaff said.

Not M&Ms

After a 20-month struggle to overcome the disease, which left her unable to see, speak, breathe on her own or eat without a tube in her stomach, Kaitlyn died just before Christmas a year ago.

Dr. Roy Levin, who said he was unaware of the association between Children's Motrin and Stevens Johnson Syndrome until he treated Kaitlyn, said of the drug companies: "They have to warn people who think it's as safe as getting M&Ms."

And Darlene Kiss, Heather Rose's mother, said she believes parents have the right to know that medicines used routinely for children have the potential for such catastrophic consequences.

"Even if it's a verbal warning from the doctor, it would make you think," Kiss said. Heather Rose Kiss died March 17, 2003. Her mother has hired an attorney but has not filed suit.

A number of other drugs can cause Stevens Johnson Syndrome, and some of them carry warnings about the risk of severe skin reactions. Although the FDA has acknowledged that ibuprofen can cause the syndrome, it has not ordered pharmaceutical companies to mention the disease on over-the-counter ibuprofen labels, saying the risk of harm is too low.

Space on drug labels should be devoted to more common adverse reactions, such as gastrointestinal bleeding and kidney problems, it says.

"There is only so much you can put on a label," the FDA said in a statement. "We already know that the longer the labels, the less someone is going to read them."

The FDA said it has received about 150 reports of the syndrome in patients who had used ibuprofen over the years. The agency would not say how common a side effect needs to be to trigger a specific warning on the label.

However, Pfizer announced last month that it will add a "black-box" warning — the strongest a drug can carry — to the label of its prescription painkiller Bextra after 87 people taking the drug developed severe skin reactions, including Stevens Johnson Syndrome and toxic epidermal necrolysis, and four died. Bextra and ibuprofen are part of the same broad class of drugs, known as nonsteroidal anti-inflammatory drugs, or NSAIDs.

Medical problems

These days Sabrina is back at home, but her eyes are so sensitive to light that she must wear a hat pulled down over her face all the time, and she has numerous other medical problems from the disease.

"Johnson & Johnson's failure to warn has cost Sabrina her sight and has cost other innocent children their lives," her mother said. "It's time for the truth to be told, and it's time for Johnson & Johnson to do the responsible thing and put proper warnings and instructions on Children's Motrin."