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Stevens Johnson Syndrome Latest News

New Treatment for Steven Johnson's Syndrome

July 24, 2005

Stevens-Johnson Syndrome is a strange disease. It's actually a rare allergic problem. In most cases, the skin and even the lining covering the eyes are affected by sort of drying out. Even the tear ducts can become scarred and closed off leading to severely dry eyes, which ultimately can lead to impaired vision, even blindness. Now, here's what's new. Doctors at Washington University School of medicine in St. Louis have performed what they say is the first procedure in the country that transplants a salivary gland from under the jaw to the eye, improving vision as moisture returns to the eye.

To read the entire article, click here.

Lawsuits Prompt Closer Look At Rare Disease Linked To Ibuprofen

January 3, 2005

Nine-year-old Kaitlyn Langstaff of Saratoga died 20 months after taking Children's Motrin. Sabrina Brierton Johnson of Los Angeles went blind two months after the 7-year-old took 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 that an over-the-counter pain reliever sold everywhere from supermarkets to the corner 7-Eleven 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 non-prescription labels, even though warnings are required on prescription-strength ibuprofen and other prescription drugs that can cause the same reactions. The FDA and a spokesman for the maker of Children's Advil told the San Jose Mercury News that no warning is needed because the disease is so rare.

But 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, spokeswoman for the Fort Washington, Penn.-based McNeil.

Fran Sullivan, spokesman for Wyeth Consumer Health Care, the maker of Children's Advil, told the Mercury News he had no personal knowledge of Heather Rose's 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, 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 has about a 30 percent mortality rate. 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 no longer discuss the case. McNeil also settled in November with the parents of a young Texas girl.

Prior to the settlement, Kerry Langstaff, Kaitlyn's mother, said the family hoped to educate the medical community and parents about this 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.

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 Langstaff, said of the drug companies: "They have to warn people who think it's as safe as getting M&Ms."

And Darlene Kiss, Heather'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," said Kiss, who named her baby daughter Heidi Rose in honor of Heather Rose, who died March 17, 2003. Kiss has hired an attorney but has not filed suit.

A number of other drugs can cause Stevens Johnson Syndrome, and some of them - including prescription-strength ibuprofen - carry warnings about the risk of the severe skin reactions. Though the FDA has acknowledged that ibuprofen can cause the syndrome, the government has not ordered pharmaceutical companies to mention the disease that killed Heather Rose and Kaitlyn on over-the-counter ibuprofen labeling, 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, the agency says.

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

There are an estimated one to six cases of Stevens Johnson Syndrome per million people in the United States each year, due to drug reactions as well as other causes. The FDA told the Mercury News 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 is part of the same broad class of drugs known as non-steroidal anti-inflammatory drugs or NSAIDs as ibuprofen.

The FDA has been under fire for months over its handling of safety concerns about other drugs, including Vioxx, a top-selling prescription NSAID used to treat arthritis pain. Vioxx was removed from shelves around the world in September after it was linked to an increased risk for heart attacks.

An FDA advisory committee in February will consider risks of Vioxx, Bextra and other NSAIDs "to determine whether additional regulatory action is needed," the agency said in Dec. 23 statement. It was not known whether the committee would address ibuprofen or Stevens Johnson Syndrome.

Stevens Johnson Syndrome and its various forms can afflict people of all ages. But the Stevens Johnson Syndrome Foundation has seen a jump in the number of cases involving children and ibuprofen reported to it in the past year.

"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."

Lawsuit Claims Motrin Caused Child's Blindness

December 29, 2004

A 7-year-old girl on Tuesday sued the maker of Children's Motrin for failing to label the over-the-counter pain reliever with a warning that it could lead to an allergic reaction that caused her blindness.

The lawsuit filed in Los Angeles Superior Court alleges that Sabrina Brierton Johnson suffered from Stevens-Johnson Syndrome, a potentially fatal rash of the skin and mucous membranes which caused her to go blind.

"As the makers of Children's Motrin products, we are deeply concerned with all matters related to our products and we are investigating the situation," said Bonnie Jacobs, a spokeswoman for McNeil Consumer & Specialty Pharmaceuticals, the Johnson & Johnson subsidiary that makes Motrin.

The company would not comment on the litigation, except to say that the company is aware of the situation with the girl.

Jacobs said the company is still getting a lot of information about the matter and was unable to comment further.

Dr. Stephen Setter, assistant professor of pharmacotherapy at Washington State University, said Stevens-Johnson and Toxic Epidermal Necrolysis, a related ailment, are very rare. There are about two to three cases per million people annually in Europe and the United States, he said.

Ibuprofen, a widely used pain reliever, is the active ingredient in Motrin, Advil and a variety of medicines. The condition occurred with users of the antibiotic Bactrim, pain reliever Bextra and a variety of other drugs as well as ibuprofen.

"Ibuprofen is a very useful drug and works very well in kids, in adults and geriatrics as well," Setter said. "It would cause undue alarm if they had an image of Stevens-Johnson in their heads every time they look at an Advil bottle."

The condition is characterized by a rash, blisters or red splotches on the skin, a persistent fever, swelling eyelids, and flu-like symptoms.

"I would like to warn all the parents out there that we followed all directions for this product. The result is that for 16 months my child has been tortured," Sabrina Brierton Johnson's mother Joan Brierton Johnson said at a press conference.

In addition to her blindness and several eye surgeries, Sabrina Brierton Johnson is now extremely sensitive to sunlight and must be covered up to go outdoors, her mother said.

The lawsuit comes as pain relievers, both prescription and over-the-counter, face more scrutiny over their safety in the wake of Merck & Co. Inc.'s recall of Vioxx in September and recent studies that showed risks with Pfizer Inc.'s Celebrex and over-the-counter drug naproxen.

In addition to damages, the lawsuit calls for Children's Motrin to be removed from the market until it carries a warning label detailing the risk of Stevens-Johnson Syndrome and describing its symptoms.

"This is the equivalent of a medical tsunami -- there was no warning put out whatsoever on this apparently benign, over-the-counter medicine," Sabrina Brierton Johnson's attorney said.

Her attorney said the drug's label included a warning of the allergic risk when it was sold on a prescription basis, but the warning was removed when over-the-counter sales began in 1995.

Jean McCawley, founder of Stevens-Johnson Foundation, whose daughter suffers from the condition, said cases are typically under-reported to the Food and Drug Administration because there is no mandatory reporting system for adverse drug reactions.

Lawsuit Claims Children's Motrin Causes Severe Side-Effects

December 28, 2003

The parents of a 7-year-old girl Tuesday sued the makers of Children's Motrin and several other companies that distribute it, claiming their daughter lost her eyesight and suffered other severe side effects after taking the medication.

The lawsuit, filed on behalf of Sabrina Brierton Johnson of Los Angeles, seeks unspecified compensatory and punitive damages against health care giant Johnson & Johnson, subsidiary McNeil Consumer & Specialty Pharmaceuticals, and several other firms, including retailers Ralphs Grocery and Albertsons Inc.'s Sav-On pharmacies.

Kenneth and Joan Brierton Johnson accuse the defendants of negligence, breach of warranty and of concealing from consumers and doctors potential health risks of taking the flu and pain medication, specifically the risk of developing two disorders Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis which are typically caused by an adverse reaction to a drug or virus.

Sabrina took Children's Motrin drops Sept. 8, 2003, after she came home from school with a fever. The girl had no known drug allergies, according to the suit filed in Los Angeles County Superior Court.

The next morning, she woke up with a high fever and other symptoms, including a pink coloration in her eyes and sores in her mouth. She was hospitalized; a day later she was blind in both eyes.

Doctors later concluded Sabrina had contracted Stevens-Johnson Syndrome from taking Children's Motrin, according to the lawsuit. Since then, she has had multiple eye surgeries.

"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," the girl's mother said in a statement.

Bonnie Jacobs, a spokeswoman for Fort Washington, Pa.-based McNeil, which manufactures Children's Motrin, said McNeil and Johnson & Johnson were aware of a report that a 7-year-old girl allegedly developed Stevens-Johnson Syndrome after taking the medication.

"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," Jacobs said.

She declined to discuss the case further.

Representatives of Sav-On and pharmaceutical distributor McKesson Corp., also a defendant, declined to comment. Messages left with Dublin, Ohio-based Cardinal Health and Kroger Co.'s Ralphs chain were not immediately returned.

If you or your child has suffered Stevens Johnson Syndrome or Toxic Epidermal Necrolysis from taking Children's Motrin, Bextra, Bactrim or other medications, please contact an SJS lawyer at Nadrich & Cohen, LLP immediately. We are representing Stevens Johnson Syndrome victims nationwide.

Call us at 1-800-718-4658 for immediate assistance
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