[That there is a jump in reports of pediatric SJS suggests a parallel to autism and to models of autism causation. At least preliminarily, we might entertain the notion that the background pollutants which have neurologic and immune effects that overwhelm detox and increase susceptibility may be contibuting to susceptibility to pediatric SJS as well as to autism-spectrum disorders. Also, SJS-underreporting may shape official estimates of SJS rates of occurrence: "The only thing that's rare about SJS is that it's not mandatory to report it to the FDA." Also, 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." Today's news also describes findings about ibuprofen's and other NSAIDS' adverse effects upon the small intestine.-Teresa}

Lawsuits put focus on Ibuprofen for children (brand names: Apsifen Brufen Cuprofen Fenbid Inoven Motrin Nurofen  Proflex)

jan 2005
By Linda Goldston
Knight Ridder Newspapers
http://seattletimes.nwsource.com/html/health/2002139686_ibuprofen04.html

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

"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."

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
<http://www.sjsupport.org>

*

Painkillers damage intestine, U.S. expert says
03 Jan 2005 23:25:54 GMT
By Maggie Fox, Health and Science Correspondent WASHINGTON, Jan 3
Reuters
http://www.alertnet.org/thenews/newsdesk/N03371190.htm

More than 70 percent of patients who took painkillers such as ibuprofen
for more than three months suffered damage to their small intestines,
U.S. researchers reported on Monday.