Ibuprofen Controversy Continues After Cox-2 Hearings
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http://story.news.yahoo.com/news?tmpl=story&cid=97&ncid=97&e=4&u=/hsn/20050224/hl_hsn/ibuprofencontroversycontinuesaftercox2hearings
Thu Feb 24, 2:03 PM ET
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By Amanda Gardner
HealthDay Reporter
THURSDAY, Feb. 24 (HealthDay News) -- Even though a
government advisory panel recommended last week that
strident warnings be placed on cox-2 inhibitors, some
experts are calling for warnings on related drugs,
especially those given to children.
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At particular issue is over-the-counter ibuprofen
which, along with cox-2 inhibitors like Vioxx and
Celebrex, belongs to the larger category of pain
relievers known as nonsteroidal anti-inflammatory
drugs (NSAIDs).
While the cox-2 drugs have been shown to increase the
risk of cardiovascular problems, ibuprofen (and other
drugs) can precipitate Stevens Johnson Syndrome, a
rare but potentially fatal immunological reaction.
Recent lawsuits brought against ibuprofen
manufacturers charge that children have been victims.
In the last two years, three lawsuits have been filed
against Johnson & Johnson and its subsidiary, McNeil
Consumer and Specialty Pharmaceuticals, the maker of
Children's Motrin, which contains ibuprofen.
The company acknowledged it is aware of the claims
made against its products.
"McNeil Consumer and Specialty Pharmaceuticals is
aware of a report of a 7-year-old girl who has been
diagnosed with Stevens Johnson Syndrome allegedly
associated with the use of Children's Motrin," company
spokeswoman Kathy Fallon said in a statement. "Stevens
Johnson Syndrome is a very rare condition. While the
specific causes of the condition in any given instance
are unknown, it has been reported to be associated
with a wide variety of medications and may be caused
by viral medications."
Her statement added, "As the makers of Children's
Motrin products, we are deeply concerned about all
matters related to our products, and we are
investigating the situation."
Meanwhile, advocates are pushing for tougher warnings.
In written testimony submitted to the U.S. Food Drug
Administration (FDA (news - web sites)) a day before
its advisory panel's three-day hearing began, Jean
McCawley referred to Stevens Johnson Syndrome as "the
dirty little secret of the pharmaceutical companies."
McCawley, whose daughter was blinded by the syndrome,
is the founder of the Stevens Johnson Syndrome
Foundation in Denver. She urged the FDA to issue a
black-box warning for over-the-counter ibuprofen,
which includes such products as Children's Motrin.
Most experts said the problem is a rare one, with an
estimated one to six cases of Stevens Johnson Syndrome
occurring per 1 million Americans.
And what causes the syndrome is still up to some
speculation. According to the U.S. government's
Medline Plus Internet site, the exact cause is
unknown. The disorder is believed to involve damage to
the blood vessels of the skin with subsequent damage
to skin tissues. And the government makes no mention
of ibuprofen as a possible cause, although it lists
cox-2 drugs and some HIV (news - web sites)
medications as possible catalysts.
The syndrome is not an allergic reaction, but an
immunologic one triggered by an infection or a
medication.
"It's a reaction in the immune system that causes
tissue damage and destruction, including removal of
the skin," explained Dr. Jonathan Field, director of
the Allergy/Immunology and Asthma Clinic at New York
University School of Medicine/Bellevue Hospital in New
York City. Patients are often treated in burn units
because they lose so much of their surface skin. The
mortality rate is upwards of 50 percent to 60 percent,
Field said.
While ibuprofen can reportedly precipitate the
reaction, so can sulfur drugs, seizure medications,
antibiotics (including penicillin) and others.
"It's not just ibuprofen," said Dr. Gary Kleiner, an
assistant professor of pediatrics at the University of
Miami School of Medicine. "It could happen with any
drug."
But while Kleiner, Field and others maintained the
problem was extremely rare, McCawley argued that the
number of cases attributable to ibuprofen is rising,
possibly due to more widespread use of the drug.
In 2003, the foundation received one report of Stevens
Johnson Syndrome attributed to Children's Motrin and
one to Children's Advil, McCawley said. In 2004, it
received reports of 12 children developing the
syndrome from over-the-counter NSAIDs. In the first
two weeks of January 2005 alone, two children were
reported hospitalized from over-the-counter NSAIDs,
she added.
"I'm getting seven to 10 calls and e-mails a day from
people who have experienced it," she said. "It's not
rare."
Which is why McCawley traveled to Washington last week
to listen to the FDA hearings and argue her own case.
"We thought it [the FDA hearing] was going to be a
very big opportunity," she said. "I was honestly very
disappointed that there wasn't any coverage of
children's products. That breaks my heart."
McCawley and others argue that aspirin carries
warnings about Reyes Syndrome, another rare
occurrence, and that prescription-strength ibuprofen
and other prescription drugs also carry warnings.
And Pfizer recently announced that it would add a
black-box warning to its prescription cox-2 drug
Bextra after 87 people developed severe skin
reactions, including Stevens Johnson Syndrome. Four of
them died.
But the issue of what to put on a label is a tricky
one.
"How much do you label something? Do you say this can
cause allergic reactions, or can cause a
life-threatening allergic reaction?" Field asked. "Do
you include numbers? If someone said I had a
three-out-of-a million chance of winning the lottery,
would I think I was going to win? No."
"Every drug you take can have a reaction," Kleiner
pointed out.
And just because someone had a reaction while on a
drug, that doesn't mean the reaction was due to the
drug, Field added.
Field thinks it may be more important to emphasize
when to stop the drug.
"You have to have a low threshold to call the doctor
or stop a medicine or seek care," he said. "That's
with any illness or medication."
But for McCawley, the issue is one of visibility.
"We will not give up until SJS is a word that everyone
understands," she said. "We're asking for awareness."
More information
Find out more about the subject at the Stevens Johnson
Syndrome Foundation.
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