Ibuprofen Controversy Continues After Cox-2 Hearings

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Ibuprofen Controversy Continues After Cox-2 Hearings

 

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Thu Feb 24, 2:03 PM ET

 

Add to My Health - HealthDay

 

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.