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Severe Skin Disease Gets Fresh Attention Amid Cox-2 Worries
Severe Skin Disease Gets Fresh Attention Amid Cox-2 Worries -- Posted by MrPepper11 on 02-08-05 08:13
Wall Street Journal
February 8, 2005
Severe Skin Disease Gets Fresh Attention Amid Worries Over Painkiller
Side Effects
By HEATHER WON TESORIERO
When a Food and Drug Administration panel meets next week to discuss
so-called Cox-2 inhibitors, the focus will be on heart risks associated
with the painkillers. But other serious, little-known side effects can
result from these and other drugs, including a devastating and
potentially deadly skin disease.
Jane Webb, age 64, took Vioxx for years to help quell arthritis pain in
her hands. In July, her doctor switched her to Bextra, another Cox-2
painkiller, to see if it would give her greater relief. A week into
taking the new drug, the retired physics professor from Newport News,
Va., noticed red blotches on her arms. She hadn't been told of any
possible skin reactions, but was worried enough to see her
dermatologist. The doctor diagnosed Stevens Johnson Syndrome, a rare
illness most commonly triggered by medications. By the next day, the
entire surface of her body was covered with blotches, welts and
pimple-like bumps. "They were on my face, in my hair, in my ear," Mrs.
Webb says.
In the long list of drug side effects to worry about, skin reactions
may rank low compared with deadlier problems like heart attack and
stroke. But even rare conditions are very real and can be serious. In
severe cases, SJS, which attacks the skin and mucous membranes, can
result in blindness or death.
Efforts are under way to raise awareness of SJS. In December, Pfizer
Inc., which makes Bextra, strengthened the label's warning on skin
reactions including SJS to a so-called black-box warning. And the
Stevens Johnson Syndrome Foundation is working to create a national
system to track incidence of the disease. But even amid heightened
concern about side effects following the withdrawal last year of Vioxx,
SJS remains relatively unknown to the public. Physicians themselves are
sometimes unfamiliar with the condition, which can lead to an initial
misdiagnosis.
In theory, SJS can result from any drugs. But drugs containing sulfa,
such as the antibiotic Bactrim; nonsteroidal anti-inflammatory
medications such as Cox-2 inhibitors and ibuprofen; anticonvulsives
such as Dilantin; and antigout drugs including Allopurinol, have been
the most frequently implicated in SJS. In children, the disease has
also been associated with a bacterial infection.
According to the National Organization for Rare Disorders, SJS
incidence is estimated at two to seven cases per million people in the
U=2ES. per year, or roughly 600 to 2,000 cases annually. No one tracks
cases nationally, but major medical centers probably each treat six to
12 cases a year, some doctors say.
Classic SJS symptoms include lesions on mucous membranes and itchy,
painful sores and blotches elsewhere on the skin, which typically set
in within a week of taking a drug. Doctors say that early detection and
intervention can lessen symptoms and improve the prognosis.
Patients are always advised to immediately stop taking any new drug
that may have caused the reaction. Antibiotic treatments to inflamed
areas, including the eyes, can help prevent scarring. And oral or
intravenous steroids may be given to reduce inflammation and relieve
pain. "I am a strong advocate of high-dose, short-term steroids," says
C=2E Stephen Foster, professor of ophthalmology at Harvard Medical
School. "It cuts off the legs of the immunological response."
Intravenous immunoglobulin, which boosts the immune system with
concentrated antibodies from donor blood, is also used, at a cost of
$3,000 to $9,000 per dose.
But getting treatment depends on getting diagnosed. Valerie Chereskin,
50, of Encinitas, Calif., developed SJS after taking a sulfa drug in
1990. She saw three doctors before the condition was identified. And
now, Ms. Chereskin, who owns her own communications firm, says she has
been left with permanent eye damage. She says she was never warned that
SJS was a possibility when taking a sulfa drug. "I do think people
should have all the information," Ms. Chereskin says.
There have been cases where patients blamed common over-the-counter
medications for SJS. The parents of a 3-year-old girl in Aberdeen,
N=2EJ., who died of SJS are suing Wyeth, maker of Children's Advil,
claiming the company should have warned patients that SJS is a risk. A
Wyeth spokesman declined to comment on the lawsuit, but noted that the
FDA reviewed Children's Advil and "determined that its labeling does
not require warnings" for SJS.
Sabrina Johnson, 7, from Topanga, Calif., was left blind from corneal
damage from SJS. Her family is suing McNeil Consumer & Specialty
Pharmaceuticals, a Johnson & Johnson unit that makes Children's Motrin.
A McNeil spokeswoman said the company is aware of the case, but that
SJS can be caused by a variety of medications or conditions. She noted
the product label does say ibuprofen "may cause a severe allergic
reaction."
Ken Johnson, Sabrina's father and an aerospace engineer, says, that
though the condition may be uncommon, "when it happens to you, the
concept of rare completely goes away."
WHAT TO LOOK FOR
Some symptoms of Stevens Johnson Syndrome, which typically appear
within a week of taking a new drug:
=B7 Rash, blisters, or red splotches on skin
=B7 Blisters in mucous membranes
=B7 Swelling of eyelids, red eyes
=B7 Persistent fever; flu-like symptoms
=20
=B7 Conjunctivitis
=20
Source: Stevens Johnson Syndrome Foundation
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