PRACTICE
AREAS:: ORTHO EVRA CONTRACEPTIVE
PATCH:: Attorney
New York Post
Sunday, May 16, 2004
'PATCH' SHOCK GROWS
KIN ID NEW 'VICTIMS'
By Susan Edelman and Marsh Kranes
The manufacture of the contraceptive patch that killed
18-year-old Manhattan woman failed to fully warn doctors
and women about the dangers of the device, families
of two other possible victims charge.
Since an autopsy linked the death last month of fashion
student Zayika Kennedy, 18, to the Ortho Evra patch,
two families have told The Post about similar tragedies.
"They (the patched) are killing young women," said
Jermaine Webber, whose wife, Sasha, 25, died of a heart
attack after six weeks on the patch.
In another case, a 22 year old college stated from
Brooklyn suffered a blood clot, but was saved from
death by emergency-room doctors.
In both cases, the families say the risks the young
women faced when they chose the patch over other birth-control
methods were not made clear.
The women, both non-smokers and nondrinkers, felt safe
using the patches, which were placed on the skin and
deliver pregnancy-inhibiting hormones into the bloodstream.
The new cases come as documents obtained by The Post
show that doctors reporting to the Food and Drug Administration
raised serious concerns that the patches could be more
dangerous than oral contraceptives.
The doctors recommended that information about two
women who developed nonfatal blood clots in clinical
trials be made known to doctors and consumers.
The manufacturer, Ortho-McNeil Pharmaceutical, mentions
those results only in a fine-print, technical language
leaflet.
"If the data show the risk of blood clot is higher
than oral contraceptives, that would be a cause of
great concern," said Dr. John Quagliarello, a professor
of obstetrics and gynecology at NYU Medical Center.
Kennedy's death - the result of a blood clot - is the
first fatality known to be linked to the Evra patch
since its approval by the FDA in November 2001.
Ortho-McNeil, a subsidiary of Johnson & Johnson, on
Friday asked The Post for the names of the two new
women so it could look into their cases.
"We're very concerned whenever there are reports of
adverse events," said spokesman Doug Arbesfeld. "Blood
clots are a well-known but rare side effect of hormonal
contraceptives, both oral and the patch."
Weeks before Kennedy collapsed in the subway, Sasha
Webber fell in the street near her Baychester home.
She died an hour later at Our Lady of Mercy Medical
Center.
Webber, the mother of a 5-year-old girl and a 2-year-old
boy, was in her second month on the patch, records
show.
"I was shocked because she didn't smoke or drink, and
she had no illnesses," said her husband, who is considering
suing Ortho-McNeil and Jacobi Medical Center in the
Bronx, a City-run hospital where an unidentified doctor
prescribed the patch.
The City medical examiner found Webber died of a arteriosclerosis,
a heart disease caused by narrowing of the arteries.
It's "highly likely" the patch contributed to her heart
attack, NYU Medical Center's dr. Quagliarello said.
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