New York Post
Sunday, May 16, 2004
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.