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Oct 10, 2004 | New York Post

A popular and profitable contraceptive patch promoted by sexy TV ads caused 11 times as many fatal or life-threatening blood clots as a leading birth-control pill, a new lawsuit charges.

The Ortho Evra patch is "defective" and more dangerous than the manufacturer admits, alleges a suit by a Texas mother of two who suffered a massive stroke and is now paralyzed after 12 days on the patch.

The suit, filed last Thursday in Austin, Texas, claims that U.S. Food and Drug Administration records show that at least 46 women wearing the birth-control device suffered clot-related injuries or death in a one-year period.

In the same 12 months, May 1, 2002, through April 30, 2003, half as many women taking a leading birth-control pill by the same manufacturer, Ortho-McNeil Pharmaceutical, suffered similar clots, the suit says, citing FDA records obtained under the Freedom of Information law.

More than six times as many women used the pill as the patch so, comparatively, 11 times more fatal or life-threatening clots were suffered by patch wearers, compared to women using the pill, the suit says.

"They're marketing the drug like crazy and sales are going up every day," sad attorney Ray Chester, who filed the suit. "Nobody has published the number of blood clots, and that's what we're trying to do."

The suit blames the patch for causing Philomena Ugochukwu, 37, a beauty-shop operator with two kids, now 11 months and 5 years old, to suffer a blood clot that resulted in a massive stroke and brain damage last March.

"It's a nightmare seeing my wife in this condition," said Philomena's husband, Ike, 51, a chemist.

He said Ortho-McNeil should take the patch off the market until further research was conducted.

Ortho-McNeil said Friday the company had not yet received the suit, and could not comment on it.

But spokesman Doug Arbesfeld maintained that the "adverse event reports for Ortho Evra are consistent with the health risks of other hormonal contraceptives."

A New York fashion student, Zakiya Kennedy, 18, was the first fatality publicly linked to Ortho Evra after she collapsed in a Manhattan subway station in April. The Medical Examiner found she suffered a blood clot to the lung.

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