Do You Know Birth Control Patch's Risks?

Sept. 23, 2004 -- Zakiya Kennedy had big dreams of becoming a model or designer.

But in April, those hopes vanished when the 18-year-old college student collapsed while waiting for the subway in New York City. She died on the way to the hospital.

"She was complaining about her head was hurting — she felt pain in her leg and she had — she felt dizzy," her father, Kevin, told ABC News' Chris Cuomo.

An autopsy revealed the cause of death was a blood clot called a pulmonary embolism, a rare and deadly complication of the birth control patch the young woman was using, called Ortho Evra.

If you have questions or concerns about the patch, visit, an interactive Web site, or call 1-877-377-3872, a toll-free number, to reach live, professional health-care specialists.

The patch, which has been used by 4,000,000 women, is like the birth control pill — a combination of estrogen and progesterone. Both share similar effectiveness and health risks. Though the risks are extremely small, some women will die.

"Based on our best estimates — less than two per 100,000 women less than the age of 35" will die from complications of the patch, said Dr. Shaun Biggers of New York Presbyterian Hospital in New York.

The risk of death from pregnancy-related conditions is 15 times greater than the risk of death from the patch, Biggers said.

But the patch is heavily advertised on television with beautiful models touting how easy it is to use. And Biggers said she is concerned that not enough people know about the patch's dangers.

"On some level, it may be a failure of the medical profession in terms of really informing patients," she said.

Pain, Swelling, Shortness of Breath

It's not clear if Zakiya Kennedy knew about that risk.But 17 deaths and 62 life-threatening complications like blood clots might be related to patch use, according to adverse event reports received by the Food and Drug Administration.

The FDA has not concluded its investigation. It says some of those reported deaths may not be linked to the patch and some may be duplications.

Dr. Andrew Friedman, who heads the women's health research unit at Ortho-McNeil, the patch's manufacturer, says knowing the warning signs is important. They include leg pain, swelling, and shortness of breath. "It could be a sign of a potentially dangerous clot," he said.

Kennedy did have some of those symptoms. "She was complaining about pains in her leg or in her shoulder," her father said. "She thought it was from her exercising."

Her family's lawyer, Michael Gunzburg, is calling on both doctors and the company to put out better warnings — no matter how few women may be at risk.

"I think they should disclose it and let the consumer make the decision — if it's one person — two people — if it's 10 people — if it's you, you'd want to know," Gunzburg said.

Pay More Attention

Friedman says Ortho-McNeil does warn consumers in several different ways, including on a product insert.

"On TV, almost half of the time of the advertisement is devoted to talking about the potential risks and potential warning signs that women should be aware of," he said.

There's no mention of death. But Friedman said, "It's possible to always improve any process. So it's possible to, to make the warnings even more understandable to patients and physician."

Roberta Alloway, Kennedy's grandmother, thinks that should happen. "They need to really let people know that my granddaughter and other people have died from this patch," she told Cuomo.

"The pictures they show of the models that are promoting this are big, and the warnings are small," she said. "It's not big enough."

"I can't bring her back," she said. "But I want something to bring attention to these young women."

If you have questions or concerns about the patch, visit, an interactive Web site, or call 1-877-377-3872, a toll-free number, to reach live, professional health-care specialists.

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