http://www.nytimes.com/2006/02/18/health/18patch.html
WASHINGTON, Feb. 17 (AP) — A new study shows that women using the Ortho Evra birth-control patch have double the risk of developing blood clots compared with those who take the birth-control pill, the Food and Drug Administration said Friday.
But the agency called the results preliminary and said they did not require immediate action other than advising women to discuss the risk with their doctors.
The finding comes from one of two studies comparing the patch and the pill, said Ortho Women's Health and Urology, maker of the once-a-week patch. The company, based in Raritan, N.J., is owned by Johnson & Johnson.
Last year an investigation by The Associated Press, citing federal death and injury reports, found higher rates of blood clots in women using the patch.
The first study found no increased risk of clots. But the interim results from the second study suggested a twofold increase in the risk of venous thromboembolic events, or clots in the legs and lungs, in women using the patch, Ortho said.
At a briefing on Friday, Dr. Daniel Shames, director of the division of reproductive and urological drug products at the F.D.A., said the risk of a nonfatal blood clot was about one per year in 10,000 women not using a contraceptive. For those using a hormonal contraceptive like the patch or pill, the risk rises to 3 to 5 per 10,000, Dr. Shames said.
He noted that in preapproval testing of the patch on about 3,000 women, there were two reports of blood clots, but that one involved a woman who had had surgery.
The continuing studies are also looking at the risk of heart attacks and strokes among users of the two types of contraception. Currently, there is no difference, but the numbers are small, and it will take 18 more months to see if a difference occurs, Dr. Shames said.
The company said the risk of clots remained rare and added that clots were a potential risk of all hormonal contraceptives.
Release of the interim results comes four months after the drug agency warned women that the increased levels of
hormones released by the patch put them at higher risk of blood clots and other serious side effects. Ortho said it shared the results of the latest studies with the agency.
Additions to the patch label in November warned women that they would be exposed to about 60 percent more
estrogen than those who used birth-control pills.
Since the patch went on sale in 2002, more than four million women have used it.
The investigation by The Associated Press found that patch users died and suffered blood clots at a rate three times as high as that for women taking the pill. About a dozen women died in 2004 from blood clots believed to be linked to the patch, The Associated Press reported.
Health officials warn that women who smoke should not use the patch, because
smoking increases the
risk of stroke and heart attack.
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