Saturday, February 18, 2006
Clot Risk for Birth-Control Patch Is Found to Be Double That of Pill
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.
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. Source: NY Times
Well, 3-5 in 10,000 isn't a lot right? But when you consider how many women are on the patch the numbers quickly add up, and all this for a drug usually used for non-medical purposes. The following is from a law firm that is prosecuting Ortho-Evra the developers of the patch:
Blood clots in the lungs were seen in two women given ORTHO EVRA in clinical trials conducted before the drug was approved and in addition to many similar cases in women after the drug was marketed. The FDA has logged 9,116 reports of adverse reactions to the ORTHO EVRA birth control patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six year period.
With 9.9 million prescriptions the numbers of women with extreme complications leading death are just starting to receive media exposure. In July 2005, a young, healthy married mother of two children experienced shortness of breath and died the next day. Source.
Hmmmm... maybe I'm glad I didn't participate in the Columbia U. medical study to get paid to wear the patch.