FDA Issues Warning On Birth Control Patch Risks

By Dee Chisamera
08:24, January 19th 2008
109 votes
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FDA Issues Warning On Birth Control Patch Risks

The Food and Drug Administration issued a warning on Friday that the use of birth control skin patches increases the risk of blood clots compared to birth control pills. A new study has shown that the risk is almost as twice as big, and it followed Canada’s reports according to which 16 women using the patch developed blood clots since 2004.

There have been previous discussions on higher blood clot risk in patch compared to the birth control pills in 2006, and a warning has been issued on the Ortho Evra Contraceptive Transdermal Patch label, along with another study that reported the same risk as in using the pills. Unfortunately, earlier concerns proved to be accurate, and the FDA recommended changes to the labeling of the patch, in order to raise awareness on the possible risks of using this particular contraceptive method, both for doctors who recommend it and for women who use it.

Dr. Janet Woodcock, the FDA deputy commissioner for scientific and medical programs, said in a statement: “For women that choose to use contraceptives, it is important that they thoroughly discuss with their health-care providers the risks and benefits involved.” The latest study found that blood clots for women aged 15 to 44 were twice as likely to be found in women using the patch compared to women using the pills.

Referring to the contradictory study, the statement also said: “Even though the results of the three studies are conflicting, the results from two of the studies support FDA’s concerns regarding the potential for use of Ortho Evra to increase the risk of blood clots in some women,” but also added that Ortho Evra is a safe method of contraception when used accordingly to the label, which means women with blood clot risk should first consult with their doctor before choosing to use the patch.

However, the study also revealed that while using a hormonal contraceptive method, whatever that may be, the chances to develop blood clots are low, only 3-5 cases out of 10,000 women, and the only real issue here is to first discuss with the doctor before choosing one method or the other, in order to avoid unnecessary complications later on.

 



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