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Close Watch on "The Patch" for Now
Ortho Evra, a.k.a. the "birth control patch," has become a popular birth control method that is used by about four million women in the United States. Recent reports in the news media have suggested that there may be higher rates of serious complications in patch users than in women using low-dose birth control pills.
Preliminary data from studies that were supported by Orth Evra's manufacturer produced conflicting results. Both studies failed to show an increased risk in heart attack, stroke, and death, but one of the studies did show an twice the risk of non-fatal "thromboembolic events," presumably deep venous thrombosis and/or pulmonary embolus.
The FDA is closely monitoring the studies, but is currently only recommending that patients be made aware that there are conflicting results in the preliminary studies that compare the rates of side effects in patch users vs. pill users.
I think it's important for patients to realize that although the components and methods of action of the patch and the pill are very similar, the pharmacokinetics of transdermal vs. oral administration are different, and there could be differences in safety profiles. The good news is that although there is risk with any hormonal contraception, the risks are extraordinarily low in young, healthy, non-smokers. And twice a very small risk is still very small. Clearly, further study is warranted, but for now, a well-educated consumer could logically decide that the benefits of using the patch outweigh the unknown, but apparently small risks associated with its use.
RW, MD
Related Topics: Birth Control: Which Choice is Right for You, Condom Quiz
Technorati Tags: orthoevra, thepatch, birthcontrol, hormonalbirthcontrol, fda
Preliminary data from studies that were supported by Orth Evra's manufacturer produced conflicting results. Both studies failed to show an increased risk in heart attack, stroke, and death, but one of the studies did show an twice the risk of non-fatal "thromboembolic events," presumably deep venous thrombosis and/or pulmonary embolus.
The FDA is closely monitoring the studies, but is currently only recommending that patients be made aware that there are conflicting results in the preliminary studies that compare the rates of side effects in patch users vs. pill users.
I think it's important for patients to realize that although the components and methods of action of the patch and the pill are very similar, the pharmacokinetics of transdermal vs. oral administration are different, and there could be differences in safety profiles. The good news is that although there is risk with any hormonal contraception, the risks are extraordinarily low in young, healthy, non-smokers. And twice a very small risk is still very small. Clearly, further study is warranted, but for now, a well-educated consumer could logically decide that the benefits of using the patch outweigh the unknown, but apparently small risks associated with its use.
RW, MD
Related Topics: Birth Control: Which Choice is Right for You, Condom Quiz
Technorati Tags: orthoevra, thepatch, birthcontrol, hormonalbirthcontrol, fda
