08202017Headline:

Dallas-Fort Worth, Texas

HomeTexasDallas-Fort Worth

Email Shezad Malik MD JD Shezad Malik MD JD on LinkedIn Shezad Malik MD JD on Twitter Shezad Malik MD JD on Facebook Shezad Malik MD JD on Avvo
Shezad Malik MD JD
Shezad Malik MD JD
Attorney • (888) 210-9693

Ortho Evra Patch Blood Clot Risk Requires New Warnings

Comments Off

A panel of federal drug experts has recommended that the FDA require newer warnings for side effects of the Ortho Evra birth control patch. These patches may increase the risk of venous thrombosis embolism (VTE) when compared to using some older oral contraceptives. The panel did not recommend that the FDA issue an Ortho Evra recall due to the potential dangers.

The FDA recently held the advisory committee to review the risk of VTE with the Ortho Evra patch, as well other newer forms of contraceptives, such as Yaz and Yasmin birth control pills and the NuvaRing birth control ring.

The panel voted 19-5 that the benefits of the Ortho Evra outweighed its health risks, and they voted 20 to 3, to recommend that the birth control patch’s blood clot warnings be rewritten.

Ortho Evra is a form of birth control that is delivered through a patch. Ortho Evra patch is promoted as an alternative to daily birth control pills, some studies have shown that the Ortho Evra patch delivers substantially more estrogen and significantly increases the risk of blood clots and VTEs in women.

The FDA committee’s recommendations would call for the language to be simplified and made clearly understandable by consumers. While the committee’s decisions are not binding for the FDA, they generally factor significantly into the agency’s final regulatory action.

A recent FDA study of all of the newer forms of birth control indicated that women who use the Orth Evra patch or the NuvaRing are 55% more likely to suffer a VTE, which can lead to a pulmonary embolism, heart attack or stroke, than women who take levonorgestrel-based birth control pills.

Women who took Yaz, Yasmin or other generic pills that also use the drospirenone progestin, faced a 75% increased risk of VTE and twice the risk of heart attack or stroke.

The committee voted against recommending a recall for Yaz and Yasmin, but also found that the label warnings should be made more clear on those products as well.