Ortho Evra Patch Blood Clot Risk Requires New Warnings: FDA Panel

A panel of federal drug experts has recommended that the FDA require clearer warnings to alert women that side effects of the Ortho Evra birth control patch may increase the risk of blood clots when compared to using some older oral contraceptives. However, the panel did not recommend that the FDA issue an Ortho Evra recall due to the potential dangers.

The FDA convened the advisory committee last week to review the risk of blood clots 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.

Although the panel voted 19-5 that the benefits of the Ortho Evra outweighed its health risks, they voted 20 to 3, with one abstention, 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 placed on the shoulder, arm, abdomen or on the back near the buttock. While it 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 venous thrombotic events (VTEs) in women.

In May 2008, the prominent consumer group Public Citizen filed a petition with the FDA urging that the regulatory agency recall Ortho Evra birth control due to the risk of serious and potentially fatal injury.

While the FDA panel did conclude that the Ortho Evra patch blood clot risk was higher when compared to older birth control pills like levonorgestrel, they did not recommend that the FDA remove Ortho Evra from the market, as it is the only birth control patch available and may be vital for women who cannot take an oral contraceptive.

The FDA committee’s recommendations would call for the language to be simplified and made clearly understandable by consumers; a goal the current label fails to reach, the panel decided. 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 earlier in the week 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.