It is highly unlikely that a woman has not heard of Yaz, or Yasmin, as a birth control option. We have seen the commercials, read the magazine advertisements, and seen the posters at our OBGYN office. But, are women being rightfully informed as to the apparent risks with these drugs? This was the topic of discussion at a recent FDA advisory panel meeting.
In the recent, very long overdue and highly anticipated hearing, the FDA evaluated the newer oral, patch and ring contraceptives.
The hearing which was held December 8, 2011, was convened because of rising concerns about the safety of widely prescribed birth control pills such as Yaz. Studies indicate women taking the pills face a greater risk of suffering potentially life-threatening blood clots than those taking older versions of oral contraceptives.
In a 19-5 vote, the advisory panel voted that the benefits of the Ortho Evra norelgestromin/ethinyl estradiol transdermal patch outweigh the blood clot risks, but panel members think those risks should be more clearly stated on the label.
An FDA postmarking report in October stated that the patch, the norelgestromin/estradiol vaginal ring, and birth control pills containing drospirenone, were all associated with increased risk for venous thromboembolism (VTE), compared with hormonal contraceptives with relatively low doses of estrogen.
The same panel had also voted 15-11 that the benefits of drospirenone-containing oral contraceptives such as Yaz and Yasmin outweigh the risk of VTE.
Reproductive and drug safety experts advised the FDA to add stronger label warnings of Yaz and Yasmin blood clot risks, but decided not to recommend a Yasmin and Yaz recall.
The panel voted 21-5 to add new blood clot label warnings to drospirenone-based birth control pills, saying that the current warnings are vague, too confusing, and need to be updated with the most recent drug safety information.
One of the most recent reports examined by the committee was from the FDA itself, which found that Yaz and Yasmin side effects increased the risk of blood clots 74% when compared to older birth control pills that use levonorgestrel as a progestin instead of drospirenone. The panel noted that the FDA study did not account for smoking, obesity and some other health factors which could have played a part in its findings.
Yaz and several other pills, including Yasmin, Beyaz and Safyral, contain a synthetic version of the hormone progestin called drospirenone that was thought to have fewer side effects. Bayer, which makes Yaz and Yasmin, has heavily promoted the pills as offering advantages over standard birth control pills, including alleviating acne and preventing premenstrual symptoms such as moodiness, irritability, bloating, fatigue and headaches. In 2009, the FDA found those claims to be exaggerated and asked Bayer to run corrective television advertisements.
The Ortho Evra patch, from Johnson & Johnson’s Janssen, does not contain drospirenone, but it contains higher levels of estrogen than found in many common second-generation birth control pills (which contain lower doses of estrogen than the first-generation pills introduced in the 1960s).
The panel addressed labeling on the patch, voting 20-3, that it should more clearly state the patch’s risks and calling the current labeling confusing.
Janssen has changed its label three times since 2005 to update the risk of the patch, and earlier this year the FDA added a boxed warning saying that one study found the VTE risk was significantly greater with Ortho Evra than with lower-estrogen birth control pills.
The black box warning was meant to draw more attention to the risk of blood clots, according to Scott Monroe, MD, director of the FDA’s Division of Reproductive and Urologic Products.
The FDA does not have to follow the recommendations of its advisory panels, but it usually does.
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