American Congress of Obstetrics and Gynecologists' Position on Drospirenone, Yasmin

Washington, DCIn the same week that Bayer AG announced in its Q3 results that it had agreed to pay a combined $750 million (so far) to settle almost 3,500 Yasmin and Yaz blood clot claims, the American Congress of Obstetricians and Gynecologists (ACOG) released new recommendations with regard to oral contraceptives, such as Yasmin birth control, that contain drospirenone.

All oral contraceptives carry the potential for blood clot—although the risks are small. It's the introduction of the third-generation birth control pills containing the synthetic hormone drospirenone that has prompted the waving of red flags amongst a growing number of consumers and women's health advocates.

ACOG agrees that Yasmin blood clots are a risk, together with otherdrospirenone-based contraceptives. And yet the Congress is taking a cautioned stance by referencing a "possible minimally increased risk" of blood clots and deep vein thrombosis (Yasmin DVT). While agreeing that various studies have suggested an increased risk, one of the authors of the new basket of recommendations notes that such risks remain, in their view, uncertain. Dr. Kavita Nanda, in comments published in the Orlando Sentinel (10/26/12), said the uncertainty stems from "study weaknesses."

Dr. Nanda did not venture what those weaknesses might have been. However, various studies—some of them published in respected medical journals including the British Medical Journal—have nonetheless targeted Yasmin birth control and Yaz side effects with concern over a higher incidence of blood clots.

What's more, the FDA's own study, entitled "Combined Hormonal Contraceptives and the Risk of Cardiovascular Disease Endpoints," revealed that drospirenone contraceptives such as Yasmin birth control and its close cousin Yaz could increase the risk for blood clots, Yasmin DVT and pulmonary embolism by as much as 74 percent.

The latter study was released just over a year ago, October 27, 2011.

Yasmin birth control and Yaz blew onto the market with much fanfare within the last decade, quickly rising to become the most popular oral contraceptive in America and favored by teens and young women due to claims the dynamic duo could help alleviate bloating, PMS symptoms and even acne. Bayer has consistently defended its product, noting that all birth control pills carry some risk for blood clot.

However, according to the Orlando Sentinel some studies have suggested the risk for blood clots amongst contraceptives containing drospirenone are as high as 10 cases per 10,000 women each year. That compares with three, to nine cases in 10,000 for all women using oral contraceptives and one, to five cases in 10,000 amongst women who are not pregnant and not taking a consecutive at all.

There have been thousands of Yaz lawsuits, and similar litigation involving Yasmin, claiming grievous injury or even death after taking the drospirenone-based pills for a relatively short period of time. And even with its cautionary stance, the statement by ACOG that drospirenone-based contraceptives could hike the risk for blood clots, even minimally, is useful information for any Yasmin litigant and their Yasmin lawyer.
ACOG's statement was published in Obstetrics & Gynecology.

While Bayer is currently focusing on blood clots only at the present time, industry pundits have noted it could cost the company upwards of $1.5 billion in total to resolve all cases of Yaz side effects and adverse reactions associated with Yasmin.