According to a drug safety communication posted today on the U.S. Food and Drug Administration’s website, the agency announced that it has yet to reach a conclusion regarding the safety of certain drospirenone-containing birth control pills. Data from an agency-funded study involving 800,000 women has now undergone preliminary analysis and suggest a 1.5-fold increase in the risk of blood clots for those women using drospirenone-containing birth-control pills, compared to those taking other forms of hormonal contraceptives. Popular and controversial brands like Yaz and Yasmin, both heavily marketed by manufacturer, Bayer AG, are prime examples of the type of drospirenone-containing pills currently under scrutiny. Other drospirenone-containing products include, Ocella, Safyral, Syeda, Zarah and Beyaz.
While the FDA has not yet reached a conclusion regarding the risk for blood clots in women using drospirenone-containing pills, the agency still remains greatly concerned over the potential increased risk. Conflicting information from a number of published studies regarding the risk associated with drospirenone, has prompted the FDA to convene a panel of outside medical experts on December 8th in order to discuss the data in greater detail.
In the meantime, the FDA has asked that healthcare professionals inform women taking drospirenone-containing products of the potential for developing blood clots.+Frank Eidson