Were Women Put at Risk of Yasmin Side Effects by Lack of Disclosure?

Seattle, WAWhen women make decisions about whether to use Yasmin birth control and other medications, they assume they have all the pertinent information to help them make that decision. That includes information about the risk of Yasmin side effects and any links between Yasmin and DVT or other serious complications. When drug companies fail to provide that information, patients' lives could be at risk.

According to the US Food and Drug Administration (FDA), one of the risks associated with Yasmin, Yaz, Ocella and certain other birth control medications that contain drospirenone is an increased risk of venous thromboembolism (VTE). Venous thromboembolism includes both deep vein thrombosis??"when a blood clot forms in a vein deep in the leg??"and pulmonary embolism, which is when the blood clot breaks off and travels to the lungs. A pulmonary embolism can be fatal.

Just over a year ago, documents unsealed in a court case showed that David Kessler??"former FDA commissioner??"accused Bayer, maker of Yasmin, of withholding information regarding reports of blood clots in women who used Yasmin. Bloomberg (12/5/11) reports that the unsealed documents alleged Bayer did not include information from an analysis that showed an increased risk of blood clots in women who used Yasmin.

Furthermore, Kessler said Bayer not only provided biased data, skewed in favor of Yasmin, but also promoted Yasmin for uses the FDA had not approved, including to treat premenstrual syndrome. Although it is not illegal for doctors to prescribe medications off-label, meaning for unapproved purposes, it is illegal for drug companies to market their medications off-label.

As of December 2011, Bayer faced more than 10,000 lawsuits linked to its birth control pills, with more lawsuits being filed each month. Lawsuits allege Bayer did not adequately warn patients about the risks associated with the use of Yasmin and similar birth control medications.

As early as July 2003, the FDA was in communication with the companies responsible for Yasmin, warning them about misleading marketing of the birth control. At the time, the FDA was concerned about a television ad for Yasmin, noting "the TV ad not only misleads consumers about the efficacy of Yasmin, the ad also minimizes important context about the health risks of the drug."

In September 2011, the FDA issued a Drug Safety Communication about birth control pills that contain drospirenone, warning that the agency was concerned about the potential increased risk of blood clots. "Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills, compared to users of other hormonal contraceptives." The agency convened an advisory panel to discuss the risks of drospirenone-containing birth control but has not pulled such birth control off the market.