Yasmin and Yaz Tagged by Institute for Safe Medication Practices

Washington, DCQuarterWatch, an offshoot of the Institute for Safe Medication Practices (ISMP), placed Yasmin birth control and its close cousin Yaz at the Number 2 position in the drug watchdog's Top 5 drugs most frequently cited in litigation last year. The third-generation oral contraceptive manufactured by Bayer is heavily favored by women 35 years of age and younger.

One of those women identified by The Blade (6/11/12) is Rhonesha Maston, who was drawn to Yaz as a junior in high school attempting to overcome the pain associated with menstrual cramps. Her doctor suggested Yaz, and she stayed on it four years before stopping when her health insurance ran out.

While Maston did not experience any serious Yaz side effects, others have not been so lucky. The Toledo-based newspaper notes there are currently in excess of 11,000 lawsuits pending against Bayer alleging various injuries—including Yasmin blood clots and similar symptoms involving Yaz—and even some deaths allegedly caused by Yasmin or Yaz.

While it is true, says The Blade, that anywhere from two to four women out of 10,000 will experience a blood clot from taking an oral contraceptive, some studies suggest the risk is two to three times higher with Yasmin and Yaz birth control pills.

QuarterWatch (5/31/12) reported on the ISMP study that tabulated lawsuit-related adverse event reports for 2011 and churned them into a Top 5 list. At #2, Yasmin and Yaz were tagged with 8,354 lawsuit-related adverse event reports for the year ending 2011. Bayer's annual report revealed that some 70 lawsuits have already been settled, and the manufacturer is in the throes of settling many more.

Yasmin and Yaz were originally introduced to much fanfare and quickly took a stranglehold on the contraceptive market amongst younger women. Clever marketing was part of the allure, thanks in part to the reality that women will subscribe to a certain oral contraceptive for reasons other than contraception.

In the case of Maston, now 20 and attending to her studies at the University of Toledo, she was prescribed Yaz birth control pills to help with severe menstrual cramps. Other women have adopted Yaz at the behest of early marketing campaigns and claims that Yaz and Yasmin was effective in combating acne and bloating—claims that regulators took issue with early on, chastising the manufacturer.

The Yasmin pill and its close cousin Yaz, nonetheless, were quickly propelled to pharmaceutical greatness, with worldwide sales a robust $1.8 billion in 2008.

However, the enthusiasm for the contraceptive duo has waned in the face of increased concern over Yasmin DVT (deep vein thrombosis, or blood clot) and Yaz side effects. Some studies have shown a higher risk (albeit small) for blood clots and Yasmin gallbladder problems when compared to older contraceptives. Doctors are in two camps, believing that Yasmin / Yaz is not worth the risk, or no worse than other oral contraceptives.

Bayer subscribes to the latter view, stating that Yaz and Yasmin carry no greater risk for blood clot than older contraceptives. To that end, the Blade referenced the events surrounding former Miss America (1963) Jackie Mayer, who had just switched brands and was on a new oral contraceptive for one month and five days when she suffered a near-fatal stroke in 1970.

That was long before Yaz and Yasmin appeared. Thus, the risk for stroke is nothing new and certainly predates Yaz and Yasmin. But what is hotly debated and litigated, is the potential for Yaz blood clots and other side effects. With more than 11,000 lawsuits pending, the debate over a popular product remains acutely active, as are Yasmin lawsuits.

The US Food and Drug Administration (FDA) mandated increased warnings in April concerning Yaz blood clots and Yasmin side effects. The products remain on the market. Consumers having serious issues with Yasmin and Yaz—and the need for increased warnings that were not so prevalent prior to this year, have fostered many a visit to a Yasmin lawyer for guidance.