Yasmin Birth Control Containing Drospirenone Gives Birth to More Lawsuits

Washington, DCThe newest form of birth control, Yasmin/Yaz, has given birth to a mass tort against Bayer Corp., the manufacturer. Several lawsuits filed in federal court claim that a new ingredient-- the progestin component called drospirenone—presents dangerous risk that the company failed to warn about. The lawsuits also claim fraudulent concealment of safety information.

According to Drug Injury Watch, the US has been slow to warn the public about Yasmin birth control. In Europe, 40 complaints of pulmonary embolism and deep vein thrombosis associated with the oral contraceptive were reported soon after Yasmin was approved in 2000.

In Holland, GPs have been advised not to prescribed Yasmin until studies have established whether it is as safe as other contraceptive pills. The Dutch spontaneous reporting system for adverse drug reactions recently received five reports of thromboembolism as a suspected adverse drug reaction to Yasmin. It reported a 17- year-old woman suddenly collapsed and died after taking the Yasmin for six months. Autopsy showed that she had had a massive pulmonary embolism (PE).

But the US has only recently filed product liability lawsuits on behalf of women who have developed PE or deep vein thrombosis (DVT) after using Yasmin or Yaz; they both contain the so-called "fourth generation" progestin drospirenone (DRSP). However, as more women are aware of the dangerous side effects, more Yasmin/Yaz lawsuits will likely be filed.

What is Drospirenone?

Drospirenone, or DRSP, is a diuretic that causes an increase in potassium which can lead to "hyperkalemia" or unsafe levels of potassium that disrupt heart rhythms and slow the flow of blood. Hyperkalemia can lead to blood clotting. Elevated potassium levels are also known to cause potentially life-threatening heart problems and other health issues.

According to one lawsuit, "No other birth control uses a diuretic as an active ingredient". The suit also points out that the number of adverse events reported to the FDA appears disproportionately higher for Yaz and Yasmin than for other birth control pills.

The diuretic causes you to lose water and so you develop sludge or bile that wipes out the gallbladder. Thanks to Bayer's TV ad campaign, some women used Yaz to treat acne and premenstrual syndrome (PMS); another lawsuit claims some women who were not of child-bearing age suffered gallbladder removal or sudden death after taking the pills for acne. (In 2008, the FDA warned Bayer about TV ads and false claims for treating acne and PMS.)

Bayer now warns that if you are taking Yasmin and it is also increasing potassium, you should have your potassium levels checked.

Why does this "fourth generation" oral contraceptive contain DRSP? One reason is that first generation birth control pills were found to cause health risks because of the levels of the estrogen component ethinyl estradiol. The recipe had to be changed.

In the wake of so many adverse reports, Global Insight reports that Bayer Schering has scaled back production of Yasmin and Yaz. The company reports that, although "new formulations of YAZ are still being launched, it is other, newer drugs such as Nexavar that hold the most potential to create strong top-line sales growth for Bayer Schering. The company currently has 20 compounds in late-stage development."

Women can only wonder what the "next generation" of oral contraceptives contain--they certainly don't appear to be getting safer...