Zarah Lawsuit

Zarah is the generic form of Yasmin, made by Watson Pharmaceuticals, Inc. It is one of many “fourth generation” birth control pills that contains drospirenone (a synthetic version of the female sex hormone progestin). Numerous studies have linked drospirenone to serious, life-threatening side effects – including blood clots, strokes, pulmonary embolisms (PE), and in rare cases, death.

What is Zarah?

Zarah received FDA approval in September 2010. It is the generic version of Yasmin, which means that it contains the same amount of active ingredients as Yasmin. Zarah belongs to a new class of oral contraceptives that contain drospirenone. Other birth control pills that contain drospirenone are Yaz, Yasmin, Ocella, Beyaz, Gianvi, Loryna, Safyral, and Syeda.

The Zarah regimen consists of 21 active tablets, each containing 3 mg of drospirenone and 0.030 mg of ethinyl estradiol. Seven additional tablets are inactive, but help a woman stay in the habit of taking Zarah every day.

When taken correctly, Zarah is more than 99% effective at preventing pregnancy. It works by inhibiting the ovaries from releasing an egg (ovulation), but also changes the cervical mucus (which increases the difficulty of sperm entry into the uterus) and the endometrium (which reduces the likelihood of implantation). Zarah and Yasmin have been incredibly popular and profitable drugs – total U.S. sales were approximately $97 million for the twelve months ending June 30, 2010, according to IMS Health.

Non-FDA Studies of Drospirenone

All birth control pills increase a woman’s risk of blood clots, but with older types of synthetic progestin/estrogen, the risk was small. Five new studies of drospirenone have raised alarm because they have shown a significantly higher risk of developing blood clots compared to older forms of oral birth control. Drospirenone increases the level of potassium in a woman’s bloodstream more than other types of synthetic progestin. High levels of potassium increase the likelihood that blood clots will form.

Several non-FDA studies have found similar results:

• The results of two studies published in 2009 found that women may be twice as likely to develop a blood clot compared to women using other forms of birth control.
• The results of two additional studies published in 2011 in the British Medical Journal, which reported that a woman taking birth control with drospirenone may be up to three times more likely to develop a blood clot.
• A fifth study followed 329,995 women in Israel who were taking birth control with drospirenone, and the incidence of thromboembolic events was compared to women who were taking older contraceptives. The study found the risk of blood clots may be more than 40% higher for the new types of contraceptives.

FDA Study & Safety Announcement

Results of the FDA study were announced in October 2011. After following nearly 800,000 women using fourth generation contraceptives, including Zarah, the FDA found that women have at least a 1.5-fold increased chance of developing a blood clot after using drospirenone-containing birth control, such as Zarah. The risk of developing blood clots is greatest for women in their first year of taking Zarah.

Side Effects of Zarah

Zarah has the same side effects as its brand-name equivalent, Yasmin, and other fourth generation contraceptives. The most serious side effect of using Zarah is a stroke.

Strokes are caused by blood clots traveling through the blood stream and becoming stuck in the arteries that supply oxygenated blood to an organ. Serious injury or death can occur very quickly if a blood clot becomes lodged in the heart, lungs, brain, or other major internal organs.

Drospirenone increases the level of potassium in a woman’s blood stream, which can lead to the formation of blood clots in the large arteries in the extremities, usually the legs. This side effect is called Deep Vein Thrombosis (DVT). If you are taking Zarah, you should consult your doctor so that you can recognize the symptoms of a blood clot. If you experience swelling, pain, numbness, a “tingling” sensation, slurred speech, or blurred vision, you should contact an emergency physician immediately, because these symptoms may be the precursors to a stroke.

Blood clots caused by DVT may occasionally break loose and travel through the bloodstream. This is called an embolism. A life-threatening side effect of using Zarah is a Pulmonary embolism (PE), when an embolism becomes lodged in the artery leading to the lung. The resulting lack of oxygen can cause serious injury to the internal organs. If untreated, 30% of people who have a PE will die, usually within the first few hours of the event.

The risk of other side effects is increased for women who smoke, particularly women who are over 35 years old. These side effects may include cardiovascular events, liver disease, uterine bleeding, and gallbladder disease.