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Zarah contains drospirenone, which may significantly increase a woman’s chance of developing serious, life-threatening side effects, such as including blood clots, pulmonary embolisms, stroke, heart attack, and death. The FDA has recently issued a safety warning concerning the increased risk of birth control pills containing drospirenone.

What is Zarah?

Zarah is a daily oral contraceptive (“the pill”) approved to prevent pregnancy, treat moderate acne, and for premenstrual dysphoric disorder (PMDD). It is not approved to treat PMS or severe acne. It was approved by the FDA in September of 2010, and belongs to the “fourth generation” of birth control pills that contains drospirenone. Other contraceptives in this class of medications include Yaz, Yasmin, Ocella, Beyaz, Gianvi, Loryna, Safyral, and Syeda.

The Zarah regimen consists of 21 active tablets and seven inactive tables that help a woman stay in the habit of taking the pill at the same time every day. Each active pill contains the following active ingredients:

  • 3 mg drospirenone (synthetic progestin)
  • 0.03 mg ethinyl estradiol (synthetic estrogen)

When taken as directed, Zarah is 99% effective at preventing pregnancy. Several mechanisms prevent pregnancy. Zarah inhibits ovulation (when the ovaries release an egg), changes the cervical mucus (making it difficult for sperm to enter the uterus), and changes the lining of the uterus (making it difficult for a fertilized egg to implant and grow).

Is Zarah the same as Yasmin?

Zarah is a generic form of Yasmin. A “generic medicine” is very similar to its brand-name equivalent. Both medications have the same dose, intended use, side effects, route of administration, risks, safety, and strength. Legally, makers of generic drugs do not have to warn patients of new side effects, which protects generic drug manufacturers from being sued under state liability laws. However, this does not mean that Zarah is safer than Yasmin.

Side Effects of Zarah

Blood clots (arterial thromboembolism) are the most dangerous side effect of using Zarah, because they can lead to serious, life-threatening side effects such as:

  • Heart attack (myocardial infarction)
  • Pulmonary embolisms
  • Deep Vein Thrombosis (DVT)
  • Cerebral hemorrhage
  • Death

How does Zarah cause these serious side effects?

Zarah contains drospirenone, which is a synthetic form of the female sex hormone progestin. All types of birth control that contain progestin increase a woman’s chance of developing a blood clot, but drospirenone significantly increases these risks, so much that the FDA has issued multiple safety warnings.

Drospirenone increases the level of potassium in a woman’s blood, sometimes too much. This can cause the blood to coagulate more easily, particularly in the extremities. In a side effect known as Deep Vein Thrombosis (DVT), blood clots form in the large arteries in the extremities, usually the legs. DVT is one of the most serious side effects of using Zarah, because if a blood clot breaks loose and begins to travel through the bloodstream (called an (“embolism“), it may travel to the brain, heart, lungs, or other major internal organs. If the embolism becomes trapped in the artery, it can block the supply of oxygenated blood to these organs. This is called a stroke, and can lead to permanent debilitating injury or death. A Pulmonary embolism is when a blood clot blocks the artery leading to the lungs. If untreated, 30% of people who have a PE will die, usually within the first few hours.

Do you know the symptoms of a blood clot? If you are taking Zarah, you should talk to your doctor so you can recognize the warning signs of a blood clot, because these symptoms may lead to life-threatening injury. Symptoms may include swelling, sharp pain in the extremity, numbness, a “tingling” feeling, slurred speech, or blurred vision. Blood clots may also be symptomless. If you suspect that you may have a blood clot, contact an emergency physician immediately.

Other serious side effects include:

  • Irregular uterine bleeding
  • Cerebral thrombosis
  • Hypertension
  • Gallbladder disease
  • Hepatic adenomas or benign liver tumors

These side effects are significantly increased for women who smoke and are over 35 years of age.

FDA Studies & Safety Warnings

Numerous studies have linked drospirenone to an increased risk of blood clots, prompting the FDA to issue multiple safety warnings after reviewing the findings of these studies.

Recently, the FDA has also issued the results of its own study. After studying nearly 800,000 women taking oral contraceptives, the FDA found that women have at least a 1.5-fold increased risk of developing a blood clot if they are taking drospirenone-containing contraceptive. The risk is greatest for women in their first year of taking the medication.

Other studies have corroborated these findings. In 2009, two independent studies found that a woman may be twice as likely to develop a blood clot while using drospirenone-containing contraceptives. In 2011, two studies published in the British Medical Journal found that a woman may be between 2-3 times more likely to develop a blood clot while taking drospirenone. In November 2011, the conclusions of a massive Israeli study that followed 329,995 women was published. The Israeli study found a 40% increased risk of developing a blood clot while taking a drospirenone-containing contraceptive.

Clearly, the evidence is mounting that medications such as Zarah have serious side effects. If you have been injured by Zarah, please do not hesitate to contact Collen A. Clark. He is passionate about helping people who have been injured by birth control medications.