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Birth Control Label Change Indicates Increased Blood Clot Risk

While fourth generation contraceptives have proven to be capable in assisting in the prevention of pregnancy, prolonged use has recently become a subject of great concern. Subsequently, recent studies lend weight to the long-suspected link between drospirenone-containing contraceptives and the development of life-threatening blood clots. In response to these findings, the U.S. Food and Drug Administration (FDA) has decided to add information about the studies to the labels of drospirenone-containing birth control pills.

According to the Centers for Disease Control and Prevention (CDC), approximately half of all pregnancies in the United States are unintended. Yet, several methods exist in which may prevent the occurrence of unintended pregnancies. Since 2000, several methods of birth control have been introduced to the women of America. However, the most popular method of birth control remains the oral contraceptive pill, used by 10.7 million women in the United States.

The most recent form of oral birth control, otherwise known as a fourth generation contraceptive, utilize a synthetic hormone called drospirenone. Drospirenone-containing contraceptives are indicated to assist in the prevention of pregnancy. When taken as directed, they are 91–99 percent effective.

Drospirenone, otherwise known as a progestin, has the inherent ability to alter the conditions in the cervical and uterine lining, therefore preventing the ovulation process in women (which increases the difficulty of sperm entry into the uterus). Furthermore, drospirenone reduces the likelihood of implantation by altering the cervical mucus of the endometrium as well. These combined efforts create an inhospitable environment for subsequent sperm.

Unfortunately, prolonged use of such contraceptives has recently been associated with serious side effects. Of significant concern, however, are elevated blood potassium levels that may coincide with drospirenone treatment. According to a recent FDA Advisory Committee, drospirenone-containing contraceptives may increase potassium levels beyond that of which is considered safe. Furthermore, elevated potassium levels may initiate the clotting cascade responsible for the development of blood clots. The formation of an unnecessary blood clot may prevent organs from receiving their required nutrients, resulting in the following complications:

  • Stroke
  • Heart attack
  • Deep vein thrombosis (DVT)
  • Heart arrhythmia
  • Gallbladder disease
  • Pulmonary embolism
  • Death

According to a recent Drug Safety Communication, the FDA has conducted observational studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Based on their findings, officials at the FDA have concluded that these contraceptives may be associated with a higher risk for blood clots than other progestin-containing pills. Furthermore, these results have forced the FDA to require a label change on drospirenone-containing birth control pills.

The revised drug labels requested by the FDA will include epidemiologic studies that reported a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or similar ingredients. To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them.

Drospirenone-containing birth control pills include the following:

  • Beyaz
  • Gianvi
  • Loryna
  • Ocella
  • Safyral
  • Syeda
  • Yasmin
  • Yaz
  • Zarah

Do I Have a Drospirenone Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in drospirenone lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured by drospirenone, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

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