Regulatory Authorities Ordered the Revision of Labels For Popular Oral Contraceptives

Several popular birth control pills have recently become the subject of increasing scrutiny. According to healthcare officials, those who take oral contraceptives on a regular basis may significantly increase their risk of developing a severe blood clot. Of significant concern, however, is the development of life-threatening complications that may ensue. Subsequently, in order to address this critical issue, officials at the U.S. Food and Drug Administration (FDA) have ordered the labels on drospirenone-containing contraceptives to include the risk of blood clots.

According to the Centers for Disease Control and Prevention (CDC), approximately half of all the pregnancies in the U.S. are unintended. Furthermore, of those women who are sexually active, nearly 99 percent have used a variation of contraception. However, 10.7 million women in the U.S. chose the form of oral contraception, making it the most popular choice.

Recent birth control pills, otherwise known as fourth generation contraceptives, utilize a synthetic hormone known as drospirenone. Drospirenone 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, the use of such birth control pills has recently been associated with serious side effects. Of significant concern, are the elevated blood potassium levels that may coincide with the use of birth control pills. 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

Due to the increased risk of these adverse events, the FDA has ordered all drospirenone containing contraceptives to have their labels changed to reflect said complications. Accordingly, the FDA has recently completed a review of observational studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Based on the data acknowledged in the review, officials at the FDA have concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. To put the risk of developing a blood clot from a birth control pill into perspective: The risk of developing a blood clots is higher when using any birth control pills than not using them. As a result, the FDA has requested a label change.

According to a Drug Safety Communication, the revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins.

The following birth control pills will be receiving the revised label change:

  • Yasmin
  • Ocella
  • Gianvi
  • Yaz
  • Beyaz
  • Safyral

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 suffered from a blood clot after taking birth control, 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-(949) 557-5800.