Popular Birth Control Pills Given Revised Warning Labels

Birth control pills that contain drospirenone, otherwise known as fourth generation oral contraceptives, have recently become the subject of increasing distain within the healthcare community. Reports indicate that the use of such contraceptives may coincide with catastrophic complications. Of significant concern, however, is their recent association with the development of severe, life-threatening blood clots. Due to the serious nature of these clots, Bayer Healthcare Pharmaceuticals Inc., in association with the U.S. Food and Drug Administration (FDA), announced that they have revised the professional labels on each of their fourth generation oral contraceptives to include the risk of unnecessary blood clotting.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Furthermore, Bayer HealthCare is one of the world’s leading, innovative companies in the healthcare and medical products industry. As a testament to their success, Bayer has released an entire arsenal of drospirenone-containing combination oral contraceptives (COCs) in the United States. Among those that contain drospirenone, are the following popular brand-name products:

Each of these have been approved by the FDA to assist in the prevention of pregnancy for women who have chosen the route of oral contraception. However, many women use them to reduce the symptoms associated with premenstrual dysphoric disorder (PMDD) and moderate bouts of acne.

Unfortunately, each of these birth control pills has recently been linked to the development of serious side effects. Of notable concern, however, are two recently published studies that evaluated the risk of venous thromboembolism (VTE) in women who use birth control pills that contain drospirenone. VTE is characterized as a blood clot that forms deep within a vein. According to these studies there is a greater risk of VTE associated with birth control pills that contain drospirenone.

Further complicating the already ambiguous situation, were the opinions of several healthcare officials at an FDA Advisory Committee. According to members of the committee, drospirenone-containing birth control pills may significantly increase the risk of unnecessary blood clotting. It has been suggested that drospirenone has a propensity to increase blood potassium levels beyond that of standard ratios. Furthermore, a significant increase in potassium may trigger the clotting cascade phenomena.

While blood clots are considered a natural safety mechanism to prevent the displacement of blood, their unnecessary presence may prove to be dangerous. Should a significant blood clot develop, it can interfere with the flow of blood through the circulatory system. Subsequently, the obstruction may prevent organs from receiving the nutrients they require to survive and function. Should this happen, the following complications may occur:

  • 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 the manufacturers of drospirenone-containing contraceptives to revise their labels to include the new risks. According to a recent 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 oral contraceptives will be receiving a similar revision to their professional labels, in order to indicate their increased risk of unnecessary blood clotting:

  • Ocella
  • Gianvi
  • 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.