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Birth Control Blood Clot Safety Update

The U.S. Food & Drug Administration (FDA) has issued a press release informing the public that it is continuing to analyze data concerning the increased risk of blood clots with the use of contraceptive products containing drospirenone. Preliminary results of an FDA-funded study suggest a 1.5-fold increase in the risk of blood clots for women who use birth control pills that contain drospirenone compared to users of other types of contraceptives. In order to better assess this risk, the administration has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011.

Drospirenone Blood Clot Update 4/10/12: Birth control products containing the synthetic hormone drospirenone have been linked to an increased risk for blood clots, according to a warning issued today by the U.S. Food & Drug Administration (FDA). In response to these findings, the FDA has required that all drospirenone-containing contraceptives carry warnings which state that several studies have found as much as a three-fold increased risk of blood clots associated with drospirenone when compared to levonorgestrel, a different hormone found in many older forms of birth control.

Free Birth Control Blood Clot Lawsuit Evaluation: If you or a loved one suffered a blood clot after taking birth control products, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

What’s the problem?

September 28, 2011 – The Food & Drug Administration has reviewed six published epidemiological studies that analyzed the risk of a type of blood clot known as venous thromboembolism (VTE) in women using contraceptives containing drospirenone. These studies have reported markedly different results.

Two studies involved postmarketing research that did not report any difference in VTE risk between drospirenone-containing drugs and those containing levonorgestrel or other progestins. However, two other independent studies published in 2009 reported a 1.5 to 2-fold increased risk of VTE in women who used drospirenone compared to those who used levonorgestrel. More recently, two articles published in the British Medical Journal (BMJ) reported a 2 to 3-fold greater risk of blood clots in women using oral contraceptives containing drospirenone. Due to these conflicting results, the FDA has not yet reached a conclusion about the actual risks of drospirenone, but has stated that it remains concerned about the issue and will continue to monitor the events surrounding it closely.

Which Birth Control Pills Contain Drospirenone?

Brand names of drospirenone-containing birth control products include:

  • Yaz (generics Gianvi and Loryna)
  • Yasmin (generics Ocella, Syeda and Zarah)
  • Beyaz
  • Safyral

Preliminary figures from an FDA-funded study exploring the link between drospirenone and blood clots appear consistent with results from the 2009-2011 published studies. And though the administration’s review is ongoing, the initial data seems to be consistent with an approximately 1.5-fold increase in the risk of blood clots for drospirenone users compared to users of other types of oral contraceptives. To illustrate this point, if the risk of developing a blood clot among women using other birth control pills is about six per 10,000, then the risk of developing a blood clot with drospirenone would be about 10 in 10,000. These figures, along with the completed review of the results of the study, will be presented at the meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in December 2011.

The FDA is advising patients to talk to their doctors about their risk of blood clots before deciding which contraceptive to take. Known factors that increase the risk for blood clots include:

  • Smoking
  • Obesity
  • Family history of blood clots
  • Other factors that contraindicate use of birth control pills

If you come to find that your contraceptive contains drospirenone, do not stop taking it without first consulting your doctor. Be sure to discuss any questions or concerns you might have about your contraceptive with your healthcare provider thoroughly.

How Does Drospirenone Cause Blood Clots?

Drospirenone may be responsible for inducing concentrated levels of potassium in a patient’s bloodstream. While potassium is essential for the proper functioning of the body, elevated levels can be dangerous, and can lead to a blockage in the bloodstream. Women who use contraceptives containing drospirenone may be at a greater risk of developing a stroke, heart attack or venous thromboembolism (blood clot) because of this blockage. VTE is a condition in which a blood clot (thrombus) forms in one or more of the deep veins in the body, most often in the legs. It is a serious condition because a blood clot that has formed in a vein can break loose and travel to the lungs, which has the potential to cause a heart attack or stroke.

Drospirenone Side Effects

In addition to being linked to blood clots and venous thromboembolism (VTE), drospirenone has also been linked to the following side effects:

  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism (PE)
  • Hyperkalemia
  • Stroke
  • Cerebrovascular Accidents (CVA)
  • Heart Attack
  • Myocardial Infarction
  • Gallbladder Disease / Injury (cholecystitis)
  • Gallbladder Removal (cholecystectomy)
  • Death

Nationwide, drugmakers face thousands of lawsuits alleging that the companies failed to adequately warn the public about the increased risk of health problems associated drospirenone. The claims have been filed by women who have allegedly suffered from blood clots and other serious injuries after using drospirenone birth control pills.

Do I Have a Birth Control Blood Clot Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in birth control lawsuits. We are handling individual litigation nationwide and currently accepting new blood clot cases in all 50 states.

Free Confidential Case Evaluation: Again, if you developed a blood clot after using birth control, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.

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