FDA Evaluating Increased VTE Risk Associated with Yasmin, Yaz Birth Control Pills
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
Many medications have side effects or potential risks. Consumers must be told about these risks and doctors must weigh the beneficial effects of using medications against the possible risk of side effects when prescribing medications to patients. The problem arises when manufactures know a drug may be dangerous, but doesn't warn medical professionals or the public of the potential dangers associated with using the drug. When this occurs, people can be injured.
Recent studies have been conducted on the birth control medication known by the brand names Yasmin or Yaz, results were published in the British Journal of Medicine in April 2011. Both studies looked at groups of women between 15 and 44 who were taking birth control pills containing drospirenone or levonorgestrel. According to the studies, users of the birth control medications containing drospirenone (such as Yasmin or Yaz) have an increased risk for developing blood clots, known as venous thromboembolism (VTE). In fact, the research revealed that although the risks of developing VTE from using oral contraceptives is low, women taking drospirenone-based pills were two to three times more at risk of developing the dangerous blood clots then women taking levonorgestrel-based pills.
FDA Investigating Risks
There have been previous studies conducted on birth control pills containing drospirenone, six in total as reported by NPR news. The results of these studies are at issue and raising red flags for the U.S. Food and Drug Administration (FDA). Four of the six studies have had similar findings regarding the increased risk of VTE in women using drospirenone-based birth control pills. However, two of the studies have not shown an increased risk. In response to the conflicting results, a safety alert has been issued on the oral contraceptive medication by the FDA.
The safety alert aimed at these types of birth control medications indicated that the FDA will be examining the study results to determine the level of risk to consumers. The FDA has not issued a ban on these medications nor are they advising women to discontinue their use. The alert is suggesting that women who are taking Yasmin, Yaz or a generic form of the medication (such as Beyaz, Zarah, Syeda, Safyral, Ocella, Loryna and Gianvi) speak to their doctor about using or discontinuing using the birth control pills. The FDA also recommends that any women currently taking birth control pills containing drospirenone be aware of the symptoms of venous thromboembolism and see a doctor immediately if any of the symptoms are present.
As a result of the study findings on increased risk of VTE in women using oral contraceptives, the FDA will be conducting their own study on the risks and is expected to release their findings this summer.
Why is VTE Dangerous and What are the Symptoms?
Venous thromboembolism is when the blood clots within the vein. The blood clot can lead to other medical conditions such as deep vein thrombosis, when the clot is in the legs or pelvis, or pulmonary embolism when a clot travels to the lungs and blocks the pulmonary artery. Both conditions can result in complications, long-term medical care and in some serious cases, even death. One great danger associated with a VTE condition is that it can be very difficult to diagnose. That is why it is imperative for women taking drospirenone-based birth control pills, who may be at a higher risk of developing VTE, to know the symptoms. Warning signs and symptoms often affect the legs or lower extremities and may include:
- Constant pain
- Skin discoloration
Chest pain, rapid pulse and shortness of breath can also be warning signs of pulmonary embolism. If any of these symptoms are present, it is important to seek immediate medical treatment.
If you have been injured by using Yasmin, Yaz or a generic drospirenone-based birth control pill, you may be entitled to compensation for your injuries. Drug companies are responsible for the medications they sell to the public. These products must be safe and warnings must be issued for any potential risks. If a drug company fails to meet this standard and consumers are injured as a result, the company may be liable for those injuries. Speak to a products liability attorney experienced in drug injury cases to discuss your situation, explain your legal options and help you hold the drug company accountable for your injuries.