Yasmin/Yaz Linked to Life-Threatening Blood Clots
By Robert J. Boumis
Yaz and Yasmin were originally hailed as flagship birth control pills by their manufacturer, Bayer. These drugs were considered the third generation of oral, hormone-based contraceptives. However, serious, life-threatening risks have been linked to Yasmin and Yaz.
These birth control pills are based on a new synthetic progestin called drospirenone. This drug works similarly to other hormone-based contraceptives in that it discourages the body from releasing an egg, an effects other changes on a woman’s body that discourage pregnancy. However, it appears that drospirenone increase the serum levels of potassium, which can alter blood chemistry in such a way as to encourage the formation of blood clots. Yasmin was approved in 2001, and Yaz was approved in 2008. Both are variations on drospirenone-based drugs.
The first troubles with Yaz and Yasmin stemmed from their advertising. According to a 2008 letter from the United States Food and Drug Administration, there were problems with the way Bayer marketed Yaz. The FDA had two primary complaints. First, they felt that the commercials “broadened the indications of Yaz.” Specifically, they felt that “the TV Ads misleadingly overstate the efficacy of the drug.” The FDA’s letter explained that the studies on Yaz indicated that it reduces acne and symptoms of Premenstrual Dysphoric Disorder (PMDD), but did not eliminate them entirely, while the commercials implied a complete resolution of symptoms. The FDA also felt that the commercials had distracting visuals while the announcer read off the potential risks associated with Yaz. The FDA felt this downplayed the risks associated with this drug.
The FDA has ongoing post-market surveillance of Yaz, like all drugs. In April of 2010, the FDA released a change to their packaging of Yaz, indicating that some studies had found a link between Yaz and an increased risk of blood clots. This link was found by a retrospective cohort study.
Later, in March of 2012, the FDA release yet another change to the warnings and information that come with Yaz. Now, based on further research, the FDA advised patients of a higher risk of thrombosis (blood clots) when using Yaz, particularly in the first year of use.
Since 2008, these contraceptives have carried a black box warning. A black box warning is the highest level of warning the FDA can mandate for a prescription drug. Black box warnings are designed to inform the patient and prescribing physician that a particular drug carries a high risk of serious, life-threatening adverse reactions.
Thousands of drug injury lawsuits have been filed against Bayer by victims of Yasmin/Yaz blood clots. These lawsuits have taken the form of a multi-district litigation or MDL. An MDL is very similar to a class action lawsuit. However, in an MDL individual plaintiffs often retain their own legal council, whereas there is usually only a single lawyer, or team of lawyers, helming a class action lawsuit.
Lawsuits in the Yasmin/Yaz MDL allege that Bayer knew, or should have known about the risks associated with their product. The lawsuits further allege that Bayer downplayed these risks, preventing patients and their prescribing physicians from having the information they needed to make an informed decision regarding their medical care. The lawsuits seek damaged related to thrombosis events suffered after the plaintiffs took Yaz or Yasmin.
If you or a loved one took Yaz and then suffered a thrombosis event, you may feel overwhelmed, and not sure where to turn next. But you do have rights, and there are steps that you can take to regain control over your life. You can start by visiting the Yaz/Yasmin, Beyaz & Ocella Birth Control Pill Class Action Lawsuit Settlement & Investigation. Here, you can enter your information for a free initial consultation by a lawyer who specializes in this type of lawsuit. From here, you may receive additional guidance on the next steps that you can take in your specific situation.
Updated May 23rd, 2013
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