Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Article 1 - Creating a Clinical Disorder for Profit
Article 2 - The Devastating Side Effects
Article 3 - Are the Current FDA Label Warnings Enough?
The first article of my blog series on Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz discussed how Yaz in particular was marketed to treat premenstrual dysphoric disorder (PMDD)--before PMDD was even classified as a medical condition--so that the drug manufacturer, Bayer, could increase their profits.
In this article, I will provide information on the prescription of birth control pills that contain drospirenone (DRSP), such as those listed above, and the devastating side effects that can result from using them.
While Yaz, Yasmin, Gianvi, and Beyaz are approved to treat PMDD, none of the DRSP-containing birth control pills are approved by the FDA to treat PMS symptoms. In fact, the trials conducted by the company showed that these DRSP-containing drugs are scarcely more effective than a placebo.
However, that certainly didn't stop Bayer from marketing them as such. The FDA responded by issuing a warning letter against Bayer in 2008, stating that they were falsely advertising that Yaz could be used to treat and completely eliminate symptoms of PMS.
Not only did Bayer market Yaz to treat a condition that it was not approved for, but they also claim that the DRSP birth control pills they manufacture do not increase the risk of blood clots, though the medical evidence strongly suggests otherwise.
For example, in 2009, the studies "The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type" and "Hormonal contraception and risk of venous thromboembolism" showed that use of DRSP-containing birth control pills do, in fact, lead to an increased risk of blood clots.
Here is an excerpt from the "Results" section of the first article's abstract:
Currently available oral contraceptives increased the risk of venous thrombosis fivefold compared with non-use (odds ratio 5.0, 95% CI 4.2 to 5.8). The risk clearly differed by type of progestogen and dose of oestrogen. The use of oral contraceptives containing levonorgestrel was associated with an almost fourfold increased risk of venous thrombosis (odds ratio 3.6, 2.9 to 4.6) relative to non-users, whereas the risk of venous thrombosis compared with non-use was increased...6.3-fold for drospirenone (6.3, 2.9 to 13.7). [Emphasis added].
The "Conclusion" section of the second article's abstract provides the following information:
The risk of venous thrombosis in current users of combined oral contraceptives decreases with duration of use and decreasing oestrogen dose. For the same dose of oestrogen and the same length of use, oral contraceptives with desogestrel, gestodene, or drospirenone were associated with a significantly higher risk of venous thrombosis than oral contraceptives with levonorgestrel.
Furthermore, according to the article, "Lawsuits Follow PMDD Diagnosis: Lowering the Bar," in 2012, "an FDA safety review found that the birth control drugs might increase the risk of blood clots by as much as threefold, compared with other hormonal birth control pills."
Here is a current list of side effects that have been associated with birth control pills that contain DRSP:
- Blood Clots
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism (PE)
- Cerebrovascular Accidents (CVA)
- Heart Attack
- Myocardial Infarction
Have you experienced any of these side effects after using Yaz, Yasmin, Ocella, Gianvi, Safyral, or Beyaz? If so, tell us about it by leaving a comment, or by completing a free case evaluation.
The final article in this series will discuss the current FDA drug label warnings concerning these side effects, and whether such warnings are sufficient.
In the meantime, we will continue to monitor the medical literature on Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz. You can also learn more about these DRSP-containing birth control pills on our website.
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