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?
In the previous article of my blog series on Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz, I discussed the devastating side effects that can result from using these DRSP-containing birth control pills.
For my final article in this series, I will discuss the current drug label warnings for these drugs, and contemplate whether these warnings are sufficient.
As discussed in my previous article, studies conducted in 2009, as well as the FDA findings in 2012 led to a label change for the DRSP-containing birth control pills. The 2012 drug label warned that the risk of venous thromboembolism (VTE) is greater among those who use DRSP-containing birth control pills such as Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz.
In spite of this new warning, there have been "more than 10,800 adverse events reported to [the] FDA by health professionals and manufacturers" concerning DRSP birth control pills, according to the article, "Lawsuits Follow PMDD Diagnosis: Lowering the Bar." Furthermore, 6,000 of those reports involved hospitalizations, and 200 reports involved deaths.
Unfortunately, tragic stories of women using these DRSP birth control pills are far from scarce. One woman's story is discussed in the aforementioned article, and involves twenty-nine year-old, Oconomowoc native, Cayla Hibbard. Hibbard took Yasmin as a means of birth control and alleviating severe menstrual symptoms. When she started taking Yasmin, Hibbard lived an active lifestyle and was going to school for massage therapy.
However, one day, she was hospitalized after experiencing difficulty breathing while climbing stairs. She was diagnosed with a pulmonary embolism, which is a potentially fatal blood clot in the lungs. As a result, Hibbard had to use blood thinning medications for approximately six months after her diagnosis.
Hibbard filed a lawsuit against Bayer claiming that they "knew or should have known that Yasmin was being used to treat menstrual symptoms, even though it is not approved for that. The lawsuit also argued the company fraudulently concealed the safety risks of the drug in order to induce doctors to prescribe it."
There are thousands of women like Hibbard who have also experienced devastating side effects after using these DRSP birth control pills. While Hibbard survived this terrible episode, other women who used these birth control pills have not been so fortunate. Since the late 2000s, more than 12,000 women in America have filed lawsuits against Bayer for injuries or deaths resulting from use of Yaz and Yasmin, alone. In addition, many more lawsuits have been filed against Bayer by women who used Safyral, Beyaz, Ocella, and Gianvi for similar devastating side effects.
Given that such a large number of women are still suffering from life-threatening side effects resulting from DRSP birth control pills, it may be time for the FDA to strengthen their warnings. It seems as though the warnings added to the drug labels for the DRSP birth control pills in 2012 are not sufficient. How many more women need to suffer before the FDA releases a new label change, bearing stronger warnings?
Do you have a story similar to Cayla Hibbard, and the thousands of other women who have suffered due to Yaz, Yasmin, Ocella, Gianvi, Safyral, or Beyaz? Tell us about it by leaving a comment, or by completing a free case evaluation.
We will continue to monitor the medical literature concerning Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz, and hope to see a new label change in the near future for these birth control pills.
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