Birth Control with “Cure All” Promises and Life Altering Side Effects
By: Brandy Robertson
Many young women may remember the Yaz and Yasmin birth control advertisements from a few years ago that featured fashionable young women sitting around in an upscale club discussing Yaz or Yasmin birth control. Or they may remember the one where the theme song “We’re Not Gonna Take It” is playing while young women kick or pop balloons labeled “irritability,” “feeling anxious,” “moodiness,” “headache,” or “fatigue” – all symptoms of premenstrual syndrome or PMS. These symptoms are all a normal part of the menstrual cycle. Yaz, Yasmin and its generic equivalent Ocella were wrongly marketed to women suffering from PMS.
Index
- Yaz/Yasmin for PMDD
- Yasmin and Yaz’s dangerous effect on potassium levels
- Yaz and Yasmin increases risk of blood clots
- Bayer faces FDA and Yaz lawsuits
- Get Help
Yaz/Yasmin for PMDD
The Yaz/Yasmin Patient Package Insert notes that the medication “has not been shown to be effective for the treatment of PMS.” It is however, indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD) – which is a very severe disorder that interferes with work, social activities or relationships. The symptoms of PMDD include decreased interest in usual activities, difficulty concentrating, lack of energy, anxiety or tension, persistent anger or irritability. This disorder can only be diagnosed by a healthcare provider based on very specific criteria.
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In October 2008, the Food and Drug Administration issued a warning letter to Bayer HealthCare Pharmaceuticals – the manufacturer of Yaz and Yasmin – indicating that their television advertisements were “misleading because they broaden the drug’s indication, overstate the efficacy of Yaz and minimize serious risks associated with the use of the drug.” Bayer was not only advertising Yaz and Yasmin as a birth control option, it was also advertising it as a treatment for acne and the normal symptoms of PMS, all the while diminishing the serious and potential life-threatening side effects.
Yasmin and Yaz’s dangerous effect on potassium levels
Yasmin and Yaz are considered “fourth-generation” birth control pills and are a combination of the hormones Ethinyl Estradiol and Drospirenone. Drospirenone is a new formulation of synthetic progesterone. Some form of progesterone is found in all birth control pills; however, the new formulation Drospirenone is closely related to Spironolactone, which is a diuretic. Because of its diuretic properties Drospirenone can increase potassium to a dangerous level if not properly monitored. The dosage of Drospirenone contained in Yaz, Yasmin and Ocella is equivalent to a 25 mg dose of the diuretic Spironolactone. Yaz, Yasmin and Ocella should not be used by individuals with liver, kidney or adrenal disorders.
Yaz and Yasmin increases risk of blood clots
In addition to increasing potassium levels, studies have shown that Yaz, Yasmin and Ocella also cause an increased risk of causing blood clots. A study published by the Food and Drug Administration showed that birth control pills containing Drospirenone – such as Yaz, Yasmin and Ocella – showed a 74% increase in blood clots, deep vein thrombosis or pulmonary embolism. Once blood clots form, they can cause severe injuries or death by traveling through the body to the brain, heart or lungs. When compared to other forms of progesterone containing birth control, the risk of clotting events with a birth control pill containing Drospirenone is much greater.
Bayer faces FDA and Yaz lawsuits
Yaz and Yasmin have been one of the most popular birth control pills on the market resulting in sales of $616 million during 2008. Between the years of 2007 and 2010, the manufacturer of the drug spent an astounding $270 million dollars on advertising alone. As a result of the misleading direct-to-consumer advertisements, Bayer was ordered by the Food and Drug Administration to spend a mere $20 million on corrective advertising to address the off label use and the “cure all” marketing claims.
In addition to the corrective advertising, Bayer was also facing numerous lawsuits due to the misleading advertising and severe injuries caused by their products. In 2009 the Judicial Panel on Multi-District Litigation set up MDL-2100 and transferred all cases to the United States District Court for the Northern District of Illinois. This Court is the lead Court designated for handling the Yaz, Yasmin and Ocella lawsuits. Currently, all trials and court deadlines are on hold pending settlement negotiations with plaintiffs’ attorneys and representatives for Bayer. In a July 31, 2012, newsletter Bayer announced that it had settled about 1,900 cases totaling $402.6 million. The company has set aside $610.5 million dollars to settle the remaining cases.
Get Help
If you or anyone you know has suffered serious injuries while taking Yaz, Yasmin, Ocella or any other Drospirenone-containing birth control, please contact the law firm of Heninger Garrison Davis, LLC at 800-241-9779 or 205-326-3336.
