Yasmin and Yaz Lawsuit Help
The Weinberg Law Firm has represented hundreds of individuals and thousands more class action claimants injured by the side effects of well known prescription drugs including Vioxx, Ortho Evra, Baycol, and blood clotting products. We are ready to help you. If you have suffered a heart attack, stroke, pulmonary embolism (PE), deep vein thrombosis (DVT), or other serious side effect as a result of taking Yaz, Yasmin, Beyez, or Ocella birth control pills and have a question concerning your legal rights, please call us toll free at 1-877-934-6274.
FDA Announces that Birth Control Pills Containing Drospirenone May Increase the Risk of Blood Clots
In a Drug Safety Communication dated April 10, 2012, the FDA announced that after completing its review of multiple epidemiologic studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills, it had concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.
According to the FDA, the labeling for Yaz, Yasmin, Beyez, and Safyral should be revised to reflect that epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing birth control pills when compared to products containing levonorgestrel or some other progestins. The revised labeling would also reflect that some epidemiological studies found no additional risk of blood clots with drospirenone-containing birth control pills.
Why Are Yasmin And Yaz (drospirenone/ethinyl estradiol tablets) Prescribed?
Yasmin and Yaz are widely prescribed oral contraceptives used to prevent pregnancy. Both are manufactured by Bayer HealthCare.
Yasmin and Yaz are combination birth control pills containing two types of hormones known as estrogen and progestin. The estrogen component, ethinyl estradiol, is common to many combination birth control pills, however, the progestin component, drospirenone, is unique to Yasmin and Yaz. Yasmin contains a higher concentration of ethinyl estradiol per tablet than Yaz.
Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.
Yaz is indicated for the:
- prevention of pregnancy in women who elect to use an oral contraceptive,
- treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception, and
- treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Yaz should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
Yasmin and Yaz Side Effects
Some of the side effects of Yaz and Yasmin may include heart attack, stroke, pulmonary embolism, gall bladder disease, deep vein thrombosis, and death. Drospirenone poses an additional risk for serious heart and health problems, because it can cause hyperkalemia (increased potassium levels), especially in women taking certain drugs in combination with Yaz and Yasmine, and in women with conditions that may predispose them to hyperkalemia. See YAZ
FDA Warning Letter
Yasmin and Yaz became top earners for Baxter HealthCare, through the company’s multimillion dollar ad campaigns promoting the drugs as “a pill that went beyond birth control.” The U.S. Food and Drug Administration (FDA) could not have disagreed more.
In October of 2008, the FDA sent a Warning Letter to Bayer HealthCare stating that two of the company’s television ads were misleading because they broadened Yaz’s indication (use), overstated its efficacy, and minimized the serious risks associated with the use of Yaz.
For example:
- By not using the term PMDD (see above), Bayer commercials suggested that Yaz is appropriate for treating women with the more common and less serious set of symptoms known as premenstrual syndrome, PMS. Printed labeling for Yaz states that it has not been evaluated for the treatment of PMS, however, the television ads failed to communicate that limitation to consumers.
- The ads suggested that Yaz is approved for the treatment of acne of all severities while it has only been approved for the treatment of moderate acne vulgaris.
- The FDA stated that the commercial’s distracting visuals, graphics, and music made it difficult for consumers to comprehend the serious and even life-threatening side effects that were required to be disclosed during the commercials, suggesting misleadingly that Yaz is safer than experience has shown it to be.
The FDA concluded that these ads misbranded Yaz in violation of the Federal Food, Drug, and Cosmetic Act, thereby exposing young women to health risks by encouraging the use of Yaz under conditions for which the drug was not approved, over-promising the drug’s benefits, and minimizing the risks associated with the use of Yaz.
What You Should Do If You Suspect Yaz Or Yasmin Side Effect Injury
Consumers and professionals can report suspected Yaz and Yasmin side effects, or product quality problems to the FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm, or by phone 800-FDA-1088.
Contact the Law Firm of Eric H. Weinberg for a Free Yaz/Yasmin Law Lawsuit Evaluation
If you or a loved one were injured as a result of Yasmin, Yaz, Beyez, or Ocella birth control pills, please call our firm toll free at 1-877-934-6274 to learn about your legal rights. Since 1988, the Weinberg Law Firm has represented hundreds of individuals injured by defective drug and medical device products. The firm has played a leading role in the litigation of high-profile drug lawsuits including Vioxx, Baycol, and blood products, recovering over $800 million on behalf of the firm’s clients.
