Yaz Risks and Complications
Yaz is a birth control with the active ingredients drospirenone and ethinyl estradiol. While ethinyl estradiol is a synthetic estrogen common in birth control pills, Drospirenone was only recently approved by the Food and Drug Administration. The FDA first allowed a birth control pill with drospirenone to come to the market in 2001. This pill, manufactured by a U.S. affiliate of Bayer Schering called Berlex Laboratories Inc., was followed by the approval of Yaz in 2006. Yaz, like Yasmin, contained drospirenone, but the number of active pills was different as Yaz had 24 active pills as compared with 21 active pills in a Yasmin cycle.
Drospirenone promised to be a new generation of synthetic progesterone with anti-androgenic properties. Yaz and similar birth control options including Yasmin, Ocella and Beyaz, were described as the “ultimate” birth control solution because the pills were supposed to provide less fluctuation in hormones between cycles; and were supposed to be useful treatments for severe PMS and acne.
Unfortunately, it turned out that Yaz and other birth controls with drospirenone may cause significant and serious complications and may not provide the benefits promised. More than 10,000 claims have been filed against makers of drugs containing drospirenone, including Yaz, Ocella, Yasmin and Beyaz. The Law Offices of Jeffrey S. Glassman can help those patients who trusted Bayer’s marketing of Yaz and who experienced side effects.Bayer Misleads the Public About Yaz Birth Control
Yaz was marketed aggressively when it was released, and in both 2008 and 2009, Yaz was the best selling birth control pill on the U.S. market.
Unfortunately, problems with Yaz began to surface shortly after the medication came onto the market, and the FDA soon investigated whether Bayer was being misleading in its advertising and in the promises the company was making. The investigation determined that Yaz wasn’t fulfilling its promises and Bayer paid more than $20 million in 2008 to advertise dangers to the public in order to settle FDA complaints that the advertising regarding the birth control pill was misleading.
The FDA chastised Bayer for overstating the effectiveness of the drug; minimizing information about the risks; and incorrectly implying that Yaz was a cure for premenstrual dysphoric disorder. In 2009, the FDA added to its complaints, indicating that the company was improperly implying that Yaz could be used as a cure for acne.Yaz Birth Control Proves Dangerous
While Bayer’s overstatement of the benefits of Yaz may have prompted many patients to switch to this method of birth control, this misleading marketing wasn’t the biggest problem with the pills. Yaz has also been linked to serious potential side effects including:
- Thromboembolism: An increased risk of developing blood clots.
- Deep vein thrombosis: An increased risk of blood clots in the legs.
- Pulmonary embolism: Blockages in the lungs.
- Cardiovascular risks including an increased chance of heart attack and arrhythmia.
- Gallbladder disease
- Upper respiratory infections
- Stomach problems
- Irregular bleeding outside of the normal menstrual cycle
- Decreased sexual desire
- Elevated blood pressure
- Problems with blood sugar
- Skin darkening
- A severe allergic reaction
- Sudden death
Because of the serious complications, the FDA required an update in 2010, mandating that the label reflect the increased risk of blood clots and vascular problems associated with Yaz. The label was changed again in March of 2011 to better reflect the blood clot risk, but this change was still found insufficient by an FDA advisory panel vote of 21-5. The panel believes that the label still does not provide sufficient warning to patients that the side effects of Yaz are potentially fatal.Getting Help From a Yaz Lawyer
If you or a loved one experienced any complications or side effects resulting from Yaz birth control, or from related products such as Yasmin, it is important to understand your legal rights. An experienced Boston defective drug lawyer at the Law Offices of Jeffrey S. Glassman can help you to pursue a claim for compensation. Give us a call or contact us online today to learn more.