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EMA Denies Approval of Yaz for Moderate Acne

On April 19, 2012, the European Medicines Agency (EMA) denied approval for Yaz birth control pills to be marketed as a treatment for moderate acne, because they were concerned that young women would choose to treat their acne with Yaz when there were other, safer acne treatments.

In a statement, the Agency’s Committee for Medicinal Products for Human Use (CHMP) stated: “women not seeking contraception would therefore be unnecessarily exposed to the risks of Yaz … when alternative acne treatments are available.”

Yaz birth control pills contain a combination of two synthetic hormones: drospirenone and ethinyl estradiol. Unfortunately, several massive studies have found that drospirenone, an ingredient in Yaz, has been linked to as much as a three-fold increased risk of blood clots. Yaz is no more effective at preventing pregnancy than other birth control pills.

Blood clots can cause Venous Thromboembolism (VTE), a severe medical condition that occurs when blood clots form inside veins located deep inside the body. When these blood clots break loose, they can cause a severe, life-threatening pulmonary embolism, heart attack, or ischemic stroke. Bayer HealthCare Pharmaceuticals, Inc., is already facing thousands of Yaz lawsuits from women who were severely injured after taking this medication.

Despite these risks, Yaz birth control pills are approved in all European Union Member States except Hungary. When the manufacturers of Yaz in the EU applied to change the drug’s approval to include “treatment of moderate acne vulgaris only in women seeking oral contraception,” the Member States were unable to agree on the new indication. They referred the dilemma to the CHMP for arbitration.

The CHMP concluded:

“Therefore, based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP considered that the benefits of Yaz … did not outweigh their risks in the proposed new indication. The Committee concluded that the variation to the marketing authorisations for these medicines cannot be approved.”

Do I Have a Yaz Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Yaz lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has suffered from severe side effects after taking Yaz, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

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