Another Generic YAZ Birth Control Pill Is Approved, Just One Week Before FDA Drug Safety Meeting

Coincidence, But Ironic, Given Several Recent Medical Studies Which Suggest Drospirenone (DRSP) Causes Blood Clots

(Posted by Tom Lamb at DrugInjuryWatch.com)

On November 29, 2011 Watson Pharmaceuticals issued this press release, "Watson's Generic Yaz(R) Receives FDA Approval", which begins as follows:

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Vestura(TM) (3 mg drospirenone and 0.02 mg ethinyl estradiol), a generic version of Bayer's Yaz(R) oral contraceptive product.

The timing of this drug approval by the FDA for another drospirenone-containing birth control pill, while seemingly only coincidental, is quite ironic given that next week, on December 8, 2011, there will be Joint Meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee which has as its subject the safety of this relatively new progestin drospirenone (DRSP). 

From the FDA announcement for this December 2011 FDA advisory committees meeting about DRSP birth control pills:

Agenda

The committees will discuss the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel. Drospirenone-containing oral contraceptives for the primary indication of pregnancy prevention include: YASMIN, YAZ (drospirenone/ethinyl estradiol tablets), BEYAZ, SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), Bayer HealthCare, and the generic equivalents for these products.

Of course, many people (with different interests, no doubt) are anxious to hear the discussions about the drospirenone-containing birth control pills at this joint FDA advisory committees meeting next week.

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Until then, and perhaps to provide some relevant background information, I leave you with this list of relatively recent articles I have written about the drug safety issues associated with YAZ, Yasmin, Ocella, Gianvi, Zarah, Loryna, Syeda, Beyaz, Safyral, and Vestura:

• Two More Medical Studies Show Increased Risk Of Blood Clots With Use Of YAZ, Yasmin, And Ocella -- Researchers Find Drospirenone (DRSP) Containing Birth Control Pills Increased Risk Of Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)
• YAZ / Yasmin / Ocella Update: October 2011 FDA Study Finds Increased Risk Of Blood Clot Side Effects Like DVT, PE, Stroke, And Heart Attack -- Safety Study Findings About Drospirenone (DRSP) Birth Control Pills Will Be On The Agenda For FDA Advisory Committees At Joint Meeting In December 2011
• YAZ / Yasmin / Ocella / Beyaz / Safyral: Drug Safety Regulators Focus On Blood Clot Side Effects -- EMA Orders New Warning About Risk Of Venous Thromboembolism, While FDA And Health Canada Begin Safety Review

Of course, we will report about the presentations and discussions at this FDA meeting about the safety of drospirenone (DRSP) after we get back to the office.

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