Parker Waichman LLP Commends FDA Directive that Labels for Yaz, Yasmin and Other Drospirenone Birth Control Pills Include New Information Regarding Blood Clot Risks

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According to the FDA, the new labels for Yaz, Yasmin and similar oral contraceptives will state that some studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to those made with other progestins.

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The modified label will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for Yaz, Yasmin and similar birth control pills.

Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective drugs, commends the U.S. Food & Drug Administration (FDA) on their directive that labels for Yaz, Yasmin and other birth control pills made with the synthetic progestin, drospirenone, be updated to include stronger information regarding their association with a risk of serious blood clots. According to an FDA Drug Safety Communication issued today, the modified label will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk, which suggested an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing products compared to users of other hormonal contraceptives. [fda.gov/Drugs/DrugSafety/ucm299305.htm]

In addition to Yaz (drospirenone 3 mg and ethinyl estradiol 0.02 mg) and Yasmin (drospirenone 3 mg and ethinyl estradiol 0.03 mg), the new blood clot information will be added to the labels of all drospirenone-containing contraceptives, including:

  •     Beyaz (drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg)
  •     Drospirenone and Ethinyl Estradiol (drospirenone 3 mg and ethinyl estradiol 0.03 mg)
  •     Drospirenone and Ethinyl Estradiol (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
  •     Gianvi (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
  •     Loryna (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
  •     Ocella (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
  •     Safyral (drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg)
  •     Syeda (drospirenone 3 mg and ethinyl estradiol 0.03 mg)
  •     Zarah (drospirenone 3 mg and ethinyl estradiol 0.03 mg)

Blood clots can trigger heart attacks, strokes and blockages in the lungs or blood vessels, so even a slightly increased risk can have serious consequences for young women taking Yaz, Yasmin and other drospirenone-containing birth control pills. In light of this public health threat, Parker Waichman LLP is pleased to see that the FDA has decided to provide young women who use Yaz, Yasmin and similar birth control pills with this vital information.

More than 10,000 lawsuits have been filed against Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG, and other makers of drospirenone-containing birth control pills by women who claim to have suffered blood clots, deep vein thrombosis (DVT), pulmonary emboli, gallbladder disease/removal, stroke, death and other serious injuries after taking these medications. The majority of these lawsuits have been consolidated in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) currently pending before the Honorable Judge David R. Herndon in the United States District Court for the Southern District of Illinois.

Parker Waichman LLP continues to offer free legal evaluations to victims of drospirenone contraceptives, including Yaz and Yasmin. If you or a loved one has suffered blood clots, deep vein thrombosis (DVT), pulmonary emboli, gallbladder disease/removal, stroke, death and other serious injuries while taking one of these birth control pills, please visit the firm's Yaz and Yasmin injury page at http://www.yourlawyer.com.

For more information regarding Yaz and Yasmin lawsuits and Parker Waichman LLP, please visit: http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).

Contact: Parker Waichman LLP
Herbert Waichman, Partner
(800) LAW-INFO
(800) 529-4636
http://www.yourlawyer.com

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Herb Waichman, Partner
Parker Waichman LLP
(800) 529-4636
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