Loryna Lawsuit

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Loryna Background

Approved by the U.S. Food & Drug Administration (FDA) for use in females who have started their menstrual cycle, Loryna (drospirenone / ethinyl estradiol) is the generic version of the birth control drug Yaz. Sold by Sandoz, Inc., Loryna is prescribed to prevent unwanted pregnancy, and is also commonly used to treat acne and premenstrual dysphoric disorder. It may also be used in an ‘off-label’ capacity to treat heavy, irregular or painful periods.

Loryna is designed to prevent pregnancy by stopping ovulation, changing the cervical mucus, and altering the lining of the mucus. Just like any medicine, Loryna may cause side effects. However, Loryna has been associated with a number of potentially life-threatening cardiovascular events that should be addressed by users before continuing to take the medication.

Loryna Side Effects

Loryna contains drospirenone, which has been associated with adverse side effects such as:

  • Blood Clots
  • Deep Vein Thrombosis (DVT)
  • Venous Thromboembolism (VTE)
  • Pulmonary Embolism (PE)
  • Stroke
  • Cerebrovascular Accidents (CVA)
  • Hyperkalemia
  • Heart Attack
  • Myocardial Infarction
  • Gallbladder Disease / Injury (cholecystitis)
  • Gallbladder Removal (cholecystectomy)
  • Death

Yaz Label Change

On March 11, 2011, the FDA ordered Bayer HealthCare Pharmaceuticals to change the labeling for Yaz to reflect the risk for thromboembolic disorders and other vascular problems associated with the drug. The revised labeling now reads:

5.1 Thromboembolic Disorders and Other Vascular Problems
… The use of COCs increases the risk of venous thromboembolism. However, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use. Interim data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Interim data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC.

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