FDA Updates Safety Label for Yaz, Yasmin, Beyaz and Safyral

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FDA Updates Safety Label for Yaz, Yasmin, Beyaz and SafyralOverview

When Yaz first came onto the market, it seemed like an easy, appealing choice for those seeking superior birth control; women were led to believe that this miraculous little pill would not only prevent pregnancy, but clear up any acne and help with pre-menstrual syndrome (PMS). But as many users have learned, questioning whether something is “too good to be true” seems a wise cliché indeed. Not only did Bayer mislead the women about the benefits of Yaz, but experts now strongly suspect that the contraceptive can lead to serious, even deadly, side effects such as blood clots. After the reviewing the data concerning this issue, the U.S. Food and Drug Administration (FDA) has decided to update the safety label on Yaz, Yasmin and other drospirenone-containing birth control pills.

  • The FDA is updating labels for Yaz, Yasmin, Beyaz and Safyral due to an increased risk of blood clots which can lead to heart attack, stroke and death
  • In the past, Bayer has produced misleading advertisements about Yaz and was forced to correct them; Yaz is not approved to treat all stages of acne, nor does it treat PMS. It is only approved to treat premenstrual dysphoric disorder (PMDD), which is more severe and less common.

Product: Yaz, Yasmin, Beyaz, Safyral

Manufacturer: Bayer Healthcare

Injuries & Side Effects

  • Blood Clots
  • Pulmonary Embolism (PE)
  • Deep Vein Thrombosis (DVT)
  • Gallbladder Damage
  • Heart Attacks
  • Stroke

Updated Safety Labels

After reviewing observational studies, the FDA “has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.” The new labels will include the results of conflicted findings, citing one study that found a three-fold increased risk of blood clots in women who took oral contraceptives containing drospirenone. The FDA has provided the following chart of birth control pills that have drospirenone:

FDA Approved Oral Contraceptives Containing Drospirenone

 Brand name Generic name
 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 0.03 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
 Yasmin Drospirenone 3 mg and ethinyl estradiol 0.03 mg
 Yaz Drospirenone 3 mg and ethinyl estradiol 0.02 mg
 Zarah Drospirenone 3 mg and ethinyl estradiol 0.03 mg

(Source- FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone)

Background

Beyaz, Safyral, Yaz and its predecessor Yasmin all use a synthetic chemical known as drospirenone, which is meant to mimic the progesterone naturally found in women. Users have not been blind to the potentially fatal side effects of these drospirenone-containing medications, nor have certain experts. Last December, former FDA commissioner David Kessler publicly stating that “Bayer violated its duties under FDA regulations and state law by selectively presenting data as to thromboembolic events, which did not adequately inform FDA, doctors or consumers of the thromboembolic risks, from pre-marketing to the present. His claim certainly seems accurate, as one FDA-funded study revealed a 75 percent increased risk of blood clots in women taking drospirenone-based birth control. By early February, the company faced over 11,000 product liability claims; Bayer attempted to move litigation forward a few weeks later and agreed to settle 70 lawsuits.