Yeilding Concerns on Yaz

As seen in Consultant Connection January 2012 Issue
Submitted by: Heidi Trautwein PharmD, RPh, ICP Consultant Pharmacist

If you’ve watched television lately you’ve likely seen the legal commercials regarding Yasmin, Yaz, or Beyaz in relation to blood clots. In order to decipher the information about the above mentioned
medications you must fi rst understand what these drugs are. Beyaz, Yaz, Yasmin, and Safryl are all drospirenone-containing combination oral contraceptives (COC’s). Unlike many other COC’s the
drospirenone containing class has indications for use beyond just prevention of pregnancy. Beyaz and Safryl are additionally indicated to prevent pregnancy and raise folate levels, reducing the risk of
neural tube defects in those who might become pregnant while taking the medication. Beyaz and Yaz are indicated to prevent pregnancy and treat the emotional and physical symptoms of premenstrual
dysphoric disorder (PMDD), as well as treating moderate acne for women at least 14 yo and older. PMDD is an extreme form of premenstrual syndrome (PMS) caused by fluctuating hormones,
affecting 3-8% of women where they experience disabling irritability, depressed mood, anxiety, and mood swings. By defi nition, this mood disturbance results in marked social or occupational impairment, with its most prominent effects in interpersonal functioning.

All COC’s have an increased risk of blood clots, however recent concerns have been raised after European studies suggested an increased risk of blood clots linked to drospirenone containing
COC’s. The proposed theory is that some people respond differently to the drospirenone placing them possibly at higher risk than those on a non-drospirenone containing COC. On December 8, 2011 the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) held a meeting to discuss the available scientifi c evidence on the safety of drospirenone-containing COC’s. The majority of the committee found that the benefits of drospirenone-containing COC’s in the prevention of pregnancy outweigh the potential risks. The committee also voted that current labels for drospirenone-containing COC’s do not refl ect the risk benefi t profi le for these products and should be revised.

In response to the recent media hype over the drospirenone containing COC’s and the recent meetings held to review their safety, here are a few important safety advisories and monitoring suggestions you should know regarding Beyaz, Yaz, Yasmin, Safryl.
  • Thromboembolic and Other Vascular events: Drospirenonecontaining COC’s should be discontinued immediately if an arterial or deep venous thrombotic event occurs. The risk of venous thromboembolism (VTE) is highest during the fi rst year of use. All COC’s increase the risk of VTE. This risk is greater after a starting/restarting a COC after a 4 week or greater pill-free interval. COC use increases the risk of arterial thromboses (i.e. stroke, MI) especially in women who have pre-existing risk factors.
  • Hyperkalemia: Drospirenonecontaining COC’s have the potential for hyperkalemia in high-risk patients and are contraindicated in patients who have conditions predisposing them to hyperkalemia.  Serum Potassium levels should be drawn during the fi rst treatment cycle in patients who receive long-term treatment with other medications that increase serum Potassium such as ACE-I, ARB’s, Potassium sparing Diuretics, Heparin, Aldosterone Antagonists, NSAID’s, Digoxin.
  • Hypertension: Patient’s with uncontrolled hypertension or hypertension with vascular disease should not use COC’s. Monitor BP in women with well-controlled hypertension and if BP rises stop the COC.
  • Other adverse effects include: liver disease, gallbladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities, cervix carcinoma, cervical dysplasia, migraine, nausea/
  • vomiting, breast pain/tenderness, decreased libido, increased weight, PE, toxic skin eruption, uterine leiomyoma.
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