The FDA has approved Berlex's new oral contraceptive (OC), YAZ, a monophasic pill that combines 3 mg drospirenone with 20 mcg ethinyl estradiol. The 24-day, active hormone pill regimen of YAZ results in less hormonal fluctuation than traditional OCs. YAZ is a low-dose version of the company's OC Yasmine.

According to Berlex, a large clinical trial of YAZ established the safety of the product and demonstrated 99% contraceptive efficacy. The trial also showed that YAZ provides predictable monthly withdrawal bleeding with breakthrough bleeding rates comparable to other low-dose OCs. Preclinical studies indicate that drospirenone also provides an antiandrogenic effect.

YAZ was well tolerated by most women in the clinical trial.The most common side effects were similar to other OCs and included upper respiratory infection, headache, breast pain, vaginal moniliasis, leukorrhea, diarrhea, and nausea.

YAZ should not be used in patients with conditions that predispose them to hyperkalemia. Women getting daily, long-term treatment for chronic conditions or medications that may increase serum potassium should have their serum potassium levels checked during the first treatment cycle.