New Oral Contraceptive Yasmin Gets FDA Approval

A new low dose oral contraceptive called Yasmin (Berlex Laboratories) received marketing approval from the US Food and Drug Administration (FDA) in May 2001. This pill contains 30 mcg of ethinyl estradiol ("low dose") along with a unique progestin that also helps reduce water retention. Yasmin contains 3 mg of drospirenone, a novel progestin that, as an analogue of spironolactone, affects the regulation of water levels and electrolyte balance in the body. According to Dr. Candace Brown, Professor of Obstetrics and Gynecology at the University of Tennessee, the new drug may be ideal for patients who want an oral contraceptive and who also experience premenstrual symptoms such as bloating and irritability. Yasmin is contraindicated in patients with kidney, liver or adrenal disease because the progestin may increase potassium levels in some patients. Yasmin appears to offer better weight control by reducing water retention. Yasmin also may not be appropriate in the presence of several other drugs, including certain over-the-counter pain relievers, potassium sparing diuretics, potassium supplements, ACE inhibitors, and angiotensin-II receptor antagonists. According to the manufacturer, Berlex, Yasmin was tested in 2629 women over more than 33,160 menstrual cycles. Only one pregnancy occurred in 326 patients taking Yasmin during 3201 cycles. The most common side effects associated with the drug were emotional liability, headache, nausea, dysmenorrhea, intermenstrual bleeding and depression. Yasmin has also been associated with improved acne and seborrhea as well as an improved sense of well-being.

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Created: 5/24/2001  -  Donnica Moore, M.D.
Reviewed: 8/20/2002  -  Donnica Moore, M.D.