The U.S. Food and Drug Administration has approved a new indication for fluoxetine, a selective serotonin reuptake inhibitor (SSRI), for the treatment of premenstrual dysphoric disorder (PMDD). Fluoxetine was previously sold only under the brand name Prozac. It is now marketed as Sarafem for treatment of PMDD.
PMDD causes depression, anxiety, irritability, anger and other symptoms in the two weeks before menses. The severity of symptoms of PMDD interfere with a patient's occupational and social functioning.
According to the January 22, 2001 issue of The Medical Letter, clinical trials of women with PMDD showed that fluoxetine taken in a dosage of 20 to 60 mg per day through six menstrual cycles improved mood symptoms in 53 percent of participants, compared with improvement in 28 percent of those who took placebo. Results of another trial suggest that taking 20 mg per day of fluoxetine only for the two weeks before menses might be as effective as taking it throughout the cycle.
The Medical Letter reports that the most common side effects associated with SSRIs are nausea, headache, nervousness, insomnia, rash, fatigue and sexual dysfunction, including decreased libido and anorgasmia. Prolonged use may lead to weight gain. Fluoxetine also inhibits cytochrome P450 enzymes 2D6 and 3A4 and interacts with many other drugs.
Sarafem and Prozac are both available in 10- and 20-mg capsules, but in different colors and different packaging. According to The Medical Letter, generic fluoxetine is expected to be available sometime in 2001.
COPYRIGHT 2001 American Academy of Family Physicians
COPYRIGHT 2001 Gale Group
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