Originally created 11/04/99

FDA advisers: Prozac could be PMS treatment



WASHINGTON -- The popular antidepressant Prozac also should be approved as a treatment for a severe form of premenstrual syndrome, advisers to the Food and Drug Administration decided Wednesday.

Premenstrual complaints, ranging from breast tenderness and bloating to anxiety and mood swings, affect 3 percent to 5 percent of women of childbearing age. But doctors say there is a more severe problem called premenstrual dysphoric disorder, or PMDD, which causes a smaller number of women such symptoms as poor concentration, depression and anger.

Doctors already routinely prescribe a number of antidepressants, such as Prozac, Zoloft and Celexa, to treat PMDD. The FDA has not specifically approved them as PMDD treatments, but it is legal for doctors to prescribe drugs for any purpose.

However, if the FDA were to approve an antidepressant as a PMDD treatment, then the manufacturer would get the added bonus of being able to advertise the drug directly to consumers.

On Wednesday, the FDA's scientific advisers voted unanimously that Prozac should be approved as a PMDD treatment. The FDA is not bound by the advice but typically follows it.

In one study, Prozac cut by two-thirds PMDD patients' scores on a mood test that measured their depression, tension and irritability. Side effects, including nausea, insomnia and headache, were similar to those all Prozac users face.