FDA OK's Prozac for Severe PMS

Friday, July 7th 2000, 12:00 am
By: News On 6

WASHINGTON (AP) — The popular anti-depressant Prozac just won a new use: to treat women suffering a severe form of premenstrual syndrome.

But if you use Prozac to treat this ``premenstrual dysphoric disorder,'' don't call it Prozac — the manufacturer has come up with a new name, Sarafem, to catch women's attention.

It's the same drug, known chemically as fluoxetine, the Food and Drug Administration stressed. But the Sarafem version of Prozac comes with a brochure explaining PMDD and in 7-day blister packs to help women track use of the pills.

Premenstrual complaints range from breast tenderness and bloating to anxiety and mood swings, occurring anytime between ovulation and menstruation each month. They affect 3 percent to 5 percent of women of childbearing age. But doctors say some who suffer very strong symptoms, including depression and irritability, actually have PMDD, a more severe premenstrual syndrome.

Doctors have long prescribed Prozac — and such competing antidepressants as Zoloft and Celexa — for these women, even though the FDA had never specifically approved them as PMDD treatments. It is legal for doctors to prescribe drugs for any purpose.

But Thursday's FDA approval of fluoxetine gives Eli Lilly and Company the bonus of being the first company allowed to advertise the therapy directly to PMDD sufferers.

One study concluded women who took the drug daily throughout the menstrual cycle saw a 36 percent improvement on a test measuring mood and other symptoms.

Side effects, including nausea, insomnia and headache, were similar to those all Prozac users face.

Lilly said the prescription-only Sarafem packs will be available in August, at Prozac's price.


On the Net:

Food and Drug Administration: http://www.fda.gov