Sarajem will be sold at the same price as Prosac
"FDA OK's Prozac for Severe PMS
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."
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On the Net:
Food and Drug Administration: fda.gov
InSook Prasad |
