Treatment Approved for Severe Premenstrual
article syndicated from FDA
The popular antidepressant Prozac now has another
use and another name. FDA approved fluoxetine (Sarafem)
in July for the treatment of Premenstrual Dysphoric
Disorder (PMDD). Fluoxetine was approved in 1987 under
the name of Prozac for treating depression, and has
also been approved for treating obsessive-compulsive
disorder and bulimia. The manufacturer, Eli Lilly,
of Indianapolis, Ind., renamed the drug Sarafem for
its new use to treat PMDD.
woman is diagnosed with PMDD when she experiences at
least five of eleven symptoms regularly between ovulation
and menstruation (about one to two weeks before her
period). One of the five symptoms must be: markedly
depressed mood, noticeable anxiety or tension, sudden
sadness or tearfulness, or persistent anger or irritability.
The other symptoms may include: decreased interest
in activities, difficulty concentrating, lack of energy,
change in appetite, sleeping too much or too little,
a sense of being overwhelmed, or physical symptoms
(headache, joint and muscle pain, weight gain, bloating,
or breast tenderness).
who have PMDD are likely to miss work or school, and
have increased interpersonal and domestic problems," says
Thomas Laughren, M.D., a medical officer in FDA's Center
for Drug Evaluation and Research. The symptoms of PMDD
are more severe than those of premenstrual syndrome
(PMS), according to Laughren. About 3 to 5 percent
of women of child-bearing age are estimated to have
by prescription only, Sarafem comes in packages of
28 pills and is priced the same as Prozac, according
to the manufacturer. The drug is to be taken daily--not
just on the days the patient isn't feeling well.
studies, Sarafem was found to be significantly more
effective than a placebo. Its effectiveness in women
taking birth control pills is not yet known, since
this group was excluded from the studies. Side effects
of the drug include nausea, tiredness, nervousness,
dizziness, and difficulty concentrating.
syndicated from U.S.
Food and Drug Administration:
FDA Consumer Magazine - Updates - September-October