PMS Resource
Center
New
Treatment Approved for Severe Premenstrual Symptoms
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.
A 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).
"Women 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 the condition.
Available 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.
In
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.
article
syndicated from U.S.
Food and Drug Administration:
http://www.fda.gov/fdac/departs/2000/500_upd.html
FDA Consumer Magazine - Updates - September-October
2000
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