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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:
FDA Consumer Magazine - Updates - September-October 2000




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