Food and Drug Administration
U.S. Department of Health and Human Services
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T00-31 Print Media: 301-827-6242
July 6, 2000
Consumer Inquiries: 888-INFO-FDA
FDA has approved fluoxetine (Sarafem) as the first drug treatment for Premenstrual Dysphoric Disorder(PMDD), a disorder that causes mood changes and physical symptoms such as bloating and breast tenderness in women. Fluoxetine was approved as Prozac in December l987 for treating depression, and has also been approved for treating obsessive compulsive disorder and bulimia. The following may be used to respond to questions.
On November 3, 1999, FDA's Psychopharmacologic Advisory Committee unanimously recommended approval for fluoxetine to treat women with PMDD. The committee concluded that fluoxetine was effective for the condition and that PMDD has well defined, accepted diagnostic criteria. The committee also advised that the drug should be used only to treat women whose symptoms are severe enough to interfere with functioning at work or school, or with social activities and relationships.
According to the American Psychiatric Association Diagnostic and Statistical Manual (DSM-IV), a diagnosis of PMDD requires that patients experience at least five of the symptoms that characterize PMDD. PMDD has both affective (mood) and physical symptoms, and is characterized by depressed mood, anxiety, tension, affective lability (a tendency to alternate between cheerful and somber moods), and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite, headache, joint and muscle pain. The mood symptoms often cause disturbances in social relationships. Physical symptoms include weight gain, bloating, and breast tenderness. To support a diagnosis of PMDD, the symptoms must occur regularly in the luteal phase of a woman's cycle, and disappear after onset of menstruation. (The luteal phase corresponds to the period between ovulation and onset of menstruation.)
Fluoxetine's effectiveness for the treatment of PMDD was established in two double-blind placebo-controlled trials. In the first study, 320 patients were given fluoxetine continuously throughout the menstrual cycle. This study showed that the drug was significantly more effective than placebo by measurements of changes in mood and physical symptoms of PMDD. In a second study, 19 patients were treated with fluoxetine and placebo continuously throughout the menstrual cycle for a period of three months each. In this study, fluoxetine was significantly more effective than placebo on a scale measuring changes in mood, physical and social impairment symptoms.
Sarafem will be marketed by Eli Lilly, of Indianapolis, Ind., with a patient information brochure and physician labeling specific for the drug's use. The drug was not studied in women who were taking oral contraceptives. Common side effects were similar to those experienced by other fluoxetine users and included nausea, tiredness, nervousness, dizziness and difficulty concentrating.
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