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From the Food and Drug Administration
September 13, 2000

New Indication for Fluoxetine

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Copyright 2000 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2000American Medical Association

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JAMA. 2000;284(10):1234. doi:10.1001/jama.284.10.1234-JFD00007-2-1

The FDA has approved fluoxetine hydrochloride (Sarafem, Eli Lilly & Co, Indianapolis, Ind) as the first treatment for premenstrual dysphoric disorder. The mechanism of action of fluoxetine in this disorder is unknown, but it is presumed to be linked to its inhibition of nerve cell uptake of serotonin in the central nervous system.

Patients with premenstrual dysphoric disorder experience at least five essential symptoms that include markedly depressed mood, anxiety or tension, affective lability, persistent anger or irritability, decreased interest in activities, difficulty concentrating, and lack of energy. Physical symptoms include breast tenderness, headache, joint and muscle pain, bloating, and weight gain. In diagnosis, care should be taken to rule out other cyclical mood disorders such as mania and hypomania that may be exacerbated by antidepressant treatment.

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