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Drug targets premenstrual symptoms

By WES ALLISON

© St. Petersburg Times, published May 1, 2001


Brand name: Sarafem
Generic name: fluoxetine hydrochloride
Purpose: Treat premenstrual dysphoric disorder
Manufacturer: Eli Lilly & Co.
Availability: By prescription only, in pill form
Cost: About $98 for a month's supply.
How it works: Sarafem, which has the same active ingredient as the anti-depressant Prozac, increases levels of seratonin in the brain, a chemical that improves the way neural cells communicate with each other.
It is the first and only drug specifically approved by the U.S. Food and Drug Administration for PMDD.
Side effects: Tiredness, upset stomach, nervousness, difficulty concentrating, changes in sexual desire or satisfaction
The Pitch: "Think it's PMS? Think again. It could be PMDD. . . . PMDD, premenstrual dysphoric disorder, is a distinct medical condition that is characterized by intense mood and physical symptoms right before your period."
A major television campaign ended recently, and ads are running now in magazines geared toward women.
What it says: The TV ads featured women who acted ornery before they took Sarafem, then acted happy afterward. Some print ads come with a self test that asks whether you suffer "irritability, tension, sensitivity, sadness, bloating, tiredness, breast tenderness, feeling overwhelmed," and whether those symptoms affect your "work, school, social activities, relationships."
"If you've checked some of the boxes," the test advises, "discuss your answers with your doctor to determine if you have PMDD."
How it scores: Lilly has repackaged its blockbuster anti-depressant, Prozac, to offer it as a cure for something most women likely have never heard of. Lilly has incentive to find new uses for the chemical. Its patent on Prozac expires in August and the price is expected to fall. But Sarafem, a new application for the drug, is protected for the next six years.
While PMDD is a distinct medical condition, it is not widely addressed in the medical literature and affects fewer than 5 percent of women, those who suffer premenstrual symptoms so severe that they impair daily activities. Yet, under the criteria established by the advertisement's self test, many women could qualify as possibly having it.
"Most women experience these effects to some degree, and I think a lot of women are going to want to try it," said Dr. Madelyn Butler, an obstetrician-gynecologist at the Women's Group in Tampa.
But, she stressed, most don't need it. Cutting caffeine, eating healthful foods and exercising and resting can help most people.
Butler said some patients who suffer from severe symptoms of premenstrual syndrome have benefited from Sarafem. Others have asked about it, but their interest wanes when they learn has side effects and that they must take the drug regularly, she said.

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