Sarafem has been approved by the US Food and Drug Administration (FDA) for a relatively-new classification of mental disorder called PMDD, which is an extreme form of PMS suffered by 3% to 5% of women who experience PMS symptoms.
PMDDs classification as a mental disorder, rankles some feminists. In fact, some people, doctors among them, doubt the syndrome exists at all, though most concede the reality of PMS and its degree of severity in some patients. Other physicians have been prescribing Prozac off label to treat menstruation symptoms since 1995, when the drug was first tested for that use. Many doctors say they'll continue to prescribe Sarafem as they like, despite the FDAs and Eli Lillys contention that Sarafem should be limited to treatment for PMDD. Skeptics contend that despite Eli Lillys public posture, privately the company is hoping that Sarafem will tap into the PMS market and generate new business. A typical prescription is $90 per month, per woman and the drug must be taken daily or the symptoms return. The potential market is huge and, since the company is on the verge of losing their patent for Prozac, Serafem holds the promise of a new market of women, and an exclusive patent to serve that market.
PMDD is short for Premenstrual Dysphoric Disorder, its classification as a mental disorder. The most common most serious side effects are nausea and tiredness, according to Eli Lilly. The FDA says side effects are similar to Prozac, nausea and tiredness, but also nervousness, dizziness and difficulty concentrating.
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