FDA Approves Prozac for Treating Severe Form of PMS

From the WebMD Archives

July 6, 2000 (Washington) -- The world's leading antidepressant has a new use and a new name. The FDA on Thursday approved Sarafem for the treatment of premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome. Sarafem is the equivalent of Prozac, which now is used to treat depression, obsessive-compulsive disorder, and bulimia.

Prozac is now also the first and only FDA-approved treatment for PMDD. But to help distinguish PMDD from mood disorders, Prozac will be sold under the trade name Sarafem for this use, says Laura Miller, a spokeswoman for Eli Lilly, which makes the drug.

"It lets women know that there is a treatment for this disorder while avoiding confusion about the differences between depression and PMDD," she tells WebMD. Research shows that having a treatment with its own identity available can help women and physicians distinguish symptoms of PMDD from depression, ultimately helping more PMDD sufferers get the appropriate diagnosis, treatment, and follow-up care, Miller explains.

PMDD is characterized by depression, anxiety, tension, and severe mood changes, as well as physical symptoms such as weight gain, bloating, and tenderness. To support a diagnosis of PMDD, these symptoms must occur regularly during the period between ovulation and onset of menstruation. The symptoms also must be severe enough to interfere with work, school, or social activities, and personal relationships.

The FDA approval was based in part upon the recommendation of an FDA expert advisory committee, which in November 1999 concluded that PMDD is a diagnosable condition and that the antidepressant is an effective treatment, FDA spokeswoman Susan Cruzan tells WebMD.

The committee recommendation was based upon two clinical trials showing that the drug was significantly more effective than a placebo in helping improve patients' mood, physical symptoms, and ability to function socially. In those studies, women were treated throughout their menstrual cycles for a period of three months. Although researchers do not know why the drug helped ease the symptoms, they speculate that it may interact with the brain chemical serotonin, which is thought to trigger symptoms of PMDD when it is off balance.

Over-the-counter drugs are available to treat some symptoms of premenstrual syndrome (PMS), Cruzan says. But PMS is not well-defined, unlike PMDD, which affects an estimated 3-5% of menstruating women in the U.S., she tells WebMD.

Educational materials will be included in packages of Sarafem to help women with PMDD understand their diagnosis and treatment, Miller adds. These packages should be available in pharmacies by August, she tells WebMD.

The most commonly observed side effects of Sarafem in the U.S. studies included headaches, nausea, drowsiness, nervousness, dizziness, and difficulty concentrating.