Prozac OKd for Treating Severe Premenstrual Stress
Prozac, the world’s best-known antidepressant, was approved Thursday by the Food and Drug Administration to treat women who suffer from severe mood swings, irritability and various other symptoms before their menstrual periods.
The drug’s maker, Eli Lilly and Co., plans to market it for that purpose under a new name--Sarafem--to send a message to women and their doctors that the condition, medically known as Premenstrual Dysphoric Disorder, or PMDD, is different from depression.
As many as 3 million American women may suffer from PMDD, which is estimated to affect from 3% to 5% of women during their reproductive years. Although up to 70% of women are bothered by at least some complaints--such as irritability or bloating-preceding menstrual periods, those with PMDD represent the extreme end of the spectrum.
To qualify for the diagnosis, a woman must have at least five symptoms on a monthly basis that are severe enough to interfere with her work or social functioning. The possible symptoms--a long list that includes mood disturbances, difficulty concentrating and physical problems, such as headaches or weight gain--generally occur in the latter half of a woman’s monthly cycle.
Fluoxetine (the chemical name for Prozac) was proven effective for women with PMDD in two studies in which subjects were treated either with the drug or with a placebo. Women in the studies filled out daily questionnaires describing how they felt. In one study, those who received 20 milligrams of fluoxetine daily reported a 36% reduction of their symptoms, on average, while women taking the placebo had a 7% reduction, said Thomas P. Laughren, the FDA’s team leader for psychiatric drug products.
“That effect is pretty big” compared with what is usually seen in such trials, he said.
One potential disadvantage for women who want to take fluoxetine for PMDD is that the drug is to be taken daily throughout the menstrual cycle, not just on days when the user doesn’t feel well. In the studies that documented fluoxetine’s effectiveness, women took it daily for up to six months. Researchers are trying to find out whether fluoxetine will help women with PMDD if they take it for only part of the month, said Laura Miller, a Lilly spokeswoman.
The studies also excluded women who were taking birth control pills, so the drug’s effectiveness for PMDD in such women isn’t known. Laughren said women who remain on fluoxetine for longer than six months should be periodically reevaluated by their doctors.
Fluoxetine belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs), which work by altering levels of serotonin, a chemical that transmits signals between nerve cells in the brain. The first studies suggesting that SSRIs helped women with PMDD appeared a few years ago, and Laughren said some doctors are already using Prozac and related drugs for that purpose.
Side effects of fluoxetine experienced by some women in the studies included nausea, fatigue, nervousness, dizziness and difficulty concentrating. Some women on SSRIs also report reduced sexual desire or satisfaction.
