The Food and Drug Administration last week approved an old medication for a new use. The drug: the antidepressant Zoloft. The new purpose: something called premenstrual dysphoric disorder.
I know about PMS--premenstrual syndrome--but PMDD was a new one on me, so I made a few calls. "PMDD is actually severe PMS," explained Dr. Kimberly Yonkers, an associate professor of psychiatry at Yale and the lead researcher of the FDA's clinical trials. Why not just call it PMS? "Well, it's more complicated than that," she told me. "It involves emotional symptoms."
PMS also has an emotional element--as most women, and many men, can testify--but in PMDD the emotional symptoms are much more serious. (Dysphoria is sort of the opposite of euphoria.) The American Psychiatric Association's official manual describes PMDD as having at least five of the following symptoms: sadness, anxiety, mood swings, persistent irritability, withdrawal, difficulty concentrating, fatigue, marked changes in appetite and sleep patterns, a feeling of being overwhelmed and such physical symptoms as headache, joint and muscle pain, weight gain and bloating.
"Women with PMDD have significant impairment," says Yonkers. "They snap at their children and their spouse. They can't do everything they need to do at home. They pass on social engagements and sometimes miss work."
If PMDD sounds a lot like major depression, that's because the symptoms are very similar. So it's not surprising that standard antidepressants can help. In July 2000, the agency approved the antidepressant fluoxetine (Sarafem) to treat PMDD. Now sertraline (Zoloft) has also been given the nod largely on the strength of Yonkers' study of 200 women with PMDD. That research, first published in the Journal of the American Medical Association, showed Zoloft to be significantly more effective than a sugar pill.
It could be that other therapies--hormones, say, or even psychotherapy--work just as well as Zoloft and Sarafem. But as Yonkers points out, they have not been as carefully studied as the drugs have. And that's good enough for her. "If a patient came into my office with PMDD," she says, "I would likely prescribe medications almost immediately as a first-line therapy."
There are risks with this approach. Like any medication, Zoloft can trigger side effects, including upset stomach, fatigue and agitation. Interestingly, those side effects could very easily be confused with the symptoms of PMS.
Still curious why severe PMS came to be called PMDD, I put the question to Yonkers one more time. "Patients find it helpful to have a name for something," she replied. "Plus, it legitimizes a very real problem."
I know better than to argue with that.
--With reporting by Rhonda Rowland/Atlanta
Dr. Gupta is a neurosurgeon and CNN medical correspondent