Drug OK'd to ease fall-winter 'blues'


WASHINGTON -- Americans suffering from severe, repeated cases of the winter blues now have a pill to provide help.

The Food and Drug Administration announced yesterday that it would allow sales of Wellbutrin XL, a prescription drug for major depression that has also been used to treat nicotine withdrawal, for adults 18 years and older suffering from the winter blues. The pill, made by GlaxoSmithKline, is the first approved for seasonal affective disorder, or SAD, as the blues are technically called.

The depression grips about 6 percent of adult Americans, many of them women, during the fall and winter, according to a study last year for the National Institutes of Health.

Seasonal affective disorder is typically mild, but it can also be quite severe, with symptoms similar to those experienced by sufferers of major depression, such as lack of sleep, loss of appetite and suicidal thinking. These episodes can last as long as six months and impair an individual's ability to socialize, have a relationship and work.

FDA approval permits GlaxoSmithKline to sell and market Wellbutrin XL to patients with serious histories of the winter blues. Doctors are free to prescribe drugs for uses not approved by the agency, and some had already been prescribing it or other antidepressants or mood stabilizers.

Dr. Douglas Jacobs, founder of the nonprofit Screening for Mental Health, said the FDA's approval would encourage more doctors to prescribe Wellbutrin XL pre-emptively in the fall, as well as raise awareness of the practice.

"It's very important because there are people who suffer on an annual basis," said Jacobs, who is an associate clinical professor of psychiatry at Harvard Medical School.

For most cases of the winter blues, which can cause lethargy and overeating, doctors recommend exposure to more sunlight or seeing a psychiatrist. The FDA permitted sales of Wellbutrin XL tablets for the most serious episodes.

"Seasonal affective disorder can significantly impair the quality of life of patients with this condition," Dr. Steven Galson, director of the FDA's drug review office, said in a statement. "Today's approval can help patients with this condition avoid the depressive symptoms and impaired functioning that typically affect them in the fall and winter."

Tests of 1,042 patients with a history of severe seasonal affective disorder found that use of Wellbutrin XL worked. At the end of treatment, 84 percent of patients on the drug were depression-free, compared with 72 percent on the placebo.

Side effects included risk of seizure, flatulence, constipation, weight loss, dry mouth, nausea, difficulty sleeping, dizziness or sore throat, according to GlaxoSmithKline.


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