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ROCKVILLE, Md. — The Food and Drug Administration criticized GlaxoSmithKline’s Paxil CR marketing practices June 11, charging in a letter that a 60-second television commercial inappropriately suggests that Paxil CR can be used to treat too broad a range of conditions.
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GSK plans to work with the FDA to modify the ad campaign, according to published reports.
In an unrelated action earlier this month, the New York Attorney General’s office sued GSK for allegedly concealing information about the safety and efficacy of the anti-depressant drug Paxil to treat teens and children.
ANTIDEPRESSANT
A popular antidepressant, paroxetine (Paxil) may offer an alternative to hormone replacement therapy (HRT) for menopausal women suffering from hot flashes. Although HRT effectively controls hot flashes, recent research documenting its long-term dangers have made many women leery of using it.
In a study funded by GlaxoSmithKline, Paxil’s manufacturer, 165 menopausal women took Paxil (in either a low or moderate dose) or a placebo for 6 weeks and kept a daily diary of their hot flashes. All the women had at least two hot flashes per day at the beginning of the study, and none had depression or any other psychiatric illness.
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