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Wyeth Effexor "broken heart" ads cited by FDA; agency is concerned about post-MI antidepressant promos.

Executive Summary

EFFEXOR AD LETTER REFLECTS FDA CONCERNS OVER POST-MI ANTIDEPRESSANT PROMOS, an issue that also figured in the warning letter FDA's Division of Drug Marketing, Advertising & Communication sent to Pfizer one year ago regarding Zoloft (sertraline). FDA sent a notice of violation letter to Wyeth-Ayerst July 25 concerning journal advertisements for the antidepressant Effexor (venlafaxine) that FDA maintained were "directed to depressed patient with concomitant heart disease."

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