The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) reviewed a print advertisement for Zoloft (sertraline HCl) tablets published in the New York Times magazine last October.
The regulator found the direct-to-consumer ad to be false or misleading as it omits important information relating to the risk of suicidality in patients taking the medication. According to the FDA’s letter, the main page of the advert does not communicate any information relating to the risk of clinical worsening and suicidality and the ad’s summary page is from an outdated product information sheet.
The DDMAC has requested that Pfizer immediately stop distributing such promotional materials for Zoloft.
According to Pfizer, Zoloft is the number one doctor-prescribed brand of its kind, having treated more types of depression and anxiety than any rival brand for over a decade.