The US Food and Drug Administration has stamped down on a Pfizer advert promoting the use of its top-selling antidepressant Zoloft (sertraline), saying it failed to mention the risk of worsening depression or suicidal behaviour amongst patients.
Last March, the US drug regulator ruled that all antidepressants should include a warning of suicidal behaviour on their labeling – and that patients should be observed closely, especially at the start of therapy and during dose changes [[23/03/04a]]. Pfizer saw approval of its new labeling in the July, but failed to include the information in its ad – published in The New York Times Magazine.
The FDA has ordered a halt on all such promotional materials for Zoloft, and has asked Pfizer to explain how it intends to do this by the end of the month.
