FDA Warns Pfizer About Zoloft Magazine AdMay 9, 2005 | www.healthcentral.com A magazine advertisement for the antidepressant Zoloft omitted important information about the possibility of suicide, The Food and Drug Administration said in a May 6 letter to the drug's manufacturer, Pfizer Inc.
The letter, along with a warning to health care professionals about possible suicide risk with Zoloft, was posted on the FDA's Web site Friday. The Wall Street Journal reports that the ad the government agency mentioned was one that ran in the New York Times Sunday Magazine Oct. 24, 2004. The FDA letter reminded Pfizer it had alerted the pharmaceutical company in May 2004 that the information had to be included the labeling material on all print advertising.
"This ad is concerning from a public health perspective because it fails to include a serious risk associated with the drug," the FDA Consumer Promotion Analyst Kay A. Chitale wrote. She told Pfizer to immediately stop using that particular ad or similar ones. "Specifically, the main page of the ad fails to communicate any information pertaining to the risk of clinical worsening and suicidality in patients who are on Zoloft therapy," Chitale concluded.
The Wall Street Journal said that the Pfizer had agreed to change the Zoloft label last July. The pharmaceutical company didn't return a phone call from the newspaper asking for comment, the Journal said.
Whether deliberately or by coincidence, the FDA issued the alert about Zoloft and the risk of pediatric suicide (www.fda.gov ) to the public and health officials on May 5.