FDA Warns Pfizer About Zoloft Magazine Ad

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http://www.lex18.com/Global/story.asp?S=3321371

FDA Warns Pfizer About Zoloft Magazine Ad

A magazine advertisement for the antidepressant Zoloft omitted important

information about the possibility of suicide, the U.S. 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 risks 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. " 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 Pfizer had agreed to change the Zoloft

label last July.

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.