A Pfizer Inc. ad Zoloft left out an important warning about the risks of worsening depression or suicidal behavior in patients taking the drug, U.S. regulators said late Friday May 6, 2005. The failed to include a serious risk associated with the drug the FDA told Pfizer via letter.
The Food and Drug Administration told Pfizer to immediately stop using any similar promotional materials that omitted the warning. The original ad ran in The New York Times Magazine in October 2004.
<>The FDA asked Pfizer and other antidepressant makers more than one year ago to add warnings about the possibility that patients taking the drugs could experience worsening depression or suicidal thoughts or actions. Pfizer added the warning to the Zoloft label in July 2004 but failed to include the new information in the magazine ad, the FDA letter said.
Comment: Again, a huge pharmaceutical is told (in March of 2004) to add a warning. In a direct to consumer ad printed more than six months after the FDA's directive, the new information is not noted when an ad runs in a prominent periodical. Is a letter the proper "punishment?"
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