Healthy Skepticism Library item: 1508

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Reuters .
Regulator slaps Pfizer on Zoloft ads: FDA orders No. 1 drugmaker to halt ads neglecting to warn of antidepressant's fatal side effects.
CNN Money 2005 May 6;

Full text:

A Pfizer Inc. advertisement for antidepressant Zoloft left out an important warning about the risks of worsening depression or suicidal behavior in patients taking the drug, regulators said on Friday.

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 ad raised public health concerns “because it fails to include a serious risk associated with the drug,” the FDA said in a letter to the company.

The FDA asked Pfizer and other antidepressant makers in March 2004 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.

A Pfizer spokeswoman did not immediately return a call seeking comment.

Shares of Pfizer (Research) edged lower in after-hours trading Friday after falling 0.9 percent in regular New York Stock Exchange trading.