US FDA says Pfizer Zoloft ad left out key warning

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US FDA says Pfizer Zoloft ad left out key warning

06 May 2005 20:53:07 GMT

Source: Reuters

(Adds details, FDA comments)

 

WASHINGTON, May 6 (Reuters) - A Pfizer Inc. <PFE.N> advertisement for

antidepressant Zoloft left out an important warning about the risks of

worsening depression or suicidal behavior in patients taking the drug,

U.S. 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.