FDA Slaps Pfizer on Zoloft Ads After AHRP Files Complaint
Sat, 07 May 2005
On November 4, 2004, AHRP filed a complaint with the FDA about a two page Pfizer advertisement for its SSRI antidepressant, Zoloft. The ad appeared in The New York Times Magazine in October 2004, but Pfizer failed to include "ANY of the FDA required warnings about the increased suicide risk for patients taking Zoloft."
See AHRP letter of complaint: See: http://www.ahrp.org/infomail/04/11/01.php
The FDA has finally sent a letter admonishing Pfizer for failing to disclose the serious risks of worsening depression and increased suicidal behavior that its drug poses.
As we noted in our letter Pfizer’s advertisement in The Times violated fundamental FDA requirements by failing to include “specific disclosure requirements” and by “omit[ting]material facts” about risks – in this case, life-threatening risks.
The reproduced Zoloft Brief Summary (of the label) is grossly misleading about the suicide risk when it states: “Zoloft [is] working to correct the chemical imbalance,” stating: “Side effects may include dry mouth, insomnia, sexual side effects, diarrhea, nausea and sleepiness.”
Why did the FDA wait 6 months before writing a letter? Six months of continued direct to consumer advertising that appealed to consumers with false and misleading information while concealing serious health hazards may have led to preventable harm.
One cannot but wonder whether FDA’s tardiness is an example of the agency accommodation to a drug manufacturer’s sales goals?
Contact: Vera Hassner Sharav
Regulator slaps Pfizer on Zoloft ads
FDA orders No. 1 drugmaker to halt ads neglecting to warn of antidepressant’s fatal side effects.
May 6, 2005: 5:14 PM EDT
WASHINGTON (Reuters) – 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.
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