Intended for healthcare professionals

News Roundup [abridged Versions Appear In The Paper Journal]

FDA panel urges “black box” warning for antidepressants

BMJ 2004; 329 doi: (Published 23 September 2004) Cite this as: BMJ 2004;329:702

APA at odds with FDA Advisory Panel

The American Psychiatric Association(APA) issued a News Release No.
04-47 on 13 September 2004. The release coincided with joint meetings of
the US Food and Drug Administration (FDA): The Psychopharmacological Drugs
Advisory Committee and the Pediatric Subcommittee of its Anti-Infective
Drugs Advisory Committee, Bethesda, Maryland, 13-14 September, 2004.

On 25 September, the BMJ published Jeanne Lenzer's overview article
entitled, “FDA panel urges ‘black box’ warning for antidepressants” (BMJ
2004; 329:702.) That article accurately described the events from those
two days. Lenzer’s comments included the important 15-8 vote taken by the
advisory panel to recommend to the FDA that enhanced side-effect warnings
should accompany all antidepressant marketing, including the use of
‘black box’ labeling.

Since the 13-14 September meetings, Dr. Robert Temple, associate
director for medical policy in the FDA’s Drug Evaluation Centre, has made
several statements indicating that the FDA is likely to agree with the
recommendation. On 17 September, Reuters reported that the FDA ‘generally
supports’ new warning labels for all antidepressants.

That position concurs with one endorsed by the Alliance for Human
Research Protection (AHRP.) Vera Sharav, founder of the AHRP, was
responsible for summoning an independent expert panel to Bethesda.
Testimony from that panel included remarks from Dr. David Healy, Director
of the North Wales Department of Psychological Medicine and Visiting
Professor, University of Toronto, whose research has been influential in
establishing heightened warnings for a class of antidepressants, the
selective serotonin reuptake inhibitors (SSRIs.)

At the time that the FDA advisory panels were meeting and Dr. Robert
Temple for the FDA and the AHRP-convened expert panel (including Dr.
Healy) were recommending stronger warnings for antidepressants, The
American Psychiatric Association issued its statement to “policymakers” in
their News release. The APA specifically recommended: “The continuation of
current FDA warnings with respect to SSRIs—warnings that are appropriate
and consistent with the scientific data.”

As a member of the expert panel and the APA, I am perplexed. Despite
the combined expert opinions arguing to increase warnings on
antidepressants, the APA’s position argues against it. Their
recommendation to maintain the current antidepressant warnings is
alarmingly contradictory to the FDA’s advisory panel and Dr. Temple’s
comments for the FDA, our expert panel and confusingly at odds with the
evidence. This begs the question: Why would the APA urge ‘policymakers’ to
continue current FDA warnings when the scientific data demonstrated the
evidence to be inconsistent with that position?

Stefan P. Kruszewski, M.D.

Member of AHRP Expert Panel, Bethesda, MD
September 13-14, 2004

Competing interests:
None declared

Competing interests: No competing interests

26 September 2004
Stefan P. Kruszewski
Harrisburg, PA 17112 USA