- Dr. Tracy attended both the 1991 FDA hearing on antidepressants
and today's hearing on antidepressants.
-
- Strengthened warnings about the risk of suicide ideation
and attempts with antidepressant medications in children should be communicated
to physicians and consumers as soon as possible, a joint FDA advisory committee
told the agency Feb. 2.
-
- The warnings should be issued about the possible risk
of suicidal behavior with antidepressants at the same time as FDA proceeds
with a re-analysis of pediatric data from manufacturers to verify whether
a signal seen with the drugs has a more definitive association, members
of the joint committee said.
-
- Warnings are needed in the interim to "elevate the
level of concern and attention that practitioners use in prescribing"
antidepressant medications, Psychopharmacologic Drugs Advisory Committee
Chair Matthew Rudorfer, MD, National Institute of Mental Health, explained.
The Psychopharm committee met with the Pediatric Subcommittee of the Anti-Infective
Drugs Advisory Committee.
-
- "We want to put a speed bump in the road,"
Rudorfer said, so that the psychiatrists and non-psychiatric physicians
who are prescribing antidepressants "take the medications more seriously."
-
- FDA's preliminary review of summary data provided by
antidepressant sponsors revealed a signal of increased risk of suicidality
for paroxetine (GlaxoSmithKline's Paxil), sertraline (Pfizer's Zoloft),
venlafaxine (Wyeth's Effexor), and citalopram (Forest's Celexa).
-
- Lilly's Prozac (fluoxetine) has not been associated with
a similar signal and is the only selective serotonin inhibitor to be indicated
for pediatric major depressive disorder. Pediatric studies for the other
SSRIs have been negative or inconclusive concerning efficacy for depression
in children.
- FDA wants to further analyze the safety data after events
reported from the manufacturers have been reclassified for suicidal behavior
by an outside expert panel assembled by Columbia University.
-
- Members of the FDA's advisory committee said that the
panel should not only look at suicidal behavior but also evidence of "activation"
in patients on the drugs. Indications of activation could include increased
agitation, aggression, akathisia (uncontrollable limb and body movements),
confusion, and violence toward others.
-
- The committee heard from 65 speakers during the meeting's
public hearing, many of whom were parents of children who had committed
or attempted suicide or homicide after a short time on antidepressants.
Many described severe behavioral changes in their children.
-
- FDA expects to re-analyze the data by this summer and
hold another advisory committee to discuss more definitive regulatory actions
for the antidepressant class.
-
- To watch a live or archived webcast of this meeting,
click the button below. To arrange for live videoconferencing or to order
videotapes & CDs, email <mailto:webcasthelp@elsevier.com>webcasthelp@elsevier.com
or call 800-627-8171.
-
- http://fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Committees/Anti-In
fective+Drugs/020204_Suicide/020204_SuicideR.htm
-
-
-
- Ann Blake Tracy, PhD
- Executive Director, International Coalition For Drug
Awareness
- Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare
- And an audio tape on safe withdrawal: "Help! I Can't
Get
- Off My Antidepressant!" (800-280-0730)
-
- Office: 801-282-5282
- E-mail: atracyphd1@aol.com
- Website: <>www.drugawareness.org
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