Cymbalta Discontinuation Syndrome: FDA Review 2009
VERACARE
A Catalyst for Public Debate: Promoting Openness, Full Disclosure, and
Accountability
http://www.ahrp.org
FYI
Withdrawal from prescribed psychoactive drugs--drugs that affect the brain
and central is fraught with serious problem--as these drugs cause drug
dependency.
As a public service, AHRP has posted an FDA slide presentation /discussion
of a post-marketing review of Discontinuation / Withdrawal Syndrome reports
on the internet involving Eli Lilly's antidepressant, Cymbalta (duloxetine):
"Cymbalta (Duloxetine) Discontinuation Syndrome: Issues of Scope, Severity,
Duration & Management" http://www.ahrp.org/cms/content/view/620/56/
The slides--whose author(s) is unnamed--are dated June 9, 2009, the very day
of the Psychopharmacologic Drug Advisory Committee (PDAC) hearing.
It is unknown whether the PDAC panel was privy to this review--the findings
raise serious concerns:
1. "Cymbalta discontinuation syndrome is more severe and much more
widespread than acknowledged by Eli-Lilly."
Indeed an internet search found 1,440,000 hits for "Cymbalta" and
"withdrawal" compared to 562,000 hits for "Paxil" and "withdrawal"
and 538,000 hits for "Effexor" and "withdrawal."
When one takes into account the fact that Cymbalta is on the market since
2002, whereas Paxil is marketed since 1992 and Effexor since 1993, the
significance of the huge number of posts involving Cymbalta and withdrawal
problems is nothing short of staggering.
The FDA reviewer(s) is critical of Lilly's failure to acknowledge or address
the problem:
Slide 3:
1) Cymbalta discontinuation syndrome is more severe and much more widespread
than acknowledged by Eli-Lilly
2) Lilly sales representatives and marketing materials do not adequately
inform physicians about the likelihood and severity of discontinuation
syndrome
3) Lilly Direct to Consumer (DTC) advertizing is misleading related to the
probability, severity and complexity of Cymbalta discontinuation
4) Lilly has not developed and fielded a clinically proven protocol for
safely discontinuing Cymbalta
Slide 7:
Lilly sales representatives and marketing materials do not adequately inform
physicians about the likelihood
and severity of Cymbalta discontinuation syndrome
. Unaware physicians unable to discuss Cymbalta benefit-risk profile
(including discontinuation) with their patients
- Physicians can not make an accurate comparative assessment of
Cymbalta vs. alternatives
- Patients can not make an fully informed choice to take the drug
. Practical effects (common in anecdotal reports):
- Patient becomes totally distrustful of the physician who did not
advise/warn them in the first place
. Doctor /patient relationship is wrecked
. Patient in distress refuses to ingest Cymbalta under any pretext
. Tapering is taken off the table
- Patient fires the doctor or the doctor disengages from the patient
. Syndrome mood swings militate anger directed at the physician
. Physician may deny syndrome even exists
. Physician may jettison a newly "difficult" patient
- Physician seeks to avoid malpractice implications
- Patient becomes deeply suspicious of any psychotropic medication
. Underlying problem may go untreated
. THIS IS A PROCESS FLAW - THERE IS NO EXCUSE FOR IT
See all 18 slides at:
http://www.ahrp.org/cms/images/stories/articles/ucm172866_cymbaltadiscontinu
ation.pdf
or
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/D
rugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM172866.pdf
Contact: Vera Hassner Sharav
vera...@ahrp.org
212-595-8974
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