INDICES> U.S. FDA UPDATES WARNINGS FOR HEARTBURN DRUG

[Jody Dalmacion <jrvd1953@yahoo.com>]

INDICES> U.S. FDA UPDATES WARNINGS FOR HEARTBURN DRUG
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[response on an E-drug message; the E-drug moderator
referred this message to INDICES; WB]

May I just share with you my findings with cisapride
even prior to the FDA warning. I conducted a small
scale research in the use of active surveillance of
adverse drug reacion in our hospital last year. Our
hospital already has a spontaneous reporting system
for ADR.However, I  felt that more can be done because
we were collecting almost only dermatologic drug
reactions such as Steven Johnson, pruritus and rashes.
I was unhappy with this because I felt that we were
missing more serious or equally important ADRs not
necessarily dermatologic. By stroke of coincidence and
due to very limited fundings I chose the patients of
Gastrointestinal Clinic as study subjects. In just a 
month of chart review, I already noticed  a cluster of
patients (2) who underwent endoscopy with a diagnoses
of ulcer or gastritis but with concommitant diagnosis
of vertigo and /or syncopae. At the same time they
were taking an H1 blocker (ranitidine or cimetidine).
I interpreted this as the CNS side effect of cisapride
especially when combined with an H1 blocker. On
hindsight, I think that they were having syncopae from
a cardiac problem eg. arrhythmia. In fact, when I
presented this to our ADR subcommittee I showed my
bias towards a predictable CNS pathology instead of
suggesting further study. 
Based on this very limited experience, maybe I can add
to the FDA warning that patients taking cisapride and
having vertigo with or without H1 blocker  should be
examined for cardiac  problems aside from being  asked
to discontinue the drug.A lesson to me as a member of
the ADR subcommittee, always listen to your data and
its trend;dig deeper for alternative reasons.

Jody Vergeire-Dalmacion,MD,MS
Assoc Prof. Department of Pharmacology
UP College of Medicine
Philippines
Telefax No 0632 521 8251
E-Mail: jrvd1953@yahoo.com

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