E-drug: New drug info resource (cont'd)
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Dear E-Druggers,
After comparing Medscape's patient information for cisapride
(www.medscape.com/druginfo) to the FDA approved information for the drug on
Janssen's home page (www.janssen.com/products/pi_files/propulsMG.pdf), I
disagree with Wendy Grosvenor's description of this information as "patient
friendly." The U.S. Food and Drug Administration estimated that 85 percent
of the cases of serious events they received occurred in patients with known
contraindications to cisapride. The Medscape information does not
incorporate many of the warnings that have been included in recent labeling
changes for the drug in the U.S.
If cisapride is continuing to be prescribed to patients with known
contraindications, patients should be given information they can use to
prevent injury. The Medscape information for cisapride must be regarded as
"patient unfriendly" unless extensively rewritten.
The point that was apparently being made in an earlier posting was that
based on quality of the content of the Medscape cisapride information that
pharmacists should exercise the same amount of caution in dispensing this
information (cisapride and other Medscape patient information leaflets) as
they do in dispensing drugs.
The only labeled use for cisapride in the U.S. is the symptomatic treatment
of nocturnal heartburn due to gastroesophageal reflux disease (GERD) in
adults. The recommended dose is 10 mg four times a day, up to 20 mg four
times a day.
In Canada, the drug is also labeled for use in gastroparesis and
pseudo-obstruction. The regulatory basis for these uses is unknown as our
approval process, like most other countries, lacks transparency. The
maximum recommended dose in Canada for any labeled condition is 40
milligrams per day versus 80 milligrams in the U.S. I do not know the
approved uses or the recommended doses for cisapride in other countries.
Spontaneous reports of adverse events are always difficult to interpret.
The moderator's comment that no problems have been seen in Japan is not
comforting.
Through September 16, 1999, the Canadian Adverse Drug Reaction Monitoring
Program had received 12 reports of deaths associated with the use of
cisapride. Five of these were related to heart rate and rhythm disorders (2
of these involved drug interactions), and 7 had various contributory
factors: confounding medical conditions (3), overdose (1), neonatal death
(1)(Canadian Adverse Drug Reaction Newsletter, Volume 10, Number 1, January
2000). Given that the drug has been marketed for approximately the same
period of time in Canada and the U.S. and that Canada is about one-tenth the
population of the U.S., the reporting rates for fatalities appear similar
despite the lower recommended dose for cisapride in Canada.
Cisapride will be off USA market on July 14,00. Several Canadian hospitals
have recently removed cisapride from their formularies. My former hospital
in Saudi Arabia has restriction on cisapride use to gastroenterologists.
Sana R. Sukkari, B.Sc.Pharm., M.Phil.
e-mail: ssukkari@jbmh.com
[Please could you provide your affiliation and physical address with
each contribution, BS, co-moderator]
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