E-drug: Double standard (cont'd)
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Dear E-Druggers,
Cisapride is a basic example of double standards concerning drug
safety and information between developed and developing countries
(more indications, less warnings and slow action).
Cisapride was withdrawn from the USA by the company's (semi)-
initiation; from Canada through action from Health Canada; but not in
Thailand. The Drug Study Group has sent a letter (12 June) to the
Chairman of the Drug Board requesting to withdraw this drug. Instead,
the company proposed to continue marketing it with the same 5
indications, though suggested some tighter actions, but without a
warning on cimetidine interaction. It was argued that there were no
concrete data on adverse reactions from the interaction between these
two drugs. The ADR subcommittee thus concluded that Thailand
should not withdraw cisapride yet because EU did not have any action
about this drug. This conclusion came as the basis that if the mother
drug company has withdrawn their product from the country of origin,
the ADR subcommittee will issues such action.
The 5 approved indications in Thailand for cisapride are, in summary,
gastroparesis, symptoms of X-ray or endoscopy negative upper
digestive discomfort, GERD, intestinal pseudo-obstruction, restoration
of colonic propulsive motility. That in USA is for GERD only. Cisapride
is classified as Pharmacy drug, with 37 registration numbers (both
original and generic). During the debate this drug is not suspended so
the consumer can purchase it without a prescription and even without
pharmacist guidance.
Niyada Kiatying-Angsulee
Drug Study Group
11/156 Soi Kawna 2 Charansanitwong 13
Bangkok 10160 Thailand
Tel +662-4102382 Fax: +662-4106271
e mail: kniyada@hotmail.com
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