E-DRUG: Is buclizine an appetite stimulant? (2)
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The major question here is: what does the Approved Product Information say
about the indications for buclizine?
[the Approved Product Information is part of the decision by the Drug
Regulatory Authority when considering the efficacy, safety and quality of
any drug product]
If the Approved Product Information does not give appetite stimulation as an
indication, then the company is breaking the law (among other things!) in
these advertisements.
Dr Krisantha Weerasuriya
Essential Drugs and Medicines Policy (EDM)
WHO South-East Asia Regional Office (SEARO),
World Health House, New Delhi, 110 002, India
Phone +91 11 2337 0804 ext 26314
Mobile +91 98104 16366
Fax +91 11 2337 8510
Email: weerasuriyak@whosea.org
[Does any E-drugger from India have access to the buclizine "approved
product information" as decided by the Indian Drug Regulatory Authority? If
so, there are 3 possibilities:
1. If such a text exists, and it contains "appetite stimulant" as an
approved indication for children, then the company is legally covered and
may claim the indication in adverts. The question of cause remains: is it
ethically and morally justified to promote appetite stimulants for children
in a country where millions of children have no food?
2. If the product information does NOT list the indication, then the
advertisements should be illegal, and the DRA should write to the company
removing the indication.
3. If there is NO Approved Product Information, then the company should
defend the indication with evidence-based science. It would be recommended
if the DRA reviewed the product and take a decision whether the current
practice is evidence based.
Do E-druggers think that the published paper in an Indian Journal
(Buclizine � Rajadhyaksha et al, Indian medical gazette, nov. 1998, vol
CXXXII no. 11, 327-330?) showing appetite stimulant and weight gain effects
of a few 30 year old clinical trials of Buclizine is sufficient evidence??
The debate is open!
Wilbert Bannenberg, E-drug moderator
Email: wjb@planet.nl
]
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