E-DRUG: Cyproheptadine and anabolic steroid
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Dear E-drug members,
Syrup preparation of cyproheptadine and vitamine or anabolic steroids recieved
attention and restricted regulatory actions were issued in many countries long
time ago due to irrational marketing promotion for using as appetite stimulant in
malnourished children.
In Thailand, however, this combination is still approved as appetite stimulant.
Labeling is contradictory since it mentions not allowed for use in children but dosing
allows for children over one year old and prohibited for using over 3 months in
children.
No action was taken by Thai FDA until recently that two cases of
adverse events from this product were reported. Campaigned is now being
done by NGOs. Nonetheless FDA still showed reluctance to act (withdraw the
product), asking manufacturer to voluntary return the marketing authorization
certificate.
So I would like to ask for help from you all regarding these questions.
1. Whether this product is still available in your country, and with what indication?
2. Any regulatory action in your country so far due to irrational combination,
safety, and etc.?
3. Which country has never registered this product?
4. Whether methandienone is benefit for ageing, pain relief, osteoporosis, and
diabetes mellitus (claim by Thai FDA)
5. Suggestion how to convince our Thai FDA to take action
6. Any more comments on this combination?
There are so many irrational combination drugs still available in developing
countries, especially in Thailand with no attempt to re-evaluate.
Your help in this matter is greatly appreciated.
Bets wishes,
Niyada
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Niyada Kiatying-Angsulee, Ph.D.
Social Pharmacy Research Unit (SPR)
Faculty of Pharmaceutical Sciences
Chulalongkorn University
Phayathai Rd., Bangkok 10330, Thailand
T/F. +662-2188443
email: niyada.k@chula.ac.th