Drug controller bans use of Buclizine in children to induce hunger
Government of India has prohibited the use of anti-allergy drug Buclizine as an appetite stimulant. In an order issued earlier this month, the Central Drugs and Standards Control Organisation (CDSCO) has said that the drug which is also approved for use for vertigo, should not be used to increase appetite.
Use of Buclizine as an appetite stimulant in children was approved by the Indian drug controller in June 2006 even though experts had criticised the move.
“Whereas it has been brought to the notice of the Central Government that the use of the drug Buclizine as appetite stimulant for human use is not rational; And, whereas, the matter has been examined by the Subject Expert Committee constituted by the Central Government and the said Committee has stated that no clinical trial study report on human beings to justify the use of the Buclizine as an appetite stimulant has been produced by the manufacturers and hence, the said committee has not recommended the continued marketing of the aforesaid drug as an appetite stimulant,” the drug regulator said in its December 13 order where it said that Buclizine should no longer be used as an appetite stimulant.
Originally developed by Belgium-based UCB Pharma, Buclizine is marketed in India by Mankind Pharmaceuticals. It is not approved as an appetite stimulant even in Belgium, its country of origin
The drug however can continue to be used as a medicine against allergies an “anti-histamine” and as a medicine for vertigo. To ensure that the drug is used only for these two purposes, the manufacturer has been asked to label the container of Buclizine accordingly. The order also says that on the package insert and promotional literature of Buclizine and its formulation, the words “Not to be used as appetite stimulant” should be displayed in a conspicuous manner.
Originally developed by Belgium-based UCB Pharma, Buclizine is marketed in India by Mankind Pharmaceuticals. It was approved for motion sickness in January 2010, later than the approval as an appetite stimulant. However the 2006 approvals, according to government officials, came without adequate evidence. It is not approved as an appetite stimulant even in Belgium, its country of origin.