Buclizine is back again! This time as a pediatric appetite stimulant

Abstract

Sir, Buclizine is an antihistaminic drug which has been tried in several medical conditions with few or no success. These include motion sickness, allergic conditions, vomiting, migraine, diabetes, insomnia, etc.[1,2] Recently, we came across a campaign by a well-known pharmaceutical company for this forgotten drug, for an entirely different indication. The syrup formulation of this drug is being promoted as an incredible appetite stimulant for weight gain in children. Although this drug was introduced for this indication a few years back, it was not extensively marketed until earlier this year. The representatives issued a promotional literature containing scientific evidence in support of using this drug. The pamphlet mentioned three trials including the one which compares the weight gain due to cyproheptadine. All the three trials were underpowered with doubtful methodology and exaggerated claims and the most recent one of them was published in the year 1991.[3,4] No articles were published from indexed journals. There were no trials conducted thereafter for almost 20 years now. We did an unbiased literature search to check if buclizine is really indicated for this purpose. A Pubmed search revealed no published articles on buclizine and weight gain in the last 40 years, and only a very few before 1970, mostly untraceable non-English articles.[5] None of the standard textbooks of Pharmacology mentioned that this drug is indicated for appetite stimulation. We concluded that there is no convincing literature regarding the use of this drug. There are few questions to be answered. Do children require appetite stimulant at all? This is still a matter of debate, but most authors do not accept using appetite stimulants routinely for all children to enhance growth. Even in children with failure to thrive, appetite stimulants are never a management option.[6] Is the available proof enough to market this drug? Though Buclizine has been used for this indication for some years now, the current spurt in promotional activity may be due to a recent change in brand's ownership. By any standards of evidence-based medicine, the currently available evidence is grossly insufficient to recommend its use. Why were no trials conducted recently? On what basis the Drugs Controller General of India (DCGI) would have approved this drug? Buclizine has been licensed for marketing in India long time back probably for another indication. This is being misused now, as the marketing approvals were not indication specific during that time. Though DCGI has no further role here as the drug is already marketed, it does however have the moral authority to check irrational and exaggerated claims. Since most of the mothers complain about their child's weight in spite of normal weight gain, prescriptions of drugs like buclizine are likely to increase. In addition, there is a risk of this drug being used “over the counter.ȁ Evidence from large-scale multicentric randomized controlled clinical trials are needed before this drug can be used as a pediatric appetite stimulant. Until then the onus is on the prescribing doctor to decide if the available evidence justifies use of pediatric appetite stimulants in general and buclizine in particular.