药物警戒杂志

抽象的

Weight gain in Association with Insulin Use - An Analysis of Individual Case Safety Reports an Indian Database

Prasad Thota, Kalaiselvan Vivekanandan, Jai Prakash, Surinder Singh and Gyanendra Nath Singh

Background: The Central Drugs Standard Control Organization’s (CDSCO) Pharmacovigilance Programme of India for National Drug Monitoring, maintained by the National Coordination Centre (NCC)- Indian Pharmacopoeia Commission, has 60 member AMCs (Adverse drug reaction Monitoring Centers) contributing individual case safety reports (ICSRs) from their existing regional Pharmacovigilance centers; these reports are stored in the Indian patients ICSR database, VigiFlow. A continuous increase of ICSRs with weight-increase is suspected to be connected with insulin use has been observed in VigiFlow; however only limited information has been published on this topic.

Objective: To examine in detail the association between Insulin and weight gain by outlining the characteristics of the accumulated reports in VigiFlow.

Method: An analysis of 24,006 ICSRs in VigiFlow, from 15 April 2011to 31 October 2012, where insulin was suspected of causing weight gain.

Results: Insulin has been suspected of being involved in the development of weight gain in 33 patients, as reported by 60 AMCs. The age of the patients ranged between 15 years to 73 years (mean 37 years), with a predominance (56%) of patients >30 years of age and 32 patients were male. In 33 reports, Insulin was the only drug suspected by the reporter, and in all 33 reports, Insulin was the sole reported drug. Commonly concomitant drugs were other oral anti diabetic drugs. In 33 patients, weight gain has reported as the single event and the relation between the drug and reaction was possible according to WHO causality scale. None of the patients were reported to have had a recurrence of weight gain on re-administration of Insulin.

Conclusions: The NCC continues to receive reports of weight gain associated with the use of Insulin. Although weight gain may not be regarded as serious from a regulatory perspective, this adverse reaction has the potential to affect compliance resulting in decreased efficacy of the treatment regimen and detrimental effects on patient health outcomes.