Archive \ Volume.5 2014 Issue 6

SAFETY PROFILE OF CYCLOSPORINE

Kumar Dilip and Das Sanjita
Abstract

Background: Pharmacovigilance or drug safety is a pharmacological science related to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Cyclosporine is approved by the FDA to prevent and treat graft-versus-host disease in bone-marrow transplantation and to prevent rejection of kidney, heart, and liver transplants. As beneficial effect of cyclosporine outweighs its adverse effects, yet it may cause severe adverse effects like kidney damage, convulsions, hypertension, liver damage, tremor, hirsutism, gingival hypertrophy, hyperkalaemia, fluid retention, increased susceptibility to infections, GI symptoms. Therefore, postmarketing surveillance of cyclosporine is necessary.
Objective: This paper examines safety data from the postmarketing surveillance studies of cyclosporine.
Methods: A search was performed to identify all studies published since 2004 concerning the safety profile of cyclosporine.
Conclusions: The study lead to the conclusion that all the adverse effects associated with cyclosporine are severe but no new adverse effect other than listed in the drug literature was found.