Trends of phosphodiesterase 5 inhibitors, glibenclamide & sibutramine adverse drug reaction reporting in Malaysia, Australia and Canada / Hasnida Mohd Ali

Background: Phosphodiesterase 5 inhibitors such as sildenafil was originally developed for angina treatment, then discovered to have significant effect on erectile dysfunction. Sildenafil claimed to have high safety profile, but there are reports of serious adverse drug reactions (ADRs). Glibenclamide is an antidiabetic drug under sulphonylurea class. Sulphonylureas are the most prescribed oral hypoglycemic agents in Malaysia. Sibutramine is a serotonin, norepinephrine and dopamine reuptake inhibitor. It was used in obesity treatment and was withdrawn from the market in 2010. In Malaysia, PDE 5 inhibitors, glibenclamide & sibutramine are the most common poison found in the cancelled traditional complementary products within 2008-2013. There are limited knowledge whether this products are associated withADRs. Objective: This study aims to determine and compare the trends of ADR reporting of PDE 5 inhibitors, glibenclamide, and sibutramine in Malaysia, Australia and Canada. Method: Data of ADR reports of PDE 5 inhibitors, glibenclamide and sibutramine ADR reporting were collected from the Malaysia National Pharmaceutical Control Bureau (NPCB), Australia Therapeutic Goods Administrations website and Health Canada website. All data were collected from 2008-2014 for PDE 5 inhibitors and glibenclamide, and 2008-2012 for sibutramine. Then, the data were transferred onto data collection forms and ADR terms were classified according to Medical Dictionary for Regulatory (MedDRA). All ADRs were identified whether known or unknown ADR based on product information. Descriptive analyses were carried out by using Microsoft Excel software version 2013. Result: Generally, there is a decreasing trends of PDE 5 inhibitors ADR reports in Malaysia, Australia and Canada from 2008 to 2014. Nervous system diorders, eye disorders and cardiovascular disorders are the common ADRs reported associated with PDE 5 inhibitors. Blindness is the similar ADRs reported in all three countries.