Assessment of Overall Incidence of Esophagogastric and Swallowing/Choking Adverse Events of Alendronate Tablets

Alendronate sodium is a nitrogen-containing synthetic bisphosphonate used in the treatment and prevention of osteoporosis in postmenopausal women, treatment to increase bone mass in men with osteoporosis, treatment of glucocorticoid-induced osteoporosis and treatment of Paget's disease of bone. Alendronate sodium was approved by US FDA in 2000 later, generic applications was approved by FDA approved in 2008. Adverse reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.The present study was aimed to evaluate the overall incidence of esophagogastric and swallowing/choking adverse events for Alendronate. All case reports with adverse events/reactions reported for Alendronate Sodium from the international birth date between 17-Feb-2004 to 16-Dec-2013 were retrieved from the safety database. The  estimated  incidence  of  the  relevant  adverse  events  suggestive  of esophagogastric and swallowing/ choking in relation to the exposure data is as follows (a) Serious events - 0.0681 events per million patient days or 6.81% and (b) Non-serious events - 0.1431 events per million patient days or 14.31%. The study result have shown that the estimated incidence of the relevant adverse events suggestive of esophagogastric and swallowing/ choking in relation to the exposure data were 6.81 % serious and 14.31 % non-serious. Key words: Alendronate Tablets, Esophagogastric, Swallowing/Choking Adverse Events, Alendronate Sodium