Assessment of drug-induced adverse events reported for transgender population in India

Purpose: To assess the ADRs reported (2010-2020) for transgender population in India. Methods: : The study was based on the surveillance data received during the study period at Indian Pharmacopoeia Commission (IPC), as IPC is authorized for collating and analyzing ADRs submitted by healthcare professionals, marketing authorization holders and consumers under the Pharmacovigilance Programme of India (PvPI). Results: : We analyzed the Individual Case Safety Reports (ICSRs) reported for transgender population from January 2010 to December 2020. 94 ICSRs were found to be associated with the use of pharmaceutical drugs in the transgender population and out of these 2.7% were found to be serious in nature. The highest percentages of reports (47%) were from the age group of 20-30 years and the trend showed a consistent decline in ICSRs as the age of transgenders progressed. Reactions like mouth sore, oesophageal stenosis and oropharyngeal candidiasis were found only in transgender patients due to the use of Anti-retroviral drugs. Considering the spectrum of this minority gender within the general population. Discussion: The results of the present study may help to understand medication safety in transgender population. This article would stimulate the ADRs reporting for transgender group by other countries to their national pharmacovigilance centres.