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