Regulatory adverse drug reaction analyses support a temporal increase in psychiatric reactions after initiation of cystic fibrosis combination modulator therapies.

ABSTRACT

INTRODUCTION: Despite improved outcomes for many people with cystic fibrosis, there have been reports of adverse neuropsychiatric effects of modulator therapy. The aim of this research is to define temporal associations in adverse drug reaction (ADR) reports for available CFTR modulators. METHODS: Methods include an analysis of the UK Yellow Card Scheme data for ADRs through accessing interactive Drug Analysis Profiles (iDAPs) to define temporal trends in absolute and proportional counts. RESULTS: Since the introduction of ETI, there has been an increase in the absolute number of psychiatric ADRs reported as well as a statistically significant increase in the proportion of psychiatric ADRs in the pre-ETI and post-ETI periods. CONCLUSION: In the post-ETI period, psychiatric ADRs are the most prevalent ADR reported via the Yellow Card scheme. Despite an unclear mechanism, there is significant clinical relevance in counselling and monitoring regarding psychiatric effects of CFTR modulator therapy.