Incidence of myocarditis caused by drugs for ulcerative colitis examined
using VigiBase, a spontaneous adverse drug reaction reporting database
Abstract
Aim: To investigate the association between ulcerative colitis drugs and
myocarditis as an adverse event based on the detection of adverse event
signals using a spontaneous reporting database. Methods: We searched for
five drugs, namely mesalazine, sulfasalazine, azathioprine,
mercaptopurine, and budesonide, listed in the treatment guidelines for
ulcerative colitis, using VigiBase. The information component was
calculated. A signal was considered present when the lower limit of the
95% confidence interval of the information component exceeded zero.
Results: The total number of VigiBase reports and of myocarditis as a
target adverse event was 32 520 983 and 61 567, respectively. No trend
was identified based on age or sex. Analysis of the five ulcerative
colitis drugs for severity in VigiBase showed that most patients
recovered, and deaths were few. However, the time to onset of adverse
drug reactions varied among drugs. Conclusion: Mesalazine signals were
detected regardless of age or sex. This suggests that myocarditis, an
adverse event, may be a potential complication regardless of patient
characteristics. These results warrant multifaceted investigations,
including basic and clinical studies, on the characteristics of each
drug with regard to the development of myocarditis as an adverse event
caused by ulcerative colitis drugs.