5. Limitations
It is important to acknowledge the limitations of this study. First, the
major is the underreporting of AEs by healthcare professionals, leading
to incomplete data and an inaccurate representation of the true safety
profile of drug. Second, the quality of data in pharmacovigilance
databases can vary and hinder the analysis and interpretation of safety
signals. Third, pharmacovigilance data often lacks comprehensive
information about confounding factors that could contribute to AEs.
Therefore, it is important to consider these limitations when
interpreting pharmacovigilance data, as well as making decisions
regarding drug and risk management. However, this study identified
signals, such as hemiplegic migraine, asthenia, constipation, and
flatulence, that are previously unknown or underestimated risk
associated with pirfenidone or nintedanib, and provides an opportunity
to assess ADRs that may not be detected during pre-approval clinical
trials, which typically involve a limited number of patients.