Assessing safety trends of withdrawn medications: A data-driven pharmacovigilance approach using growth models

This study shows that adverse drug reaction (ADR) patterns, particularly those for banded/withdrawn drugs and some cancer therapies, demonstrate how safety issues alter over time. Adverse drug response (ADR) reports normally diminish after a drug is discontinued, however the rate varies. This pattern shows historical risk estimates, not those medications are safer.Analyzing the overall patterns in adverse drug reactions (ADRs) provides an additional viewpoint to established ways of monitoring drug safety. This approach allows for a more nuanced understanding of long-term safety data. The Detriment Index, a new metric based on trends, allows for the comparison of the long-term burden of adverse drug reactions (ADRs) across different medications, regardless of their regulatory history or how they are used in treatment. This method helped separate medications with lower risks, like Tamoxifen, from others that build up in the body more quickly, such as Pembrolizumab. This shows its potential for comparing safety profiles.This exploratory approach, in essence, enriches our understanding of how long post-marketing safety information lasts. It also provides a foundation for future research. This research could help support safer clinical decisions and regulatory evaluations for both pharmaceuticals that are no longer on the market and those that are still available.