Copyright © 2026 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
@article{205623,
author = {Yuvraj Singh Rajput},
title = {Pharmacovigilance and Post-Marketing Drug Withdrawals: National and International Experiences},
journal = {International Journal of Innovative Research in Technology},
year = {2026},
volume = {13},
number = {1},
pages = {7108-7113},
issn = {2349-6002},
url = {https://ijirt.org/article?manuscript=205623},
abstract = {Pharmacovigilance is an essential field dedicated to monitoring the safety and effectiveness of pharmaceuticals following their approval and market introduction. This discipline is crucial for identifying, evaluating, and mitigating adverse drug reactions (ADRs) that may not have been apparent during initial clinical trials. Even with rigorous pre-marketing assessments, certain medications can present unexpected risks, which may necessitate their removal from the market to protect public health on a global scale. The importance of pharmacovigilance cannot be overstated, as it serves as a safeguard for patients and health care systems alike. This comprehensive review delves into various international experiences concerning the withdrawal of drugs from the market as a result of pharmacovigilance efforts. This highlights the methodologies employed to detect adverse reactions, the regulatory frameworks that govern these processes, and notable instances of drug withdrawals that have occurred due to safety concerns. By examining these cases, the review underscores the challenges faced by pharmacovigilance systems worldwide, including issues related to data collection, reporting, and the integration of new technologies in monitoring drug safety. Furthermore, the document emphasizes the necessity of robust post-marketing surveillance and the application of advanced data mining techniques to enhance the detection of potential safety issues. It advocates for increased international collaboration among regulatory bodies, healthcare professionals, and pharmaceutical companies to improve pharmacovigilance practices. By sharing insights and recommendations, this review aims to contribute to the ongoing efforts to strengthen pharmacovigilance systems, ultimately leading to better patient safety and improved public health outcomes.},
keywords = {Pharmacovigilance, Post-Marketing Surveillance, Drug Withdrawals, Adverse Drug Reactions (ADRs), Patient Safety, Regulatory Affairs, Signal Detection.},
month = {June},
}
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