Kocadal Kumsal, Saygi Sahan, Alkas Fehmi Burak, Sardas Semra
Department of Toxicology, Near East University Faculty of Pharmacy, Nicosia, TRNC.
Department of Toxicology, Istinye University Faculty of Pharmacy, Istanbul, Turkey.
North Clin Istanb. 2018 Sep 5;6(2):196-202. doi: 10.14744/nci.2018.44977. eCollection 2019.
A considerable number of drugs were withdrawn from the world market in the last decades due to safety reasons. A retrospective review of withdrawals is important in determining the adequacy of regulations regarding the safety and efficacy of drugs. The scope of the present study was to focus on cardiovascular adverse reactions of 61 withdrawn medicinal products, as well as 40 additional drugs withdrawn due to non-cardiovascular toxicity, while being cardiovascular agents themselves. A detailed web-based data search was held to draw a list of withdrawn pharmaceutical products from the pharmaceutical market by regulatory authorities between 1950 and 2017 due to safety reasons. A total of 464 medicinal products were withdrawn from the pharmaceutical markets between 1950 and 2017 due to safety reasons. Hepatotoxicity was the most commonly reported adverse drug reaction (ADR) that led to withdrawal, followed by immune-related reactions, neurotoxicity, and cardiovascular toxicity. The underlying mechanisms leading to cardiovascular toxicity should be investigated in depth to avoid the use of risky drugs for long periods, especially in consideration of the fact that some cardiovascular drugs persisted in the market for many decades. Furthermore, improved reporting of suspected adverse reactions and stricter regulations will lead to quicker detection of ADRs, thus emphasizing the importance of this public health problem and highlighting the need for improved "early warning systems" to manage the risks of high-risk drugs.
在过去几十年中，相当数量的药物因安全原因被撤出全球市场。对撤市药物进行回顾性审查对于确定药品安全与有效性相关法规是否充分至关重要。本研究的范围聚焦于61种撤市药品的心血管不良反应，以及另外40种虽本身为心血管药物但因非心血管毒性而撤市的药物。通过基于网络的详细数据检索，列出了1950年至2017年期间监管机构因安全原因从药品市场撤出的药品清单。1950年至2017年期间，共有464种药品因安全原因被撤出药品市场。肝毒性是导致撤市的最常见药物不良反应（ADR），其次是免疫相关反应、神经毒性和心血管毒性。应深入研究导致心血管毒性的潜在机制，以避免长期使用有风险的药物，特别是考虑到一些心血管药物在市场上持续存在数十年这一事实。此外，改进疑似不良反应的报告并加强监管将有助于更快地发现ADR，从而凸显这一公共卫生问题的重要性，并强调需要改进“早期预警系统”以管理高风险药物的风险。
