Drug-associated cardiovascular risks: A retrospective evaluation of withdrawn drugs.

Abstract

A considerable number of drugs were withdrawn from the world market in the last decades due to safety reasons.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 The scope of the present study was to focus on cardiovascular adverse reactions of 61 withdrawn medicinal products, as well as 40 additional drugs withdrawn due to non-cardiovascular toxicity, while being cardiovascular agents themselves. A detailed web-based data search was held to draw a list of withdrawn pharmaceutical products from the pharmaceutical market by regulatory authorities between 1950 and 2017 due to safety reasons. A total of 464 medicinal products were withdrawn from the pharmaceutical markets between 1950 and 2017 due to safety reasons.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.