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Review
. 2018 Sep 5;6(2):196-202.
doi: 10.14744/nci.2018.44977. eCollection 2019.

Drug-associated cardiovascular risks: A retrospective evaluation of withdrawn drugs

Kumsal Kocadal  1 , Sahan Saygi  1 , Fehmi Burak Alkas  1 , Semra Sardas  2
Affiliations
Review

Drug-associated cardiovascular risks: A retrospective evaluation of withdrawn drugs

Kumsal Kocadal et al. North Clin Istanb. .

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A considerable number of drugs were withdrawn from the world market in the last decades due to safety reasons.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 The scope of the present study was to focus on cardiovascular adverse reactions of 61 withdrawn medicinal products, as well as 40 additional drugs withdrawn due to non-cardiovascular toxicity, while being cardiovascular agents themselves. A detailed web-based data search was held to draw a list of withdrawn pharmaceutical products from the pharmaceutical market by regulatory authorities between 1950 and 2017 due to safety reasons. A total of 464 medicinal products were withdrawn from the pharmaceutical markets between 1950 and 2017 due to safety reasons.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

Keywords: Cardiovascular toxicity; drug safety; drug withdrawal.

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Conflict of interest statement

Conflict of Interest: The authors declare that they have no conflict of interest.

Figures

FIGURE 1
FIGURE 1
Cardiovascular classes of withdrawn drugs.
FIGURE 2
FIGURE 2
Pharmacological classes of drugs withdrawn in response to their cardiovascular toxicity.
See this image and copyright information in PMC

References

    1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients:a meta-analysis of prospective studies. JAMA. 1998;279:1200–5. - PubMed
    1. UMC - Members. [Accessed May 27, 2017]. Available at: https://www.who-umc.org/global-pharmacovigilance/members/
    1. Uppsala:the Uppsala Monitoring Center - Uppsala Reports October 2005. 1st ed. [Accessed May 2, 2019]. p. 5. Available at: https://www.who-umc.org .
    1. Onakpoya IJ, Heneghan CJ, Aronson JK. Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions:a systematic review of the world literature. BMC Med. 2016;14:10. - PMC - PubMed
    1. Sultana J, Cutroneo P, Trifirò G. Clinical and economic burden of adverse drug reactions. J Pharmacol Pharmacother. 2013;4:S73–7. - PMC - PubMed

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