Abstract
Rechallenge is defined as the readministration of a medication suspected of being a possible cause of an adverse reaction and which has been discontinued as result. It may be unintentional when the appearance of a reaction was initially not attributed to the medication. A rechallenge may be intentional when a prescriber decides that the benefit of rechallenge will outweigh its risk. When considering intentional rechallenge, one should take into account the benefit/risk balance of the suspected causative medication, and the benefit/risk balance of the best available alternative treatment or no treatment. Clinical knowledge is essential in benefit/risk assessment but there is currently no suitable tool to guide the decision on rechallenge. This article aims to propose points to consider in the creation of reaction-specific algorithms for risk assessment and management in the case of drug rechallenge.
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Acknowledgments
The authors gratefully acknowledge the input of Dr. Panos Tsintis, Medical Advisor and NDA Advisory Board Member, NDA Regulatory Science Ltd., UK; Dr. Ronald Meyboom, Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Pharmacy, Utrecht University, The Netherlands; and Dr. Irene Fermont, Vice President Risk Management & Pharmacovigilance, Advanced Drug and Device Services SAS, France. No sources of funding were used to prepare this manuscript.
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Conflict of interest
Vid Stanulovic and Mauro Venegoni declare no conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in this article. Brian Edwards declares that he is a pharmaceutical consultant working for the pharmaceutical industry.
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Stanulović, V., Venegoni, M. & Edwards, B. Intentional Rechallenge: Does the Benefit Outweigh the Risk?. Drug Saf 36, 155–161 (2013). https://doi.org/10.1007/s40264-013-0020-3
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DOI: https://doi.org/10.1007/s40264-013-0020-3