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Conflicting meal recommendations for oral oncology drugs: pose risks to patient care?

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Abstract

Purpose

The labeling information, authorized by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), is expected to guide the method of drug administration with reference to meal intake, aiming at ensuring favorable safety profile and achieving optimal drug exposure. However, interactions between meals and a specific oral anticancer medication are complicated in that could be strongly affected by inter-individual variability in pharmacokinetics, meal compositions, and the timing of drug administration with respect to meal intake, which could lead to conflicting meal recommendations between regulatory authorities. The primary objective of this article was to systemically identify the conflicting food recommendations for oral antineoplastic drugs and explore the potential risks associated with these conflicting recommendations to patient-centered care.

Methods

We revisited, compared, and analyzed systemically the publicly accessible regulatory documents of the orally administered, anticancer drugs from the FDA and the EMA.

Results

After revisiting the labeling information and other regulatory documents of 43 oral oncology agents authorized by FDA during 2010–2016 and by the EMA at the time of this analysis finalized (December 2017), conflicting or inconsistent meal recommendations between the EMA and FDA were identified in 14% (6 of 43) oral anticancer drugs.

Conclusion

Conflicting food recommendations between regulatory authorities could have a large impact on anticancer treatment and patients’ quality of life, leading to suboptimal clinical outcomes. As the most important source of dosing instructions, the labeling information should be regularly recalibrated to provide consistent and informative instructions for drug intake in relation to meals, minimizing unintended interactions with meals and improving patient compliance and adherence. Further efforts on harmonizing food recommendations between regulatory agencies are highly warranted to assure optimal outcomes for individual patients. Moreover, meal-drug interaction studies should be conducted as early as possible to inform the dosing schedules of the subsequent phase 2 and phase 3 trials, thereby facilitating regulatory decision-making in regard to the method of drug administration.

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Funding

This work was partly supported by the National Natural Science Foundation of China (No. 81603209).

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Authors and Affiliations

  1. Subei People’s Hospital, Yangzhou University, Yangzhou, 225001, China

    Guo Yu & Guo-Fu Li

  2. Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, 32610, USA

    Guo Yu & Yan Gong

  3. Institute of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha, 410078, China

    Guo Yu & Hong-Hao Zhou

  4. Department of Pharmacy, Hainan General Hospital, Haikou, China

    Dan-Na Wu

  5. Department of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, FL, 32610, USA

    Guo-Fu Li

  6. Center for Drug Clinical Research, Shanghai University of Chinese Medicine, Shanghai, 201203, China

    Guo-Fu Li

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  1. Guo Yu
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  2. Dan-Na Wu
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  3. Yan Gong
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Correspondence to Guo-Fu Li.

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Yu, G., Wu, DN., Gong, Y. et al. Conflicting meal recommendations for oral oncology drugs: pose risks to patient care?. Eur J Clin Pharmacol 74, 833–842 (2018). https://doi.org/10.1007/s00228-018-2439-z

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  • DOI: https://doi.org/10.1007/s00228-018-2439-z

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