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. 2024 Sep;58(5):946-952.
doi: 10.1007/s43441-024-00673-y. Epub 2024 Jun 17.

Overdosage Section in US and EU Labeling

Sarah Condon  1 , Thomas G Cantu  2 , Antony Constantinou  3 , Erin C Degnan  2 , Monica Lungu  3 , Marcella G Paglione  2 , Shreya J Parikh  2 , Joanna Szewczyk  4
Affiliations

Overdosage Section in US and EU Labeling

Sarah Condon et al. Ther Innov Regul Sci. 2024 Sep.

Abstract

The Prescribing Information (PI) in the United States (US) and the Summary of Product Characteristics (SmPC) in the European Union (EU) are approved by the US Food & Drug Administration (FDA), and the European Medicines Agency (EMA), respectively. The inclusion of overdosage information in these documents is a regulatory requirement in both regions. This research evaluates the content of the overdosage section of US and EU labeling. The overdosage sections of labels for drugs approved in the US in three time periods were analyzed: 2000-2001, 2010-2011, and 2020-2021. EU labels for these same products were also reviewed if registered through the Centralized Procedure. Data collection and analyses were performed using a predefined questionnaire, focusing on adherence to regulatory requirements and identifying areas where additional regulatory guidance may be beneficial. The findings indicate that the content of the overdosage sections largely comply with the regulatory requirements of their respective regions. Fewer than half of the labels included information on supratherapeutic doses observed from clinical studies, risk factors for overdose or population specific data associated with overdose. Inconsistencies were noted concerning the incorporation of animal data when human data were available, in addition to the referencing of Poison Centers. The overall utility of non-specific treatment recommendations, in addition to gastric lavage is discussed. While the content of the overdosage section generally aligns with regulatory expectations, additional regulatory guidance could enhance consistency in how this section of labeling is presented and clarify expectations to improve its usefulness for health care professionals (HCPs).

Keywords: Labeling; Overdosage; Regulatory Affairs; Safety.

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Conflict of interest statement

Sarah Condon, Tom G. Cantu, Antony Constantinou, Eric C. Degnan, Monica Lungu, Marcella G. Paglione, Shreya J. Parikh, and Joanna Szewczyk are employees of and hold shares in GSK.

References

    1. Specific requirements on content. And format of labeling for human prescription drug and biological products described in § 201.56(b)(1). Title 21. Code Fed Regulations Pt. 201.57(c)(11).
    1. Specific requirements on. Content and format of labeling for human prescription drug and biological products; older drugs not described § 201.56(b)(1). Title 21. Code of Federal Regulations. Pt. 201.80(i).
    1. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use. Official Journal L-311, 28. Nov 2004; pp. 67–128.
    1. Notice to Applicants. A Guideline on Summary of Product Characteristics (SmPC). Sep 2009. Revision 2.
    1. European Medicines Agency. Product-information templates– Human. QRD product-information annotated template (English) version 10.3. https://www.ema.europa.eu/en/documents/template-form/qrd-product-informa....

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