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Comparison of Pregnancy and Lactation Labeling for Attention-Deficit Hyperactivity Disorder Drugs Marketed in Australia, the USA, Denmark, and the UK

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Abstract

Background

Pregnancy and lactation labeling is presented in the officially recognized product information (PI) accompanying prescription drugs to ensure appropriate prescribing in pregnant and breastfeeding women.

Objective

The aim of this study was to analyze pregnancy and lactation labeling in PI for attention-deficit hyperactivity disorder drugs marketed across countries and to compare this information with respect to consistency and discrepancy.

Methods

We manually surveyed PI for atomoxetine, methylphenidate, and modafinil marketed by the same pharmaceutical companies in Australia, the USA, Denmark, and the UK. We extracted information regarding data sources (animal and human data), risk to the fetus or breastfed child, excretion in breast milk, and recommendations for use. The extracted information was then analyzed and compared with respect to consistency and discrepancy.

Results

Inter-country discrepancies were identified with respect to both animal and human data sources presented, types of risks listed in association with exposure during pregnancy and lactation, information regarding excretion of the drug in breast milk, and recommendations for use. Consistency was identified between PI for drugs marketed in the EU.

Conclusion

The study suggests that pregnancy and lactation labeling in PI for drugs marketed by the same pharmaceutical companies depend on the country of marketing; this raises concern about the reliability of PI documents as a useful source of information for appropriate prescribing during pregnancy and lactation. Discrepancies in this information can potentially lead to inappropriate prescribing in pregnant and breastfeeding women, who may expose their fetuses and breastfed children to unnecessary risks. At the same time, unjustified warnings against breastfeeding may result in children being unnecessarily weaned from being breastfed.

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Notes

  1. The Australian Therapeutic Goods Administration and the US Food and Drug Administration classify risk associated with medication exposure during pregnancy into seven (A, B1, B2, B3, C, D, X) and five (A, B, C, D, X) categories, respectively, based on the availability of human and animal data. A is considered the safest category while the category X is completely contraindicated.

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Author Contribution

All authors were involved in the conception and design of this study; PW manually extracted pregnancy and lactation labeling information from the PIs investigated in this study, conducted the analysis, and wrote the first version of the manuscript; LA and EHH validated the extracted data; LA and EHH provided critical revision of the content and approved the final version of the manuscript.

Conflict of interests

Pernille Warrer, Lise Aagaard, and Ebba Holme Hansen have no conflicts of interest that are directly relevant to the content of this study.

Funding

This study was conducted as part of a PhD project financed by the PharmaSchool, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.

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Authors and Affiliations

  1. Section for Social and Clinical Pharmacy, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, 2100, Copenhagen, Denmark

    Pernille Warrer & Ebba Holme Hansen

  2. Section for Clinical Pharmacology, Faculty of Health Sciences, Institute of Public Health, University of Southern Denmark, Odense, Denmark

    Lise Aagaard

  3. Danish Pharmacovigilance Research Project (DANPREP), Copenhagen, Denmark

    Pernille Warrer, Lise Aagaard & Ebba Holme Hansen

Authors
  1. Pernille Warrer
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  2. Lise Aagaard
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  3. Ebba Holme Hansen
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Corresponding author

Correspondence to Pernille Warrer.

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Warrer, P., Aagaard, L. & Hansen, E.H. Comparison of Pregnancy and Lactation Labeling for Attention-Deficit Hyperactivity Disorder Drugs Marketed in Australia, the USA, Denmark, and the UK. Drug Saf 37, 805–813 (2014). https://doi.org/10.1007/s40264-014-0215-2

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  • DOI: https://doi.org/10.1007/s40264-014-0215-2

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