Sex and Gender in Adverse Drug Events, Addiction, and Placebo

  • Flavia Franconi
  • Ilaria Campesi
  • Stefano Occhioni
  • Paola Antonini
  • Michael F. Murphy
Part of the Handbook of Experimental Pharmacology book series (HEP, volume 214)

Abstract

Sex–gender-based differences in response to pharmaceutical treatments are still under evaluation but evidence already exists regarding the impact of sex–gender-related differences on drug safety profile, drug abuse/addiction, and placebo effects. For a number of drugs it is well recognized that a sex–gender dimorphic profile in terms of drug adverse effects exists and appears to be more frequent and severe in women than in men. However, it is not well known whether this is due to pharmacodynamic or pharmacokinetic differences. Indeed the optimization of therapy requires that attention is paid to single sex–gender. Numerous pharmacokinetic, pharmacodynamic, and sociocultural differences between women and men in drug abuse have been described. Here we focus on sex–gender differences in alcoholism and nicotine addiction. The relevance of sex and gender differences in addiction appear to be relevant. Specific programs aimed to address addicted women’s specific needs (child care, pregnancy, housing, and violence and others) are recommended. Finally, this article discusses the possible effect of sex–gender on placebo response in the light of the more significant recent literature evidencing that studies are urgently required in order to better understand the role of sex–gender on placebo mechanism and its impact on randomized clinical trials outcomes.

Keywords

Adverse reactions Aging Sociocultural Addiction Stress Pregnancy Placebo Pain 

Abbreviations

SGD

Sex–gender differences

ADE

Adverse drug events

RCT

Randomized controlled trials

ADH

Alcohol dehydrogenase

OC

Oral contraceptives

HRT

Hormone replacement therapy

Notes

Acknowledgments

Supported by grants “La Medicina di Genere come Obiettivo Strategico per la Sanità Pubblica: l‘Appropriatezza della Cura per la Tutela della Salute della Donna from Ricerca Finalizzata Ministero della Salute” 2007 and by a grant of Legge Regionale 7 agosto 2007, no. 7: “Promozione della ricerca scientifica e dell’innovazione tecnologica in Sardegna.”

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Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • Flavia Franconi
    • 1
    • 2
  • Ilaria Campesi
    • 1
    • 2
  • Stefano Occhioni
    • 1
    • 2
  • Paola Antonini
    • 3
  • Michael F. Murphy
    • 3
  1. 1.Department of Biomedical SciencesUniversity of SassariSassariItaly
  2. 2.National Laboratory of Sex-Gender Medicine of the National Institute of Biostructures and BiosystemsOsiloItaly
  3. 3.Worldwide Clinical TrialsKing of PrussiaUSA

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