Sex and gender in adverse drug events, addiction, and placebo.

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.