We would like to thank the US Food and Drug Administration (FDA) for their continued efforts to make drug safety and efficacy data for subpopulations more transparent to the public. The FDA’s Drug Trials Snapshots (DTS) are a welcome addition to other drug information tools; DTS help to address a void in publicly available and readily understandable information about medical products.
In their Research Letter published in a recent issue of JAMA Internal Medicine,1 Whyte and colleagues identified inconsistencies between the package inserts (ie, drug labels) and the DTS for sex-specific safety and efficacy information. They noted that these differences (ie, lack of statements specific to sex) may be owing to legal constraints imposed on the drug label.1 We would like to highlight sections of the label where data about sex differences may appear, according to current regulations. Labeling differences among men and women can be seen in section 2 (dosage and administration). For example, with zolpidem tartrate, the recommended initial dose for women and men are different because zolpidem clearance is lower in women.2
Cook GE, Wilhelm EE. Drug Trials Snapshots and Sexless Drug Labels. JAMA Intern Med. 2017;177(12):1868. doi:https://doi.org/10.1001/jamainternmed.2017.5643
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