title: Drugs and Medical Devices: Adverse Events and the Impact on Women's Health.
abstract: A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women.
authors.affiliation: Division of Medical Toxicology, Department of Emergency Medicine, University of Massachusetts Medical School, Worcester, Massachusetts. Electronic address: jennifer.carey@umassmemorial.org.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Carey
authors.affiliation: Division of Medical Toxicology, Department of Emergency Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Nader
authors.affiliation: Division of Medical Toxicology, Department of Emergency Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.
authors.forename: Peter R
authors.initials: PR
authors.lastname: Chai
authors.affiliation: Division of Medical Toxicology, Department of Emergency Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Carreiro
authors.affiliation: Division of Medical Toxicology, Department of Emergency Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.
authors.forename: Matthew K
authors.initials: MK
authors.lastname: Griswold
authors.affiliation: Division of Medical Toxicology, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
authors.forename: Katherine L
authors.initials: KL
authors.lastname: Boyle
mesh_terms: D017277:Drug Approval; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D008297:Male; D009017:Morbidity; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D014481:United States; D014486:United States Food and Drug Administration; D016387:Women's Health
chemical_list: D004364:Pharmaceutical Preparations
keywords: medication and device safety; sex and gender