Drugs and Medical Devices: Adverse Events and the Impact on Women's Health
Name:
Publisher version
View Source
Access full-text PDFOpen Access
View Source
Check access options
Check access options
Authors
Carey, Jennifer L.Nader, Nathalie
Chai, Peter R.
Carreiro, Stephanie
Griswold, Matthew K.
Boyle, Katherine L.
UMass Chan Affiliations
Department of Emergency Medicine, Division of Medical ToxicologyDocument Type
Journal ArticlePublication Date
2017-01-01Keywords
medication and device safetysex and gender
UMCCTS funding
Analytical, Diagnostic and Therapeutic Techniques and Equipment
Women's Health
Metadata
Show full item recordAbstract
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.Source
Clin Ther. 2017 Jan;39(1):10-22. doi: 10.1016/j.clinthera.2016.12.009. Epub 2017 Jan 7. Link to article on publisher's site
DOI
10.1016/j.clinthera.2016.12.009Permanent Link to this Item
http://hdl.handle.net/20.500.14038/28543PubMed ID
28069260Related Resources
ae974a485f413a2113503eed53cd6c53
10.1016/j.clinthera.2016.12.009