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.

Evidence Map: Reporting of Results by Sex or Gender in Randomized, Controlled Trials with Women Veteran Participants (2008 to 2018)

“…The proportion of trials that reported results by sex or gender in this review (25%) was within the range of previously published reviews of non-veteran-specific RCTs from a similar time frame (13%-48%; Avery & Clark, 2016;Geller, Adams, & Carnes, 2006;Geller et al, 2011;Phillips & Hamberg, 2016). Certain study types, such as those evaluating pharmacologic and device interventions, may be particularly important targets for sex and gender research equity (Carey et al, 2017). In 2001, the U.S. General Accounting Office reported that 8 of 10 drugs removed from the market in the preceding years had more significant (and some potentially fatal) adverse effects for women than men (Heinrich, Gahart, Rowe, & Bradley, 2001).…”

Salt and blood pressure in Africans

“…Education & Teaching (Carey et al, 2017) and the historic exclusion of women from clinical trials and even the exclusion of female mice from pre-clinical research (Karp and Reavey, 2018) are known driving factors for why drugs fail. A study in 2001 found that of the 10 drugs withdrawn from the market since 1997, eight posed greater health risks for women than men (Heinrich, 2001).…”

Do you see what I see? Viewing the world through the prism of colour blindness

“…The recent spotlight on clinical trials and drug responses is a powerful example of why trial design and research needs to be disrupted. Sex differences in drug responses, including adverse side effects, are now recognised (Carey et al, 2017) and the historic exclusion of women from clinical trials and even the exclusion of female mice from pre-clinical research (Karp and Reavey, 2018) are known driving factors for why drugs fail. A study in 2001 found that of the 10 drugs withdrawn from the market since 1997, eight posed greater health risks for women than men (Heinrich, 2001).…”