Gender gap in clinical trials doubles risk of women being overmedicated on prescription meds

BERKELEY, Calif. – Historically, men are more commonly included in clinical drug trials than women. The reason for this is largely due to the unfounded belief that women are more difficult to study due to hormonal fluctuations. According to a new study, that lack of representation leaves women experiencing more adverse side effects. That’s because women are likely to be overmedicated with prescriptions doses made for men, researchers say.

“When it comes to prescribing drugs, a one-size-fits-all approach, based on male-dominated clinical trials, is not working, and women are getting the short end of the stick,” Irving Zucker from University of California, Berkeley says in a release.

Researchers from UC Berkeley and University of Chicago looked at results published in thousands of medical journal articles. Their findings reveal a gender gap for 86 FDA-approved medications. In those studies, women were given the same drug doses as men. Their bodies however, had higher drug levels and it took longer to process medications.

Concerningly, study authors find women are more than twice as likely to experience adverse side effects than men. Women have worse side effects in over 90 percent of the cases. These side effects range from mild symptoms like nausea and headache to serious problems including cognitive abnormalities, seizures, hallucinations, agitation, and cardiac issues.

“Neglect of females is widespread, even in cell and animal studies where the subjects have been predominantly male,” Zucker adds.

Making prescriptions medications safer for women

Though the gender bias in science and medicine remains a concern today, there are some efforts to promote female inclusion in clinical trials. Since 2016, for example, the National Institutes of Health requires grant applicants to specify in their protocols that they would recruit male and female participants.

Despite the increase in representation of female subjects however, researchers say many studies still do not specifically look at gender differences in the outcomes. The research team argues that greater awareness of biological differences between men and women is necessary. They also believe that women should be taking lower dosages for many prescription drugs.

The study is published in Biology of Sex Differences.

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