Lack of females in drug dose trials leads to overmedicated women
Gender gap leaves women experiencing adverse drug reactions nearly twice
as often as men, study shows

Date:
August 12, 2020
Source:
University of California - Berkeley
Summary:
Women are more likely than men to suffer adverse side effects of
medications because drug dosages have historically been based on
clinical trials conducted on men, suggests new research.



FULL STORY ========================================================================== Women are more likely than men to suffer adverse side effects of
medications because drug dosages have historically been based on clinical trials conducted on men, suggests new research from the University of California, Berkeley, and the University of Chicago.


========================================================================== Researchers analyzed data from several thousand medical journal articles
and found clear evidence of a drug dose gender gap for 86 different
medications approved by the Federal Drug Administration (FDA), including antidepressants, cardiovascular and anti-seizure drugs and analgesics,
among others.

"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," said study lead author Irving
Zucker, a professor emeritus of psychology and of integrative biology
at UC Berkeley.

The findings, published in the journal Biology of Sex Differences,
confirm the persistence of a drug dose gender gap stemming from a
historic disregard of the fundamental biological differences between
male and female bodies, Zucker said.

Women in the studies analyzed by Zucker and University of Chicago
psychologist Brian Prendergast were given the same drug dose as the men,
yet had higher concentrations of the drug in their blood, and it took
longer for the drug to be eliminated from their bodies.

And, in more than 90% of cases, women experienced worse side effects,
such as nausea, headache, depression, cognitive deficits, seizures, hallucinations, agitation and cardiac anomalies. Overall, they were
found to experience adverse drug reactions nearly twice as often as men.



==========================================================================
For decades, women were excluded from clinical drug trials based, in
part, on unfounded concerns that female hormone fluctuations render
women difficult to study, Zucker said.

Moreover, until the early 1990s, women of childbearing age were kept
out of drug trial studies due to medical and liability concerns about
exposing pregnant women to drugs and risking damage to their fetuses --
as was the case in the 1950s and '60s with thalidomide, which caused
limb birth defects in thousands of children worldwide.

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

Zolpidem, the popular sleep medication marketed as Ambien, lingers longer
in the blood of women than of men, causing next-morning drowsiness,
substantial cognitive impairment and increased traffic accidents, Zucker
said. For these reasons, the FDA in 2013 halved the recommended dosage prescribed to women.

In acknowledging the widespread male bias in both human and animal
studies, the National Institutes of Health mandated in 2016 that grant applicants would be required to recruit male and female participants in
their protocols.

While the inclusion of females in drug trials has increased in recent
years, many of these newer studies still fail to analyze the data for
sex differences, Zucker said.

Going forward, Zucker and Prendergast make the case for a broader
awareness - - in medical research, the medical profession and the pharmaceutical industry - - of the biological sex and gender differences
that put women at a disadvantage when taking prescription drugs. They
recommend dosage reductions for women for a wide range of drugs.


========================================================================== Story Source: Materials provided by
University_of_California_-_Berkeley. Original written by Yasmin
Anwar. Note: Content may be edited for style and length.


========================================================================== Journal Reference:
1. Irving Zucker, Brian J. Prendergast. Sex differences in
pharmacokinetics
predict adverse drug reactions in women. Biology of Sex Differences,
2020; 11 (1) DOI: 10.1186/s13293-020-00308-5 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2020/08/200812161318.htm

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