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, according to new research released by the University of California, Berkeley (UC Berkeley).
Researchers from UC Berkeley and the University of Chicago 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 the 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.
In more than 90 percent of cases, women experienced worse side effects. 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.
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, the study said.
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.