Women at Greater Risk of Adverse Reaction, Require Gender Parity in Clinical Trials
Underrepresentation in clinical trials has led to routine overmedication of women, according to a new study that shows a dramatically higher rate of adverse drug reactions (ADR) in women.
Comparing trial data and postmarket safety reports on 86 FDA-approved drugs shown to have a stronger pharmacokinetic effect on women, researchers from the University of California and the University of Chicago determined that 96 percent of the drugs also had a higher rate of ADRs in women.
“Among patients administered a standard drug dose, females are exposed to higher blood drug concentrations and longer drug elimination times than males,” the researchers conclude. “This likely contributes to the near-doubling of adverse drug reactions in female patients, raising the possibility that women are routinely overmedicated.”
ADRs encountered in the study include nausea, headache, drowsiness, depression, excessive weight gain, cognitive deficits, seizures, hallucinations, agitation and cardiac anomalies.
The researchers called the standards of evidence used to approve drugs “disappointing.” “The decades-long pattern of neglect of female animals in preclinical research and underrepresentation of women in clinical trials and research must be corrected,” they wrote, recommending regulators place a greater focus on sex parity in the drug approval process.
Six additional recommendations include:
- Posting pharmacokinetic data on all drugs currently in use on the FDA website;
- Documenting gender-based differences in reactions on drug labels and popular websites directed at the public;
- Lowering the dose given to women in trials and treatments for drugs that show a clear gender difference in reaction;
- Requiring empirical data in new drug applications to the FDA to be accompanied by statistical analysis documentation that meets the standard for publication in a peer-reviewed journal;
- Adding to the board certification process training on the clinical relevance of gender differences; and
- Paying more attention to gender-appropriate dosing in the early development stages, including animal testing.
To read the study, click here: https://bit.ly/3iILCZJ.