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Participant Imbalance leads to Overmedicating of Females

Aug 13, 2020 by CenTrial

Gender bias in trials leads to overmedicating women

Historically, clinical trials have been conducted on men. Unfortunately, this can lead to the FDA approving medications that are far too strong for females to take.

Researchers have discovered 86 approved medications from antidepressants, analgesics, anti-seizure drugs, to heart medications, that could be overmedicating women because clinical trials are not diverse enough and are not taking into account the biological differences between men and women.

The studies found that when women were given the same drug doses as men, there was a higher concentration of the drug in their blood, and it took longer for the drug to be expelled from their bodies.

For example, the recommended dosage for Ambien, a sleep medication, has been cut in half for women after it was found that women experienced next-morning drowsiness, cognitive impairment, and increased traffic accidents while taking the full dose of the medication.

Women experienced adverse drug reactions twice as often as men, and worse side effects in more than 90% of the trials, including symptoms like headache, nausea, depression, seizures, and cardiac anomalies.

"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.

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