Posted by Michael Wonder on 25 Feb 2019
Under representation of elderly in clinical trials: an analysis of the initial approval documents in the FDA database
25 February 2019 - A cross‐sectional, structured review of publicly available initial approval documents of FDA approved drugs was performed.
The 10 most frequently on‐label prescribed drug classes, drugs with known pharmacokinetic differences in the elderly or drugs that are relatively contraindicated in elderly (e.g. anticholinergics or benzodiazepines) were included in the analyses.
In total, 1129 unique active pharmaceutical ingredients were found eligible for the analyses, of these, 506 were found in the FDA database (45%). The initial approval documents were available for 182 drugs. For the majority of the drugs, the initial approval documents in the database showed information on pharmacokinetics in elderly (n = 113; 62%).
