Jack Iwashyna 🫁

ok, like half of the useful non-antibiotic #ICU #drugs are apparently #UnapprovedByFDA

Source: #RaviGupta #JoeRoss in https://pubmed.ncbi.nlm.nih.gov/28944731/

#WTF
#atropine #epinephrine #hydrocodone #levothyroxine #morphine #nitroglycerine #oxycodone #pancrelipase #phenylephrine #vasopressin

#MedMastodon

The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States - PubMed

This project was not supported by any external grants or funds. Gupta was supported by the Yale University School of Medicine Office of Student Research at the time of this study. Dhruva is supported by the Department of Veterans Affairs as part of the Robert Wood Johnson Foundation Clinical Scholar …

PubMed
Nov 21, 2022 at 2:47pmWeb
Show threadJack Iwashyna 🫁Nov 21, 2022
and the data to fix this was not amazing
Show threadJack Iwashyna 🫁Nov 21, 2022

#RaviGupta

"Specific manufacturers that received direct FDA warning letters also were found to have raised prices after obtaining approval for drug products they had already marketed without approval. In addition, all but 2 drugs that received new approval through voluntary compliance or after UDI regulatory action were supported by literature reviews and bioequivalence to older drug products, not new clinical trial evidence"

Source: https://pubmed.ncbi.nlm.nih.gov/28944731/ #Drugs #Pharma #DrugShortage

The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States - PubMed

This project was not supported by any external grants or funds. Gupta was supported by the Yale University School of Medicine Office of Student Research at the time of this study. Dhruva is supported by the Department of Veterans Affairs as part of the Robert Wood Johnson Foundation Clinical Scholar …

PubMed