"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
#RaviGupta #drugs #pharma #DrugShortage
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
#icu #drugs #UnapprovedByFDA #RaviGupta #JoeRoss #wtf #atropine #epinephrine #hydrocodone #levothyroxine #morphine #nitroglycerine #oxycodone #pancrelipase #phenylephrine #vasopressin #MedMastodon
#RaviGupta pointing out there is a #DrugShortage #Database
"U.S. Drug Shortages
We used the University of Utah’s Drug Information Service drug shortage database from January 1, 2004, to December 31, 2015. A shortage is defined as a supply issue that affects how a pharmacy prepares or dispenses a drug product that influences patient care when prescribers must use an alternative agent.26...
#RaviGupta #DrugShortage #database
ok, more #JohnsHopkins #RaviGupta on #DrugInsanity #pharma
"The FDA estimated that approximately 2% of all prescriptions dispensed in the United States in 2006 may have been for drug products lacking FDA approval"
https://pubmed.ncbi.nlm.nih.gov/28944731/
Including things like #hydrocodone and #SublingualNitroglycerine
Where's #Twitterx #Pharmastodon at?
#JohnsHopkins #RaviGupta #DrugInsanity #pharma #hydrocodone #SublingualNitroglycerine #TwitteRx #pharmastodon
Reading my new #JohnsHopkins colleague #RaviGupta's paper on new drug formulations in #JAMAHealthForum
https://pubmed.ncbi.nlm.nih.gov/35977259/
Levels of devious #pharma and clever data
Devious + #NewToMe: #Evergreening #ProductHopping
Super Cool #data: #DrugInnovativeness and #Prescrire
#JohnsHopkins #RaviGupta #JAMAHealthForum #pharma #NewToMe #Evergreening #ProductHopping #data #DrugInnovativeness #Prescrire