31 Dec 2021 5:19 pm
I suspect you didn't read JAMACannonpointer » 31 Dec 2021, 4:15 pm » wrote: ↑ Here is a study from JAMA about "post market safety events" in the first decade of this century, showing that 32% of new medications, after initially passing muster, were found to present dangers not known to regulators when they were approved: https://jamanetwork.com/journals/jama/f ... le/2625319
Here's an NPR report on the same Yale study referenced above, which reads, "Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a "black box" warning on side effects or warranted a safety announcement about new risks, Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine, and colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28."
https://www.npr.org/sections/health-sho ... a-approval
From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years
In the early stages of biologics there were 3 or fewer withdrawals.