Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a “black box” warning on side effects or warranted a safety announcement about new risks, Dr.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.
It took a median of 4.2 years after the drugs were approved for these safety concerns to come to light, the study found, and issues were more common among psychiatric drugs, biologic drugs, drugs that were granted “accelerated approval” and drugs that were approved near the regulatory deadline for approval.
NPR
And that article was published in 2017 when FDA still had a process for mandatory trials and research to approve any new drug or treatment to the market.
Do you think now it’s at least as “good”?
Can we even say it’s “good” to have a 3rd of drugs come out with safety problems?
Can we not learn from the OxyContin fiasco?
How much trust can be put into the safety of new treatments?