President Trump wants the Food and Drug Administration to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of medications that reached the market from 2001 through 2010 had major safety issues years after they became widely available to patients.
Seventy-one of these 222 drugs were withdrawn, required a “black box” warning about serious side effects, or warranted a safety announcement about new risks to the public, Yale professor Dr. Joseph Ross and his colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28.
“While the administration pushes for less regulation and faster approvals, those decisions have consequences,” Ross said. The Yale researchers’ previous studies concluded that the FDA approves drugs faster than its counterpart agency in Europe, and that the majority of pivotal trials used in drug approvals involved fewer than 1,000 patients and lasted six months or less.
You are trying to change a single chemical reaction inside a person where over a billion unique reactions occur. I’m surprised only 1/3 of new drugs have safety concerns. At the end of the day you can’t determine the longterm effects of drugs or even see rarer side effects with small control groups. Drugs should be approved faster and better records should be kept to spot these problems early.
New drugs are a shot in the dark, years of FDA study doesn’t increase safety, it merely slows down progress.
Wow! To say the least? I take many ssri’s and an atypical anticycotic. For depression anxiety and OCD. Now im going to do more reaserch but this is very unsettling. I dont want to die early because of a med. But I still know the benifbenefits these drugs have given me. A big dilemma. It seems like alot of government agency’s are not doing a good job these days? I just wish that they could have cot these negative side effects sooner before releasing then to the public. There’s already enough negative side effects to begin with. Now you have more side effects to look forword to. Thanks FDA?!
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