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pnwmom

(108,955 posts)
Tue May 9, 2017, 05:09 PM May 2017

Multi-year study: 1/3 of new drugs had major safety problems after general release.

This is why it's better not to take drugs in their first years after FDA approval: not all the problems are revealed in controlled studies. The general public also become guinea pigs in those first years; it took a median of over 4 years for the problems to come to light. So half weren't revealed till more than 4 years after approval.

http://www.npr.org/sections/health-shots/2017/05/09/527575055/one-third-of-new-drugs-had-safety-problems-after-fda-approval

The Food and Drug Administration is under pressure from the Trump administration to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of those approved from 2001 through 2010 had major safety issues years after they were made widely available to patients.

Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a "black box" warning on side effects or warranted a safety announcement about new risks to the public, Dr.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.

"While the administration pushes for less regulation and faster approvals, those decisions have consequences," Ross says. 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 in drug approvals involved fewer than 1,000 patients and lasted six months or less.

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.

SNIP

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Multi-year study: 1/3 of new drugs had major safety problems after general release. (Original Post) pnwmom May 2017 OP
Disregard all commercials for drugs you have never heard of dalton99a May 2017 #1
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