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One-Third Of New Drugs Had Safety Problems After FDA Approval
Key Excerpts from Article on Website of NPR
Posted: November 29th, 2020
https://www.npr.org/sections/health-shots/2017/05/09/5275750...
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 the medications 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 Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a "black box" warning on side effects or warranted a safety announcement about new risks, Dr. Joseph Ross ... and colleagues reported in JAMA. The Yale researchers' previous studies concluded that the FDA approves drugs faster than its counterpart agency in Europe does 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. "All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective," [Dr. Caleb Alexander] says. "Nothing could be further from the truth. We learn tremendous amounts about a product only once it's on the market and only after use among a broad population."
Note: For more along these lines, see concise summaries of deeply revealing news articles on Big Pharma corruption and health from reliable major media sources.
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