1 In 3 FDA-Approved Drugs ‘Are Flagged For Safety Errors’

  • A Yale team analyzed drugs approved from 2001-2010, and followed up to 2017
  • They found 32% of these drugs were flagged for safety issues within years

A third of drugs approved by the Food and Drug Administration are flagged for safety concerns in the years after, a Yale-led study warns.

Researchers analyzed 222 newly-approved drugs since 2001, and found 72 of them (32 percent) required new warnings to be printed on their label.

On average, it took 4.2 years for these concerns to come to light after approval.

Most of the issues are not serious enough to withdraw the drug from the market.

However, experts warn the finding highlights a serious gap in how the regulation industry handles the transition of drugs from experimental to wide-spread….continue reading


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