As demand grows for faster drug approvals, a new study suggests watching for a concerning side effect: medicines that were approved using expedited regulatory procedures had a 38 percent higher rate of changes to safety warnings on product labels.
The analysis also found that there was a 48 percent higher rate of changes to the two most important types of warnings — so-called black boxes, which are designed to call attention to serious or life-threatening risk, and contraindications, which refers to a risk outweighing a benefit.
The findings suggest that drugs approved through expedited pathways — accelerated approval, priority review, and fast track — need additional monitoring, according to the Harvard Medical School researchers who conducted the study, which was published in BMJ. The authors also say these approaches should not overused. And they pointed to a new law called the 21st Century Cures Act, which was backed by the pharmaceutical industry and many patient advocacy groups, that is expected to accelerate such approvals.
While it would seem to be a contradiction, I wonder how much input into the label changes came from ‘off-label use.’ Such certainly happens and causes problems that add to the knowledge base.
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