- 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
Mia De Graaf For Dailymail.com
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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.
The Yale team analyzed data on new drugs approved between 2001 and 2010, with follow up through 2017. They found 32% of new drugs were flagged for a safety issue after approval
To assess new drugs for safety and effectiveness, regulators rely on drug testing and clinical trials.
But the vast majority of trials involve fewer than 1,000 patients studied over a period of six months or less, making it hard to spot longer term safety issues.
The new study is part of a widespread push to overhaul regulation.
The Yale team analyzed data on new drugs approved between 2001 and 2010, with follow up through 2017.
They found that 32 percent of new drugs were flagged for a safety issue after approval.
‘That is very rarely a drug withdrawal, but more commonly a black box warning, or drug safety communication issued by the FDA to let physicians and patients know that new safety information has been determined,’ said associate professor of medicine and public health Dr Joseph Ross, who led the study.
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The researchers also identified characteristics of drugs that were more likely to be associated with a safety concern, including biologic therapies and drugs that were approved through the FDA’s accelerated approval pathway.
While the study results point to the need for ongoing monitoring of newly approved drugs, they also demonstrate that the FDA’s current process is working.
‘The fact that the FDA is issuing safety communications means it is doing a good job of following newly approved drugs and evaluating their safety up in the post-market period,’ Dr Ross said.
The study findings provide key information about the agency’s process at a time when the FDA is under pressure to accelerate drug approvals.
‘It shows that there is the potential for compromising patient safety when drug evaluation is persistently sped up,’ said Ross.
The researchers hope the study will inform ongoing debate about premarket drug evaluation.
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