Years after being released to the public, a third of unique drugs glean flagged for added safety concerns by the Food and Drug Administration, a unique study published Tuesday in the journal JAMA has revealed. And many tend to be drugs that were rushed through the approval process.
As of 2015, the study authors found, the FDA had alerted the public 123 times approximately unique health risks surrounding drugs that had been approved from 2001 to 2010. The alerts came in the form of black box warnings, which update a drug’s label to include serious, potentially life-threatening side-effects, milder safety communications, or a full withdrawal of the drug from the market. total told, 68 out of 222 unique drugs had received some sort of unique warning, and three drugs were pulled off the shelves entirely.
“Postmarket safety events are common after FDA approval,” the authors wrote, “highlighting the importance of continual monitoring of the safety of novel therapeutics throughout their life cycle.”
Looking deeper, the authors found that certain classes of drugs were more likely to glean rung up for unique health risks, like psychiatric medications. But the way they had gotten through the approval process also seemed to matter. Drugs allowed to get a faster review of their application or that had been approved within 60 days of a mandated dateline were more likely to be pleased undetected issues.
The are several reasons why this may be happening, the authors wrote. Accelerated approvals may lead to regulators to miss things in uncovering every potential side-effect. Meanwhile, drugs approved at the final minute are already more likely to be riskier than drugs that went through an easy, quick approval. But the pressure to not turn down a drug at the final moment may be pleased led to regulators dropping the ball.
Of course, even in the best of circumstances, there are going to be missed risks. Only a small number of patients purchase any given unique drug before it’s approved. And some risks may not elaborate up until years of long-term consume or only with certain groups of people, like pregnant women.
But coupled with other research showing a similar effect, it seems obvious the more quickly drugs are approved, the more likely we are to miss potential problems with them.
That’s a reality particularly relevant with the recently passed 21st Century Cures Act final winter, which will provide funding to the FDA over the next ten years to speed up the drug approval process, among other provisions. The presumptive next person to head the FDA under President Trump, nominee Scott Gottlieb, has also made clear his desire to attain the same — likely by doing absent with certain regulations.
Currently, the FDA already has a drug review pipeline that’s quicker than that of its European counterpart, the European Medicine Agency. But unlike the FDA, the EMA’s track record of post-market safety alerts doesn’t seem to be affected by how quickly approvals are made — a 2015 study found that neither accelerated drugs nor drugs approved near the deadline were more likely to be pleased added safety risks following their release.