New Safety Risks Surface For 1 In 3 New Drugs After Clearing FDA

It's a problem that could get worse in the Trump era, as regulators seek to speed up approvals

Photo Illustration: Diana Quach
May 09, 2017 at 1:37 PM ET

Years after being released to the public, a third of new drugs get flagged for added safety concerns by the Food and Drug Administration, a new 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 about new 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. All told, 68 out of 222 new drugs had received some sort of new 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 continuous 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 get rung up for new health risks, like psychiatric medications. But the way they had gotten through the approval process also seemed to matter. Drugs allowed to receive a faster review of their application or that had been approved within 60 days of a mandated dateline were more likely to have undetected issues.

There 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 last 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 last second may have 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 take any given new drug before it’s approved. And some risks may not show up until years of long-term use or only with certain groups of people, like pregnant women.

But coupled with other research showing a similar effect, it seems apparent the more quickly drugs are approved, the more likely we are to miss potential problems with them.

That’s a reality especially relevant with the recently passed 21st Century Cures Act last 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 do the same — likely by doing away 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 fast approvals are made — a 2015 study found that neither accelerated drugs nor drugs approved near the deadline were more likely to have added safety risks following their release.