Nearly a Third of Drugs Hit by Safety Issues After FDA Approval

Researchers examined data on drugs approved by the FDA between 2001 and 2010, with follow-up through 2017. The investigators found that 32% of the drugs had safety issues 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 study leader Dr. Joseph Ross. He is an associated professor of medicine and public health at Yale University.

Of 222 drugs approved by the agency during the study period, three were withdrawn, 61 received boxed warnings and 59 prompted safety communications, the findings showed.

Drugs most likely to have post-approval safety concerns included biologics, psychiatric drugs and medicines approved through the FDA’s accelerated approval process. The report is timely because the FDA is under pressure to accelerate drug approvals, the study authors noted.

“It shows that there is the potential for compromising patient safety when drug evaluation is persistently sped up.” Ross said in a university news release.

To assess experimental drugs for safety and effectiveness, the FDA relies on pre-market drug testing and clinical trials. Most of the trials involve fewer than 1,000 patients studied over a period of six months or less. This makes it hard to detect safety issues that might surface once more patients use the drug over a longer time period, the researchers explained.