Nearly one-third of drugs cleared by the Food and Drug Administration (FDA) pose safety risks that are identified only after their approval, according to a study published May 9 in the Journal of the American Medical Association.
A research team led by Joseph Ross, M.D., M.H.S., associate professor of medicine and public health at Yale University, analyzed data on new drugs approved between 2001 and 2010, with follow up through February 2017.
They found that among the 222 novel therapeutics approved by the FDA (183 pharmaceuticals and 39 biologics), 32 percent were affected by a post-market safety event.
The noted FDA actions included three drug withdrawals, 61 boxed warnings and 59 safety communications to alert physicians and patients that new safety information has been determined.
The three market withdrawals were the arthritis drug Bextra (Pfizer), the irritable bowel syndrome drug Zelnorm (Novartis), and the psoriasis drug Raptiva (Genentech). Bextra and Zelnorm posed cardiovascular risks and Raptiva posed an increased risk of a rare and fatal infection that causes brain damage.
Psychiatric drugs, biologics, drugs that were approved through the FDA’s accelerated approval pathway and drugs that were near the regulatory deadline for approval were more likely to be flagged for a safety issue. The median time for the FDA action was 4.2 years after the drug was approved.
The Yale-led study showed that post-market safety events are common after approval, so continuous monitoring is important throughout the drug’s life cycle.
Monitoring is important because most clinical trials involve fewer than 1,000 patients with a follow-up of six months or less. Safety problems may not appear until years after the drug is introduced to the market—and after a much broader population is using the therapy.
“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 in the post-market period,” Ross noted.
But in an administration that is calling on the FDA to accelerate drug approvals, the study findings highlight the consequences. “It shows that there is the potential for compromising patient safety when drug evaluation is persistently sped up,” said Ross. At the very least, the researchers said the study should inform ongoing debate about premarket drug evaluation.
Filed Under: Drug Discovery