New warnings about serious side effects are required for nearly one-third of new drugs getting the OK; that's according to a new study in the Journal of the American Medical Association.
The Food and Drug Administration is under pressure from the Trump administration to approve drugs faster, but researchers at the Yale School of Medicine found that almost a third of those approved from 2001 through 2010 had major safety issues years after the medications were made widely available to patients. Researchers looked at potential problems that cropped up during routine monitoring that's done once a medicine is on the market.
Fifty-nine drugs, including medication for migraines, erectile dysfunction and diabetes, had safety communications issued for new, serious risks that were identified.
Critics say the study raises questions about how thoroughly drugs are tested. There has been industrywide pressure to reduce review and approval times for drugs and medical devices in order to lower costs. That makes it critically important "that we have a strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively", he said.
"No drug is completely safe, and during premarket evaluation, we are not going to pick up all the safety signals", said Ross. "That's just how it is", Ross said.
Ross, M.D., M.H.S., of the Yale University School of Medicine, New Haven, Conn., and colleagues examined safety events (a composite of withdrawals due to safety concerns, FDA issuance of incremental boxed warnings added in the postmarket period, and FDA issuance of safety communications) for all novel therapeutics approved by the FDA between January 2001 and December 2010 (followed-up through February 2017).
Surprisingly, drugs approved in under 200 days were less likely to have safety issues, which the authors speculate could be because "some approval packages provide clearer evidence of safety, allowing for more rapid regulatory approval".
An agency spokeswoman said that "FDA performs post-market monitoring to identify new safety information that may impact product labeling". The agency said it would review the study findings but declined to comment further. There were also dozens of alerts for less serious potential harms and three drug withdrawals because of the potential for death or other serious harm.
Drugs used to treat mental illness and drugs that went through an accelerated approval process had a higher number of "events", the study found.
Analysis showed that safety events were significantly more frequent among biologics (incidence rate ratio [IIR] = 1.93; 95% CI, 1.06-3.52; P=0.03) and psychiatric disease treatments (IRR = 3.78; 95% CI, 1.77-8.06; P 0.001), as well as treatments with accelerated approval (IRR = 2.20; 95%CI, 1.15-4.21; P=0.02), or near-regulatory deadline approval (IRR = 1.90; 95%CI, 1.19-3.05;P=0.008).
The research team, led by associate professor of medicine and public health Dr. Joseph Ross, found that 32% of new drugs were flagged for a safety issue after approval.
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