New Safety Risks Found In 1-In-3 Drugs After FDA Approval

Image courtesy of Joel Zimmer

No one wants patients to have to wait longer for access to potentially lifesaving new drugs, and the newly approved head of the Food and Drug Administration has made it clear that he intends to speed up current approval processes when possible. However, a new study says safety risks were found in around one-third of all new FDA-approved medications after they had been okayed for use by the agency.

The study, released yesterday by the Journal of the American Medical Association Network, looked at the 222 new therapeutic drugs approved by the FDA between 2001 through 2010.

Of those medications, 71 (32%) were flagged for some type of post-market safety event, including three drugs that were pulled from shelves, and 61 new boxed warnings — the most serious type of warning issued by FDA — on drug labels. A number of drugs were responsible for multiple safety events; in total, these 71 drugs accounted for 123 safety events after they were released to the public.

The researchers behind this study point out that, while the FDA requires that drugs be proven both safe and effective, the clinical trials used to demonstrate safety and efficacy may not be using large enough sample sizes or looking at longer-term ramifications of these drugs. Most of these trials, notes the study, use fewer than 1,000 patients and only follow-up with trial subjects for up to six months afterward.

“We seem to have decided as a society that we want drugs reviewed faster,” said Yale professor and lead author of the study Joseph Ross, who calls for putting a “strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively.”

It’s possible that there may be even more safety concerns about FDA-approved drugs after they’ve reached the market, say the researchers. The study includes the caveat that there are safety-related changes that can occur — like labeling changes or discontinuation of certain dosage levels — that were not included in this report. Additionally, given that the median time from approval to first safety even was more than four years, it’s possible that some drugs approved during the time period of the study may still have safety concerns that have yet to be made public.

This study was released on the same day that the Senate approved Scott Gottlieb — a physician and former consultant to pharmaceutical companies — as the new head of the FDA. Gottlieb said during the confirmation process that he believes that certain approval processes can be expedited without risking quality and safety, telling Senators in April, “I think there are ways to modernize clinical studies without sacrificing the gold standard.”

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