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August 13, 2014
What's Safer: Newly Approved Drugs or Older Drugs? 

Boston—A new study poses an intriguing question about what’s safer: a newly approved drug or one that has been on the market a while.

It also provides an answer: Newer drugs have a one in three chance of acquiring a black box warning or being withdrawn for safety reasons within 25 years of their approval.

The study, led by researchers from Cambridge Health Alliance /Harvard Medical School, was published recently in Health Affairs. The research included all drugs approved by the FDA over a 35-year period.

The study compared warning and withdrawal rates for drugs released before and after 1992 when the Prescription Drug User Fee Act (PDUFA) first allowed the FDA to collect fees to expedite drug approvals. As a result of PDUFA, which went into effect at the urging of the pharmaceutical industry, the average drug approval time for all drugs has fallen from 34 months to 16 months.

Results indicate that 26.7% of post-PDUFA drugs were withdrawn or received the highest level warning compared to 21.2% pre-PDUFA, which underwent longer approval processes.

Study authors posit that the expedited process may have led to the release of drugs before they could be adequately evaluated for safety issues.

“The FDA is under constant pressure to rush new drugs through the pipeline to approval. In its hurry, the FDA is apparently failing to distinguish useful drugs from toxic ones, and more dangerous drugs are slipping through,” said lead author Cassie Frank, MD, a physician at Cambridge Health Alliance and an instructor in medicine at Harvard Medical School. “By the time many drugs receive serious safety warnings, millions of Americans have already been exposed to their side effects, which can sometimes be fatal.”

“Our findings raise concern that the FDA is rushing its review of new drugs and allowing potentially unsafe medicines onto the market. As a primary care doctor, I'm wary of prescribing brand new drugs unless they're really a breakthrough, since their full risks are often unknown. And patients should be wary too,” added senior author Karen Lasser, MD, MPH, associate professor of medicine at BUSM who practices internal medicine at BMC.

The study points out that half of all black box warnings were added after a drug had been on the market for 12 years, with safety withdrawals sometimes occurring as long as 30 years after a drug’s initial release, according to the report.

While very few of the 32 drugs withdrawn for safety reasons had clearly unique benefits at the time of their approval, according to the report, all had unique risks that eventually led to their withdrawal.



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