Safety of new drugs questioned by researchers

Dr Frank

Physicians and patients should avoid new drugs unless they are truly breakthrough drugs, according to a study in Health Affairs.

“FDA needs to make sure drugs are safe before they're approved and not rush to judgment in order to meet artificial deadlines,” according to the lead author Cassie Frank, MD, a physician at Cambridge Health Alliance, and an instructor in medicine at Harvard Medical School.

“We were concerned about the increased number of high-profile drugs that were withdrawn or received warnings, such as rosiglitazone [Avandia] and rofecoxib [Vioxx], that appeared to follow in the wake of the Prescription Drug User Fee Act [PDUFA],” said Karen Lasser, MD, MPH, an associate professor of medicine at Boston University School of Medicine and a physician at Boston Medical Center.

Since the law was enacted, average drug approval time for all drugs has gone from 34 months to 16 months.

Here are the latest FDA drug approvals

“We wanted to know if there was a significant difference in the rate of safety-based warnings and withdrawals since PDUFA was passed,” Dr Frank said.

The researchers identified all of the drugs that were pulled off the market or received a serious new safety warning after they were approved by FDA. Then they looked at whether these safety problems have gotten more frequent since the passage of the 1992 PDUFA law “that pressured FDA to speed up drug approvals,” according to the researchers. 
Overall, new drugs have a 1-in-3 chance of getting the most serious safety warning-black-box warning-or being completely banned from the market.

“This often happens years after the drug has been on the market,” Dr Frank said. “In other words, patients may be unknowingly exposed to life-threatening side effects for years. The most disturbing thing we found is that these serious safety problems have increased since 1992, when [PDUFA] put FDA under pressure to hurry up its drug approvals. Our findings mean that FDA is letting an increasing number of dangerous drugs on to the market.”

This study has immense implications for clinical practice, according to Dr Frank.

“For many common conditions such as diabetes, hypertension, and depression, we already have a great armamentarium of tried and true medications,” she said. “We know what side effects and adverse reactions to anticipate, and we know which drugs are most effective. Avoiding new drugs will keep patients safer and help contain costs at the same time.”