Patient Safety News: One third of drugs approved by FDA pose safety risks

According to a recent article by the Washington Post, nearly a third of drugs approved by the Food and Drug Administration (FDA) are found to have safety risks after approval. A study points out the need for further drug monitoring after the drugs are openly distributed in the market.

“To win FDA approval, medications must be shown to be safe and effective. But many pivotal clinical trials used for approval involve fewer than 1,000 patients with follow-up of six months or less, according to the study. Safety problems often crop up years later after therapies have been used by much larger numbers of patients.”

In the study, the researchers looked at 222 drugs and found that 71 of them (32%) were reviewed by the FDA after approval. Of those 71, 61 required black-box warnings (a label warning of a serious hazard with the drug) and 3 were taken off the market.

Eric Topol of the Scripps Translational Science Institute told the Washington Post that part of the problem is that “clinical trials often cherry-pick patients likely to produce the best results. ‘We don’t get a real-world representation.’”

Attorney Susan Faunce of Berman & Simmons is handling cases relating to complications from dangerous drugs and medical devices.