Nearly a third of FDA-approved drugs had problems, study finds

Among 222 FDA-approved novel therapeutics, there were 123 postmarket safety events. Bextra was among those taken off the market.

Story highlights

  • Seventy-one novel therapeutics approved from 2001 to 2010 had postmarket safety events
  • 3 were withdrawn, 61 got boxed warnings, 59 required safety communications
  • Experts say study shows the benefits of monitoring drug safety

(CNN)Patients might think the US Food and Drug Administration's stamp of approval means that a product is the last word on safety, but about a third of the drugs the FDA approved between 2001 and 2010 were involved in some kind of safety event after reaching the market, according to a study published Tuesday in the Journal of the American Medical Association.

The authors found that in that time, 222 novel therapeutics were approved, and there were 123 postmarket safety events involving 71 products that required FDA action.
    Manufacturers needed to add 61 boxed warnings, also commonly called a black box warning, to call attention to serious or life-threatening risks.
      In 59 cases, some kind of communication had to warn users about a product's safety.
      Three therapeutics were withdrawn from the market.
      Drugs used to treat mental illness and drugs that went through an accelerated approval process had a higher number of "events," the study found.
        "The key message with all new drugs and technology is that there is an ongoing learning process that will continue through the lifetime of the drug," said author Dr. Nicholas S. Downing, an author of the study and a resident physician of internal medicine at Brigham and Women's Hospital in Boston.
        As the study notes, the majority of these drugs were trialed in 1,000 or fewer patients to get FDA approval. When drugs are used under real-world circumstances in a wider patient population, problems can happen, Downing said, and so scientists need to continuously test the drugs to make sure they work with a wide range of variables.
        "Aspirin has been around for hundreds of years. We generally know how it works, for example, but there are still countless new studies coming out, and we learn more about it all the time," he said.
        Although the percentage of safety events may sound high, Downing adds that it is "reassuring" that the system works well enough to catch these problems.