FDA To Recheck Safety of Drug TrialsDec 24, 2004 | Newsday
The Food and Drug Administration yesterday called for an evaluation of all prevention studies involving two controversial painkillers Celebrex and Bextra to ensure adequate protection for participants who use the pills.
At the same time, the FDA issued a public health advisory urging caution by doctors and consumers in prescribing and using pain medications.
A prevention study is a trial in which scientists give medication to healthy people to observe whether it helps prevent certain diseases like colon polyps or Alzheimer's disease.
The FDA's call for a review of studies involving Celebrex and Bextra, which belong to a category of prescription painkillers known as Cox-2 inhibitors, came after recent revelations that such pills may increase the risk of stroke and heart attack, especially when used for long periods of time.
The FDA is calling for institutional review boards groups charged with ensuring scientific studies are ethical and safe to review the prevention trials.
Another pill in the same class of non-steroidal anti-inflammatory drugs, Vioxx, was recently pulled from the market after links to increased heart attacks and strokes.
Dr. John K. Jenkins, the FDA director of new drugs, advised consumers to heed label instructions when using over-the counter painkillers like Aleve, aspirin and Advil. Aleve was recently associated with increased heart problems in a National Institutes of Health study that has been halted.
Jenkins also said: "Physicians prescribing Celebrex or Bextra should consider this emerging information when weighing the benefits against risks for individual patients."
The advisory urged doctors who prescribe the medications to consider individual patients' medical history and risk for cardiovascular events.
The FDA plans to hold a public meeting on problems associated with the painkillers in February.