The Food and Drug Administration knew that some doctors were wrongly prescribing powerful opioid painkillers. The drugs include mouth sprays and lozenges meant to provide immediate relief for breakthrough cancer pain ... in patients who have been taking opioids for long periods of time. The formulations, referred to as transmucosal immediate-release fentanyl products, or TIRF products, can kill patients who take them without having first developed tolerance. But they were prescribed to patients who had no tolerance, and for migraines or dental pain, the team at the Johns Hopkins Bloomberg School of Public Health said. The U.S. is suffering through an epidemic of opioid abuse. Opioids, including prescription opioids and heroin, killed 42,000 people in 2016. At the same time, the CDC reported last year, the number of prescriptions for the painkillers tripled from 1999 to 2015. The FDA set up a special plan to control [TIRF products], called a risk evaluation and mitigation strategy. The FDA asked one of its expert panels ... to help review how the strategy for the TIRF opioids has been working. It has not worked as designed, the Johns Hopkins team said in testimony given to the panel. The strategy has generated red flags for years," the team said in written testimony. "FDA had evidence as early as April 2016 that TIRFs were being prescribed for many patients who were not opioid tolerant," they wrote in their testimony. "Of more than 25,000 patients receiving TIRFs, as many as 51 percent were not opioid tolerant."
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