FDA did not intervene to curb risky fentanyl prescriptions

Documents collected by FDA indicated that a fast-acting class of fentanyl drugs approved only for cancer patients with high opioid tolerance has been prescribed frequently to patients with back pain and migraines, putting them at high risk of accidental overdose and death.

Documents collected by FDA indicated that a fast-acting class of fentanyl drugs approved only for cancer patients with high opioid tolerance has been prescribed frequently to patients with back pain and migraines, putting them at high risk of accidental overdose and death. FDA established a distribution oversight program in 2011 to curb inappropriate use of the dangerous medications, but entrusted enforcement to a group of pharmaceutical companies that make and sell the drugs. Several of the companies have been sued for illegally promoting other uses for the medications. FDA had data showing that off-label prescribing was widespread, but officials did little to intervene. Officials at the agency said they had reviewed evidence indicating that many patients without cancer were given the drugs. However, they said that piecemeal data made it difficult for the agency to measure potential harm to patients. "The information we have isn't very good, but it seems to indicate people who aren't cancer patients are getting this and people who aren't opioid tolerant are getting this," said Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research. "There has been a tremendous back-and-forth with companies on how to get better information," she added.