F.D.A. Did Not Intervene to Curb Risky Fentanyl Prescriptions
Emily Baumgaertner
The New York Times
August 2nd, 2018
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Emily Baumgaertner
The New York Times
August 2nd, 2018
WASHINGTON - 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, according to documents collected by the Food and Drug Administration.
The F.D.A. 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.
Some of the companies have been sued for illegally promoting other uses for the medications and in one case even bribing doctors to prescribe higher doses.
About 5,000 pages of documents, obtained by researchers at the Johns Hopkins Bloomberg School of Public Health through the Freedom of Information Act and provided to The New York Times, show that the F.D.A. had data showing that so-called off-label prescribing was widespread. But officials did little to intervene.
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The class of drugs - quick-absorbing fentanyl sprays, tablets and lozenges called T.I.R.F.s (for transmucosal immediate-release fentanyl) - contain a narcotic up to 50 times stronger than heroin and up to 100 times stronger than morphine. Examples include Actiq and Fentora, made by Cephalon, and Subsys, made by Insys Therapeutics.
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