U.S. FDA adds new warning about opioid/sedative combination

Aug 31 (Reuters) - The U.S. Food and Drug Administration on Wednesday warned of the danger of combining opioid painkillers and cough medicine with benzodiazepines, a common class of sedatives.

The agency is requiring that black box warnings, the strongest available, be added to some 400 products, alerting doctors and patients that combining opioids and benzodiazepines can cause extreme sleepiness, slowed breathing, coma and death.

The agency said the move is part of a broad action plan to reduce the number of deaths from opioid painkiller abuse.

"It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together," FDA Commissioner Robert Califf said in a statement.

"We implore health care professionals to heed these new warnings," he added.

Opioids include oxycodone, hydrocodone, fentanyl and morphine and are sold under such brand names as OxyContin, Percocet, Vicodin and Actiq. Benzodiazepines include such drugs as alprazolam, clonazepam and lorazepam, sold under the brands Xanax, Klonopin and Ativan.

(Reporting by Toni Clarke in Washington; Editing by Matthew Lewis)

08/31/2016 13:30

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