FDA adds toughest warning label to nearly 400 drug products

FDA adds toughest warning label to nearly 400 drug products

Nearly 400 drug products will have to carry new warning labels under a rule change announced Wednesday by the Food and Drug Administration (FDA).

The agency said it's requiring boxed warnings — the FDA’s strongest — on all prescription opioid painkillers, opioid-containing cough medicines and benzodiazepines, also known as benzos, which are prescribed to treat anxiety, insomnia and seizure disorders.

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Under the FDA's new rule, the warnings must include information about the serious risks associated with using the medications at the same time. Possible side effects include extreme sleepiness, respiratory depression, coma and death.

“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 and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines — or CNS depressants more generally — together outweigh these serious risks.”

The FDA said its data show that physicians have been increasingly prescribing powerful pain-reducing medications like oxycodone, hydrocodone, and morphine or opioid medications approved to treat a cough with drugs used to treat anxiety.

The agency found that from 2004 to 2011, the rate of emergency department visits involving nonmedical use of opioids and benzos increased significantly, with overdose deaths from taking prescribed or greater-than-prescribed doses nearly tripling during that period.

Additionally, the number of patients who were prescribed both drugs increased by 41 percent between 2002 and 2014, an increase of more than 2.5 million patients receiving both opioid painkillers and benzos.

- Updated at 3:43 p.m.