Following a review of the evidence, the US Food and Drug Administration (FDA) has announced that it is requiring class-wide changes to drug labelling, including patient information, to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and benzodiazepines.
Among the changes, the FDA is requiring boxed warnings, (the FDA's strongest warning) and new patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines.
Nearly 400 products are affected and must include information about the serious risks associated with using these medications.
Risks identified by the FDA include extreme sleepiness, respiratory depression, coma and death.
The labelling changes are part of the agency's Opioids Action Plan, which "focuses on policies aimed at reversing the prescription opioid abuse epidemic, while still providing patients in pain access to effective and appropriate pain management".
"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," said FDA commissioner Robert Califf.
"We implore health 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," Califf added.
The FDA has conducted a data review which showed doctors have increasingly been prescribing these types of medications together, which has been associated with adverse outcomes.
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