The U.S. Food and Drug Administration (FDA) recently unveiled class-wide improvements to drug labeling to help patients become more aware of the dangers of combining drugs.
The new labels will include patient information to help physicians and patients be more aware of the serious health risks of combining specific opioid medications and certain central nervous system (CNS) depressant drugs called benzodiazepines.
The specific drugs in question are prescription opioid cough products, opioid analgesics and benzodiazepines. Combining these drugs could lead to serious health risks or even 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 Dr. Robert Califf said. "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 is also mandating boxed warnings – which is the strongest warning from the FDA – as well as patient-focused Medication Guides for opioid-containing cough products, prescription opioid analgesics and benzodiazepines. This will require labeling changes to approximately 400 products.
