FDA requiring changes to drug labeling

After an extensive review of the latest scientific evidence, FDA announced Wednesday that it is requiring class-wide changes to drug labeling, 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 a class of central nervous system (CNS

After an extensive review of the latest scientific evidence, FDA announced Wednesday that it is requiring class-wide changes to drug labeling, 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 a class of central nervous system (CNS) depressant drugs called benzodiazepines. Among the changes, FDA is requiring boxed warnings and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines, with information about the serious risks associated with using these medications at the same time. Risks 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," said FDA Commissioner Robert Califf, MD. "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."