On August 31, 2016, the U.S. Food and Drug Administration announced new class-wide labeling changes for certain drugs. These changes include on-package patient information, aimed at helping health care workers and patients alike avoid serious health risks and possible death from the combination of certain medications.
Called the Opioids Action Plan, the FDA will now require boxed warnings –it’s strongest warning label- in an effort to prevent the potentially lethal mixture of various opioid medications with a class of central nervous system (CNS) depressant drugs known as benzodiazepines. Further, patient-focused Medication Guides will also be a requirement for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines. Provided in these medication guides will be information about underlining serious risks that can arise when these medications are used together. These medication guides will be required for around 400 different medications in total. The risks of combining these medications range from extreme sleepiness, reparatory depression, coma and even death.
FDA Commissioner Robert Califf, M.D. did not hold back when describing the importance of the new label requirements, “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. 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 Opioids Action Plan was prompted by multiple factors, including an FDA data review that revealed a concerning increase in physicians who were prescribing benzodiazepines and opioids together with sometimes tragic outcomes. Simultaneously, the public has been raising alarms of this health crisis. In February of this year a citizen petition was sent to the FDA from multiple state and local public health officials demanding that the agency take stronger measures when it comes to labeling benzodiazepines and opioid analgesics.
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