FDA Warns About Co-Use of Opioids and Benzodiazepines

The FDA recently announced stricter guidelines about the use of opioids with benzodiazepines.

These changes will be updated on the drug labels and will help inform providers and patients about associated risks with the combined use of the drugs. The FDA now requires boxed warnings and patient-focused Medication Guides for nearly 400 products, including opioid analgesics, opioid-containing cough products, and benzodiazepines, according to an FDA press release.

Opioid analgesics, such as oxycodone, hydrocodone, and morphine, are included in the warning, along with opioids used to treat cough. Benzodiazepines are typically used to treat neurological and psychological conditions, such as anxiety, insomnia, and seizures.

Both drugs depress the central nervous system and can lead to serious adverse effects, such as extreme sleepiness, respiratory depression, coma, and death, if taken together. Additionally, the FDA issued a Drug Safety Communication regarding the use of the drugs together.

Through this, along with Medication Guides, they provide information for anyone who is taking, or who knows someone taking these medications, and allows them to better understand the associated risks, according to the FDA. This will also allow providers to be cautious about co-prescribing the medications.

New product labeling and increased information came from an FDA data review, which shows that physicians have been co-prescribing the drugs at an increasing rate.

From 2004 to 2011, the rate of emergency department visits from the non-medical use of the drugs increased, and overdose deaths tripled. Patients prescribed an opioid analgesic and benzodiazepine increased 41% between 2002 and 2014, according to the FDA.

These new warnings are a facet of the FDA Opioids Action Plan, which is focused on ending the opioid misuse epidemic, while allowing access to the drugs for pain management. The US Centers for Medicare and Medicaid Services has also taken efforts to curb the overprescribing of opioids alone, and has created several initiatives to do so.

The use of opioids, along with benzodiazepines, was also brought to the attention of the FDA through a citizen petition to change drug labels, although the FDA has already begun working on a scientific review, according to the press release.

“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.”