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FDA warns against combining opioids and benzodiazepines
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The FDA has issued a warning regarding the combined use of opioids and benzodiazepines, which may result in serious adverse effects such as difficult or slowed breathing and death, according to a press release from the agency.
The agency will add Boxed Warnings, its strongest warning, to the labeling of opioids and benzodiazepines, including oxycodone, hydrocodone, hydrocodone cough syrups, alprazolam, clonazepam, diazepam, and lorazepam, among others. Their actions are consistent with previous clinical guidelines and warnings issued by the CDC.
“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,” Robert Califf, MD, FDA Commissioner, said in a release. “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.”
According to the FDA, the rate of ED visits involving the non-medical use of both drugs increased from 2004 to 2011, and the rate of overdose deaths related to the combination nearly tripled. In addition, there was a 41% increase in the number of patients prescribed both drugs from 2002 to 2014, translating to an increase of more than 2.5 million patients receiving both drugs.
The FDA included specific recommendations for physicians who are prescribing these medications.
"Health care professionals should limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate. If these medicines are prescribed together, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect," the agency stated. "Warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms. Avoid prescribing prescription opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol."