FDA: New Warnings for Opioids, Benzodiazepines
The Food and Drug Administration (FDA) announced the addition of Boxed Warnings to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines.
A review of literature has found that the increased combined use of opioids with benzodiazepines or other drugs that depress the central nervous system (CNS) has led to serious side effects, including slowed or difficult breathing as well as deaths. Several studies showed that serious risks were associated with the combined use of opioids and benzodiazepines, other CNS depressants, or alcohol. Based on the data, the FDA is requiring changes to reflect in the Warnings and Precautions, Drug Interactions, and Patient Counseling Information sections of the labeling.
Opioids are narcotic agents used to treat pain and cough, and benzodiazepines are used to treat anxiety, seizures, and insomnia. Opioids carry serious risks of misuse, abuse, addiction, overdose, and death. Some opioids such as codeine and hydrocodone are also approved in combination with other drugs to reduce coughing.
Healthcare professionals should reserve prescribing opioid pain medicines with benzodiazepines or other CNS depressants only for patients whom alternative options are inadequate. If these drugs are prescribed concomitantly, the dosages and duration of each drug should be limited to the minimum possible levels while achieving the desired clinical effect. For example, if a benzodiazepine or other CNS depressant is concomitantly prescribed for an indication other than epilepsy with an opioid analgesic, the benzodiazepine or other CNS depressant should be prescribed at a lower initial dose than indicated in the absence of an opioid; the dose should be titrated based on clinical response.
Healthcare professionals should also warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and related signs and symptoms. Patients should also be screened for risk of substance-use disorders.
Prescription opioid cough medicines should not be prescribed for patients taking benzodiazepines or other CNS depressants, including alcohol. Patients should be advised to not drive or operate heavy machinery until the effects of the concomitant agents have been determined.
The full list of prescription opioid pain and cough medicines and benzodiazepines can be found here. The FDA is continuing to evaluate the data regarding combined use of benzodiazepines or other CNS depressants with medication-assisted therapy (MAT) agents used to treat opioid addiction and dependence. The Agency is also determining whether labeling changes are necessary for other CNS depressants.
For more information visit FDA.gov.