With the growing use of opioid medicines taken with benzodiazepines resulting in serious side effects and deaths, the Food and Drug Administration (FDA) is requiring boxed warnings — the strongest type of warning — on the drug labeling of prescription opioid pain and prescription opioid cough medicines, as well as on benzodiazepines.
The warning comes after the FDA conducted and reviewed several studies showing serious risks, including breathing difficulties and death, associated with the combined use of opioids and benzodiazepines or other central nervous system (CNS) depressants or alcohol. Based on the data, the FDA is requiring changes that include the new boxed warnings and revisions to the warnings and precautions, drug interactions, and patient counseling sections of the labels.
Health care professionals are advised to limit prescribing of opioid pain medicines with benzodiazepines or other CNS depressants “only to patients for whom alternative treatment options are inadequate,” according to an Aug. 31 FDA safety communication.
If the medicines are prescribed together, the dosages and duration of each drug should be limited to the minimum needed to achieve the desired clinical effect. Patients and caregivers should be warned about risks of slowed or difficult breathing and/or sedation, along with the associated signs and symptoms such as unusual dizziness or lightheadedness, extreme sleepiness, or unresponsiveness.
Parents also should be reminded to lock up opioids and benzodiazepines and to dispose of them properly to keep them from being taken accidentally by children or falling into the wrong hands.
In addition, physicians should avoid prescribing opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol.
The FDA is continuing to evaluate the evidence on combined use of benzodiazepines and other CNS depressants with medication-assisted therapy drugs used to treat opioid addiction and dependence.
Health care professionals and consumers are encouraged to report adverse events or side effects related to use of these products to the FDA. Call 1-800-332-1088 to request a form, or submit the report online at www.fda.gov/MedWatch/report.
For more information, read the FDA MedWatch safety alert at http://bit.ly/2cruDye.
