By Jonathan Springston, Associate Managing Editor, AHC Media
The FDA on Wednesday issued a boxed warning to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines in wake of an agency review that found a rise in serious side effects in those who mix benzodiazepines with cough syrup, opioids, or other drugs that depress the central nervous system (CNS).
“We conducted and reviewed several studies showing that serious risks are associated with the combined use of opioids and benzodiazepines, other drugs that depress the CNS, or alcohol,” the agency says. “Based on these data, we are requiring several changes to reflect these risks in the opioid and benzodiazepine labeling.”
The agency advises clinicians to limit prescribing opioids with benzodiazepines and to do so only when alternative treatments are ineffective or not an option. If these strong medications are necessary, the FDA recommends limiting the dosage and duration of treatment while clearly presenting the facts and potential risks. Additionally, the FDA says patients or their caregivers who experience or notice dangerous symptoms, such as dizziness or slowed breathing, while mixing such medications should seek professional help immediately.
“We are continuing to evaluate the evidence regarding combined use of benzodiazepines or other CNS depressants with medication-assisted therapy drugs used to treat opioid addiction and dependence,” the FDA says. “We are also evaluating whether labeling changes are needed for other CNS depressants, and will update the public when more information is available.”
This week, AHC Media launched its new universal premium, The Opioid Epidemic: New Policies, Treatments, and Non-Opioid Alternatives, our exclusive resource providing information you need to know to treat opioid addiction. Next month, ED Management will be dedicated to covering the opioid epidemic with a specific ED focus. Topics include handling repeat ED visitors presenting with addictions, new research into better treatment, alternative therapies, and much more.