September 01, 2016
Area(s) of Interest: Drug Prescribing/Dispensing Patient Care Public Health
The Food and Drug Administration (FDA) announced last week it will require tough new warning labels that spell out the increased risks of combining anti-anxiety (benzodiazepines) with prescription opioids.
Nearly 400 opioid products will now be required to carry "boxed warnings" – the FDA’s strongest warning – that highlight the risks from combined use, which include extreme sleepiness, respiratory depression, coma and death.
The new warning labels are one of a number of steps the FDA is taking as part of the agency’s Opioids Action Plan, which focuses on policies aimed at reducing prescription opioid misuse, abuse and overdose, while still providing patients in pain access to effective and appropriate pain management.
The FDA is also urging physicians to be extra careful when prescribing medication regimens that mix the two classes of drugs, and prescribe opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options have been ineffective.
“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 [central nervous system] depressants more generally – together outweigh these serious risks," said FDA Commissioner Robert Califf, M.D.
According to the FDA, if these medicines are prescribed together, physicians should limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. Physicians should also warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms.
Click here to see the drug and safety communication from the FDA.