In an effort to prevent overdoses and deaths, the U.S. Food and Drug Administration (FDA) announced on Wednesday tougher warning labels on opioid pain medications and benzodiazepines.
The FDA warned doctors and other clinicians in a safety announcement not to prescribe both drugs to patients simultaneously unless there are no adequate alternative treatments options. The agency said the growing combined use of opioids with benzodiazepines--used to treat anxiety, insomnia and seizures--or other drugs that depress the central nervous system (CNS) has resulted in serious, even fatal, side effects like slowed or difficult breathing.
The FDA has added so-called black box warnings, its strongest warning, to the drug labeling of prescription opioid pain and cough medicines, as well as benzodiazepines. All told, boxed warnings will be required for 389 products, according to a Medscape report.
Warnings about the risk of prescribing opioids and benzodiazepines together are not new. In response to the country’s opioid addiction crisis, the FDA in March beefed up warning labels for a range of prescription painkillers. The latest change places those black box warnings on even more medications.
"When a boxed warning goes out, it alerts all kinds of people who might have missed the message," FDA Commissioner Robert Califf, M.D., said in a news conference, according to Medscape.
The FDA said if doctors have no choice but to prescribe opioids and benzodiazepines together, they should limit the dose and duration of each drug to the minimum needed to treat the patient. Doctors should warn patients and caregivers about the risk for slowed or difficult breathing. They should also avoid prescribing opioid cough medicines for patients taking benzodiazepines or other CNS depressants, which includes alcohol, according to the announcement.