The U.S. Food and Drug Administration (FDA) is intensifying its anti-drug abuse campaign by requiring drug makers to add warning labels on their products about the dangers of mixing anti-anxiety medications with opioids.
The drug safety agency announced on Wednesday, Aug. 31, that it has ordered nearly 400 benzodiazepine products to carry "black box warnings" that inform consumers about the health risks involved in using the drugs with opioid medications.
The FDA said the drug combination has been found to produce severe adverse effects in users such as difficulty in breathing, coma or even death.
Aside from benzodiazepines, the new order also includes other drug products that depress the normal function of the central nervous system such as antipsychotic drugs, insomnia medications, muscle relaxants and alcohol.
Cough syrups made using the opioid codeine should also carry the government warnings.
Doctors are advised to take extra care when prescribing treatment plans that combine benzodiazepines with opioid drugs. They should also inform their patients that using medications can result in slowed breathing, dizziness, extreme sleepiness and unresponsiveness.
The new order comes after the FDA discovered through an extensive review of scientific evidence that doctors have been increasingly prescribing the use of the dangerous drug combination to their patients.
The agency also received a petition from city and state health officials in February to change the drug labels after an increase in overdose cases involving the simultaneous use of anti-anxiety drugs and opioid medications.
According to the FDA, the number of people who were prescribed to use both benzodiazepines and opioid analgesics increased by as much as 41 percent from 2002 to 2014, resulting in an additional 2.5 million Americans taking the dangerous drug combination.
The agency also recorded a significant increase in the number of emergency hospital visits involving the nonmedical use of benzodiazepines and opioid analgesics from 2004 to 2011. Overdose deaths related to the abusive use of the drugs also rose during that period.
"It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together," FDA commissioner Dr. Robert Califf said.
Baltimore City Health Commissioner Dr. Leana Wen welcomed the FDA's order to add black box warning labels on the drug products. She said the labels provide an educational tool that can help prevent deaths involving the use of the drug combination.
The FDA said it is continuing its research on the safety of using both benzodiazepines and opioid medications in drug-assisted therapies.
