"The science clearly demonstrates that this is a potentially fatal combination, when opioids and benzodiazepines are prescribed together," said Nicole Alexander-Scott, director of Rhode Island's Department of Health, saying doctors and public health officials have a moral and professional obligation to be transparent about the risks and be cautious when prescribing the drugs to patients.
Opioids, which include narcotic painkillers such as Oxycodone and Hydrocodone, are at the heart of a deadly nationwide epidemic of abuse and addiction. The Centers for Disease Control and Prevention recently reported that overdose deaths from legal opioids grew to nearly 19,000 in the United States in 2014, the most recent year on record. The drugs also have played a role in a surge of overdoses in recent years of heroin, which is cheaper and more widely available than prescription opioids.
At the same time, according to a study last week in the American Journal of Public Health, overdose deaths also have been soaring among Americans who use benzodiazepines, a class of sedatives that includes medications such as Valium and Xanax. Researchers found that the death rate from overdoses involving benzodiazepines -- commonly referred to as "benzos" -- had increased more than four-fold since 1996. In 2013, they noted, deaths from benzodiazepine overdoses accounted for nearly a third of the 23,000 deaths attributed to prescription drug overdoses in the United States.
In Monday's petition, health officials detailed data suggesting that both types of medication become only more risky when used together -- and they are used together frequently. Often, for example, doctors will prescribe opioids to a patient with acute pain, along with a benzodiazepine to treat muscle spasms. Or benzodiazepines for a patient with an anxiety disorder, along with an opioid to treat chronic pain.
"It’s not based on evidence, but it is routine clinical practice," said Baltimore City Health Commissioner Leana Wen. A black box warning, she said, could make doctors more cautious and patients better informed. "Every doctor who is prescribing these drugs now can and should be aware of the risk of fatal overdose."
Experts say the increased risk lies in how the two types of drugs interact. Taken together, they can depress the respiratory system severely, to the point where a patient can stop breathing. That is essentially the message health officials want the FDA to include on labeling for both types of drugs, in a warning that says using both concurrently "reduces the margin of safety for respiratory depression and contributes to the risk of fatal overdose, particularly in the setting of misuse."
"These kinds of black box warnings work. We know they do," said Alexander-Scott, whose state has one of the nation's highest rates for benzodiazepine prescriptions.
The FDA said in a statement Monday it “is committed to working with the health care community and our federal, state and local partners to help reduce opioid and benzodiazepine misuse and abuse. We will continue to monitor the combined use of these products and take necessary actions to ensure prescribers and the public are informed of the risks involved with the use of these medications."