FDA warns of fatal risks from mixing opioids and sedatives

The FDA on Wednesday stopped short of requiring a new black box warning on drugs such as methadone used to wean people addicted to opioids from those drugs.

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. Several studies showed that serious risks were associated with the combined use of opioids and benzodiazepines, other CNS depressants, or alcohol. The combination can lead to extreme sleepiness; but more than that, it can also cause breathing problems, coma, and even death.

And from 2004 to 2011, the rate of emergency department visits involving nonmedical use of both drug classes increased significantly, with overdose deaths involving both drug classes almost tripling during that period, FDA found.

"Health care professionals should limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate".

Opioids are narcotic agents used to treat pain and cough, and benzodiazepines are used to treat anxiety, seizures, and insomnia. Between 2004 and 2011, the number of deaths attributed to overdoses from taking the recommended dosage in combination with another drug has almost tripled.

The revised labeling will differ depending on the unique pharmacology, safety risks, and labeling information of each drug class. The benzodiazepines that will get the warning are sold under a variety of brand and generic names, including Xanax, Valium and lorazepam.

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The agency is taking the action because, from 2002 to 2014, there has been a 41 percent increase in prescriptions of both drugs to single patients, equating to about 2.5 million more people potentially at risk for side effects or death.

The Centers for Disease Control and Prevention warned doctors in the spring against prescribing opioids with benzodiazepines, except for patients battling diseases, such as cancer.

The federal announcement followed a petition from health directors in 16 states and 12 cities filed in February.

The move appears after an extended review of scientific proof by the FDA pointed out that doctors have been frequently prescribing these medications together.

"If a patient was in a vehicle accident and experiencing neck pain, a clinician might prescribe opioids for the pain and benzodiazepines for muscle spasms", she said. Patients and caregivers should be warned about risks of slowed or hard breathing and/or sedation, along with the associated signs and symptoms such as unusual dizziness or lightheadedness, extreme sleepiness, or unresponsiveness.


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