FDA urged to add black-box warning labels about deadly risk of mixing opioids with benzodiazepines

FDA urged to add black-box warning labels about deadly risk of mixing opioids with benzodiazepines

A few weeks ago we reported about new research showing that combining opioids with benzodiazepines carries a 4-times-higher risk of fatal overdose. Now we read in the Washington Post that “dozens of public health officials and academics across the country are pushing the Food and Drug Administration (FDA) to warn people about the potential dangers of taking powerful prescription painkillers alongside common anti-anxiety drugs known as benzodiazepines.” The paper says 41 officials from various state and municipal health departments and universities have submitted a petition to the FDA. They are urging the agency to add “black box warnings” to the labels of all opioids and benzos. A “black box warning” is popular slang for what the FDA simply calls a “Boxed Warning.” It’s the strictest warning the FDA can add to the labeling of any prescription drug. It’s “designed to call attention to serious or life-threatening risks,” the FDA says. Typical prescription opioids include oxycodone, hydrocodone, morphine, methadone and many others. Popular trade names include OxyContin, Percodan, Percocet, Vicodin and many others. Widely prescribed benzodiazepines include such antianxiety drugs as diazepam (Valium), alprazolam (Xanax), clonazepam (Klonopin) and lorazepam (Ativan). There are dozens more.

Moral and professional obligation

The petition explained that prescribing habits of American doctors show how doctors often prescribe opioids with benzodiazepines. They might prescribe opioids to treat acute pain, and also prescribe a benzo to treat muscle spasms. Or they might prescribe a benzo for an anxiety disorder along with an opioid to treat chronic pain. The director of Rhode Island’s Department of Health, Nicole Alexander-Scott, said that 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.” She said the science clearly demonstrates that prescribing opioids and benzodiazepines together is a potentially fatal risk. Baltimore City Health Commissioner Leana Wen said that a black box warning would help make doctors more cautious and also help patients be better informed. “Every doctor who is prescribing these drugs now can and should be aware of the risk of fatal overdose,” she added. The research showing the four-times-greater risk of overdose, published in the British Medical Journal, said that the high risk of overdose is still present, even when both the opioids and the benzos are at a relatively normal dose. When you factor in the usually higher doses taken by drug addicts and abusers, the risk of fatal overdose soars far higher than the four-times factor. In fact, fatal combinations of opioids and benzos are statistically near the top among heroin and prescription painkiller addicts.

Central nervous system depressants

The problem is that both drugs are “central nervous system (CNS) depressants” – either one of them can cause the breathing and heart rate to perilously slow down. Many people, including ordinary medical patients, are more sensitive or susceptible than others to these effects. So just taking the two drugs “as prescribed” can still cause an overdose. It should be noted that as well as opioids and benzodiazepines, there are two other frequently abused CNS depressants: alcohol and barbiturates. All four of these drugs can kill you all by themselves. They are more dangerous in any combination. And the risk soars each time you add one more to the mix. The message that health officials want the FDA to include on the labeling of both types of drugs, the Washington Post said, should say that using both drugs at the same time “reduces the margin of safety for respiratory depression and contributes to the risk of fatal overdose, particularly in the setting of misuse.” Here at Novus, we heartily endorse bigger and louder warnings to avoid drugs of all kinds when at all possible. Our job is to help people leave drugs behind for good and get their lives back. If you need help with a drug or alcohol problem, or know someone who does, don’t hesitate – call us now.

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