In a recent announcement by the FDA, boxed warning labels will now be required to advise against the utilization of prescription opioid pain medicines alongside benzodiazepines unless no other adequate alternative treatment method exists. Warnings about the risks of combining these two classes of drugs are nothing new. Already required on drug warning labels, additional black box warnings are an effort by the FDA to reach out to those who may have “missed the message.”
Classified as Central Nervous System (CNS) depressants, each drug alone can trigger side effects such as respiratory depression (slowed/labored breathing), coma, and death, the effects of which are enhanced in combination. For clinicians living in the dark, these risks will now be spelled out in the black boxes of 389 different pharmaceuticals. Additionally, opioid painkillers such as oxycodone and benzos like alprazolam (i.e. Xanax®) – even the combination of opioid cough medicines with benzos and other CNS depressants (like alcohol) should be avoided. If the drugs must be used together, clinicians have been advised to warn patients of these risks.
The FDA’s latest measure in battling the nationwide epidemic of prescription opioid abuse, essentially classifies this drug combination in the “last resort” genre. Rates of emergency room visits resulting from the nonmedical use of this combination of drugs has tripled from 2004-2011, with the rates of drug-related deaths following suit. According to the FDA, these rates coincide with a 41% increase in patients prescribed both an opioid and benzo between years 2002-2014. The measure is a win for public health officials from 17 states and territories and 13 cities who petitioned the agency in February to require the boxed warning in an effort to fight the routine but unproven treatment method.
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