Can a Label Really Stop the Abuse of Some Prescription Meds?


Concerns over the risks of combining benzodiazepine and opioid prescriptions has 41 state health officials petitioning the Food and Drug Administration (FDA) to place a new black box warning on both drugs’ labels to warn patients and doctors of the potential risks with long-term use.

Do We Need Another Warning Label?

The petition comes on the heels of a recently published six-year study of US veterans analyzing the relationship between history of benzodiazepine prescription and the associated risk of death from a drug overdose, found that the risk of death from drug overdose significantly increased in a synergistic, dose-response fashion as daily benzodiazepine dose increased.

Officials are also calling for the FDA to require medication guides for both classes of medications that specifically warn patients of the potential dangers of combined use of opioids and benzos, since their combined daily use has increased.

The Little Black Box

FDA guidance says a black box warning is appropriate when:

There is an adverse reaction so serious in proportion to the potential benefit from the drug (e.g., a fatal, life-threatening, or permanently disabling adverse reaction) that it is essential that it be considered in assessing the risks and benefits of using the drug;” OR “There is a serious adverse reaction that can be prevented or reduced in severity by appropriate use of the drug (e.g., patient selection, careful monitoring, avoiding certain concomitant therapy, addition of another drug or managing patients in a specific manner, avoiding use in a specific clinical situation).”

The state health officials said both of these conditions for a black box warning are met in this case and believe incorporating such a warning will make both clinicians and patients generally aware of the dangers.

Will it Make a Difference?

At a time when consumers want everything right now, are they really even likely to stop and read the label? Experts say yes. However, the problem isn’t reading prescription labels, per se, it’s understanding them.

A 2004 report from the Institute of Medicine estimated that 90 million Americans have trouble understanding health care information, while a 2006 study published in the Journal of General Internal Medicine found that the written instructions and illustrated warnings on medications have a tendency to confuse patients. This is troublesome, as most patients rely on their own ability to follow the label instructions found on pill bottles.

Taking all this information into consideration, having an unambiguous black box warning sign should be more effective at providing a clear-cut message and helping to reduce the preventable medication errors sustained each year.

Additional Reading: Are Benzos Overprescribed?

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