FDA says harm of untreated opioid addiction outweighs risks of concomitant benzodiazepine use

October 02, 2017
Area(s) of Interest: Drug Prescribing/Dispensing Public Health Patient Care 

Medication-assisted treatment (MAT) for opioid addiction is an important tool that has the potential to help millions of Americans with an opioid use disorder. In fact, patients receiving MAT cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration. However, health care providers and patients face significant challenges when determining how best to treat opioid use disorder, especially when the MAT drugs contain methadone or buprenorphine – which are also opioids.

The U.S. Food and Drug Administration (FDA) recently issued a statement saying that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). However, the agency is requiring changes to MAT drug labels to help decrease the risks of combining these drugs.

The new labeling recommends that health care providers develop a treatment plan that closely monitors any concomitant use of these drugs, and carefully taper the use of benzodiazepines, while considering other treatment options to address mental health conditions that the benzodiazepines might have been initially prescribed to address.

The FDA’s Drug Safety Communication recommends that health care providers take steps such as:

  • Educating patients about the serious risks of combined use, including overdose and death, that can occur with CNS depressants even when used as prescribed, as well as when used illicitly.

  • Developing strategies to manage the use of prescribed or illicit benzodiazepines or other CNS depressants when starting MAT.

  • Tapering the benzodiazepine or CNS depressant to discontinuation if possible.

  • Verifying the diagnosis if a patient is receiving prescribed benzodiazepines or other CNS depressants for anxiety or insomnia, and considering other treatment options for these conditions.

  • Recognizing that patients may require MAT medications indefinitely and that their use should continue as long as patients are benefiting and their use contributes to the intended treatment goals.

  • Coordinating care to ensure other prescribers are aware of the patient’s buprenorphine or methadone treatment.

  • Monitoring for illicit drug use, including urine or blood screening.

Patients taking MAT drugs should continue to take these medicines as prescribed, and should stop taking other prescribed medicines without first talking to their health care professional.

Physicians are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program, available online at www.fda.gov/MedWatch/report. You can also call (800) 332-1088 to request a paper reporting form.

For more information about opioid safety, see the California Medical Association's safe prescribing resource page at Safe Prescribing.


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