FDA Urges Caution About Withholding Opioid Addiction Meds From Patients on Benzodiazepines

September 20, 2017

ROCKVILLE, Md -- September 20, 2017 -- Based on an additional review, the US Food and Drug Administration (FDA) is advising 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).

The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks. Careful medication management by healthcare professionals can reduce these risks.

The FDA is requiring this information to be added to the buprenorphine and methadone drug labels along with detailed recommendations for minimising the use of medication-assisted treatment (MAT) drugs and benzodiazepines together.

Many patients with opioid dependence may also use benzodiazepines or other CNS depressants, either under a healthcare professional’s direction or illicitly. Although there are serious risks with combining these medicines, excluding patients from MAT or discharging patients from treatment because of use of benzodiazepines or CNS depressants is not likely to stop them from using these drugs together. Instead, the combined use may continue outside the treatment setting, which could result in more severe outcomes.

Healthcare professionals should take several actions and precautions and develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants. These include:
· 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 their use should continue for 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.

The FDA urges patients and healthcare professionals to report side effects involving buprenorphine, methadone, or other medicines to the FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

SOURCE: US Food and Drug Administration

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