Citing the harms of untreated opioid use disorders, the federal Food and Drug Administration (FDA) says that benzodiazepine use should not preclude the use of medication-assisted treatment (MAT) for opioid addiction with methadone or buprenorphine.
In a September 20 drug safety communication, the FDA states that “buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS).” While it is true that combining these drugs can cause serious side effects, “the harm caused by untreated opioid addiction can outweigh these risks.”
By using careful medication management, health care professionals can reduce the risks, the FDA said. Labeling changes will be required for buprenorphine and methadone.
“Buprenorphine and methadone help people reduce or stop their abuse of opioids, including prescription pain medications and heroin,” the FDA said. “These medications are often used in combination with counseling and behavioral therapies, and patients can be treated with them indefinitely.”
Benzodiazepine use can occur either under a health care professional’s prescription, or illicitly, the FDA said. In either case, excluding or discharging patients from MAT because of the use of benzodiazepines or other CNS depressants won’t stop patients from combining the drugs. On the contrary—the combined use would continue outside the treatment setting, which could have even worse outcomes, the FDA said.
‘Win for Individualized Care’
“This is definitely a win for individualized care,” said Zac Talbott, CADC II, ICADC, CMA, program director of Counseling Solutions Treatment Centers, opioid treatment programs (OTPs) based in Chatsworth, Georgia and Murphy, North Carolina, of the FDA guidance. “It is in line with what credible voices in the OTP world have been saying as well.”
Noting that the concept was also stated in the benzodiazepine guidelines from the American Association for the Treatment of Opioid Dependence, previewed at the conference in Baltimore last year, Mr. Talbott said that policies need to be geared towards individual patients. “While it is critical we utilize caution when dispensing methadone or buprenorphine to patients prescribed other CNS depressants, blanket no-benzodiazepine policies are the opposite of the individualized treatment mandated by the federal accreditation guidelines,” he told AT Forum.
Treatment professionals should develop a treatment plan when patients are using benzodiazepines or other CNS depressants in combination with methadone or buprenorphine, according to the FDA.
- Educating patients about the serious risks of combined use, including overdose and death, that can occur with CNS depressants
- Developing strategies to manage concurrent administration of benzodiazepines or other CNS depressants—used as prescribed, or illicitly—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 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’s announcement follows the August 2016 drug safety communication from the agency warning about combining opioid-containing pain or cough medicines with benzodiazepines or other CNS depressants. Continued review by the FDA, based on a study conducted in Sweden, led to the decision to add information to the existing boxed warning for methadone products about the risks of slowed or difficult breathing and death when benzodiazepines or other CNS depressants are combined with the medication.
For the Warnings and Precautions section, there will be expanded guidance on how to manage patients in methadone treatment in OTPs who are also taking CNS depressants. Buprenorphine products, on the other hand, will have only an expanded and revised statement in the warnings and precautions section on managing patients in buprenorphine treatment who are also taking CNS depressants.