FDA alters stance on opioid addiction drugs

September 25, 2017

FDA is advising that these 2 opioid addiction medications should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system.

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).

Related: FDA requires warning on opioids

However, the agency is requiring new information on buprenorphine and methadone drug labels along with detailed recommendations for minimizing the use of medication-assisted treatment (MAT) drugs and benzodiazepines (such as Xanax and Klonopin) together.

“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,” FDA said in a new Medwatch Safety Alert. “Careful medication management by healthcare professionals can reduce these risks.”

Related: Top 4 ways US is combating opioid epidemic

In August 2016, FDA issued a Drug Safety Communication warning about the combined use of opioid-containing pain or cough medicines with benzodiazepines or other CNS depressants. FDA said it would continue to evaluate the evidence regarding combined use of benzodiazepines or other CNS depressants with MAT drugs.

Now, FDA says that 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,” the agency said.

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, including:

• Educate 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.

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

• Taper 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 consider other treatment options for these conditions.        

• Recognize 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.

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

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

Read next: FDA panel greenlights Probuphine for opioid addiction