FDA To Providers: Do Not Withhold Medication-Assisted Opioid Addiction Treatment Due To Potential Interactions

Friday, September 22, 2017

FDA is updating its existing warnings on the dangers of combining addiction medications and certain anxiety and insomnia drugs to emphasize that despite the potential for potentially deadly interactions, medication-assisted treatment (MAT) for opioid addiction should not be withheld from patients already taking these anxiety medications. Instead, providers should develop a treatment plan that closely monitors any concomitant use of the drugs, FDA says. The agency announced Wednesday that it is updating both the existing boxed warnings for the drugs and issued a new Drug Safety Communication for providers.

The agency says the move will promote more widespread and safe use of MAT. Gottlieb touted in a Wednesday (Sept. 20) statement the benefits of MAT, which combines medication with counseling and behavioral therapies. He cited the Substance Abuse and Mental Health Services Administration, which says that patients who receive MAT "cut their risk of death from all causes in half," he wrote.

However, MAT drugs containing methadone or buprenorphine do pose risks when used in combination with benzodiazepines or other central nervous system (CNS) depressants.

Despite those risks, Gottlieb said the dangers of not treating an opioid use disorder outweigh the risks of combined use.

"[T]he agency is also reinforcing that MAT should not necessarily be denied to patients taking these other medications. The dangers associated with failing to treat an opioid use disorder can outweigh the risks of co-prescribing MAT and benzodiazepines. Instead, careful management of the patient and coordination of care is recommended," Gottlieb said.

In August 2016, FDA added boxed warnings to the labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines. In that communication, the agency said health care professionals should limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants "only to patients for whom alternative treatment options are inadequate." The communication also warned of the risks of slowed or difficult breathing associated with combining the medications.

FDA is now advising that buprenorphine and methadone "should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS)," the safety communication states.

For the methadone products, information about the interaction with benzodiazepines and other CNS depressants will be added to existing boxed warnings. And expanded guidance on how to manage patients in methadone treatment in opioid treatment programs who are also taking CNS depressants will be added to the label's Warnings and Precautions section.

For buprenorphine products, the agency will require existing statements in the label's Warnings and Precautions section to be expanded and revised "to provide more detailed guidance on managing patients in buprenorphine treatment who are also taking CNS depressants," the communication says.

FDA's new notice to providers says excluding patients from MAT because they are using CNS depressants will not stop them from using the drugs outside of medical professional oversight.

"Many patients with opioid dependence may also use benzodiazepines or other CNS depressants, either under a health care 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," the Drug Safety Communication says.

The required label changes to MAT drugs will also include recommendations for how health care providers can minimize the risks associated with the use of MAT drugs in conjunction with benzodiazepines and other CNS depressants.

The recommendations say health care professionals should educate patients about the risks of combined use; develop strategies to manage the use of prescribed or illicit benzodiazepines or other CNS depressants; taper the benzodiazepine or CNS depressant to discontinuation, if possible; verify whether a patient has been prescribed benzodiazepines or other CNS depressants for anxiety or insomnia and consider other treatment options for those conditions; recognize patients may require MAT medications indefinitely; coordinate care to ensure other prescribers are aware of the patient's buprenorphine or methadone treatment; and monitor for illicit drug use via urine or blood screenings.

In July, the White House's Commission on Combating Drug Addiction and the Opioid Crisis submitted its report on proposals for combating the opioid crisis, in which it called for expanded access to MAT. The commission said all FDA-approved MAT should be offered by authorized providers, and CMS should request state health officials ensure state Medicaid programs cover all FDA-approved MAT drugs for opioid use disorders.

Former Rep. Patrick Kennedy (D-RI), who serves on the White House's commission, argued that approving and providing MAT should be a priority for FDA and medical professionals, respectively. But Kennedy also pointed the finger at doctors, arguing that they are reticent to prescribe MAT.

"There's another issue here, and that is the lack of interest amongst any of the medical professions to actually become a medication-assisted treatment provider. The docs got us into this mess in the first place and yet they're refusing to get us out of it ... the [American Medical Association] ought to have a moral responsibility to ask all of their members to write for medication-assisted treatment. Right now, less than 10 percent of the providers in this country write for medication-assisted treatment, even though Nora Volkow from [National Institute on Drug Abuse] and all the other experts, [American Society of Addiction Medicine], said this is the gold standard for care. Can you imagine only 10 percent of physicians in this country adhering to the gold standard of care with the size of this epidemic the way it is?" he said during Research!America's 2017 National Health Research Forum on Sept. 7.

Read the full article at https://insidehealthpolicy.com/daily-news/fda-providers-do-not-withhold-medication-assisted-opioid-addiction-treatment-due (subscription only). 

Media Contacts

Suzanne Ffolkes
VP Communications
571-482-2710

Anna Briseño
Senior Manager of Communications
571-482-2737

Public sentiment is everything. With public sentiment, nothing can fail; without it nothing can succeed.
Abraham Lincoln