Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to promote the safe adoption of medication-assisted treatment for opioid addiction

FDA Statement

• For Immediate Release: September 20, 2017

Medication-assisted treatment (MAT) – the use of medication combined with counseling and behavioral therapies – is one of the major pillars of the federal response to the opioid epidemic in this country. This type of treatment is an important tool that has the potential to help millions of Americans with an opioid use disorder regain control over their lives. 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. Addressing the epidemic of opioid addiction is my highest public health priority. One element of that effort is promoting more widespread, safe adoption of MAT as a way to help more people overcome addiction.

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. For example, many patients with opioid use disorder might abuse other substances or have a co-existing chronic condition, such as a mental health disorder. This may require separate treatment using medications that, when combined with the MAT drugs methadone or buprenorphine, may pose serious risks. Today, the FDA issued a Drug Safety Communication alerting health care providers and patients of the increased risk of serious side effects when combining these particular MAT drugs with benzodiazepines – often prescribed to treat anxiety, insomnia, or other conditions – and how to address these risks while continuing to maintain patients on MAT. In addition, the FDA also recently strengthened labeling for the MAT drug buprenorphine to emphasize that patients may require treatment indefinitely and should continue treatment for as long as they benefit and as long as the use of MAT contributes to their intended treatment goals.

As noted in the Drug Safety Communication, the co-administration of the MAT drugs methadone or buprenorphine with benzodiazepines or other central nervous system (CNS) depressants can pose serious risks, including difficulty breathing, coma, and death. The FDA’s new alert follows the agency’s warning last year of the risks of using opioid analgesics (to treat pain) or prescription opioid cough products and benzodiazepines at the same time. At that time, more consideration was needed regarding the combined use of these MAT drugs and benzodiazepines or other CNS depressants due to the unique medical needs and benefit-risk considerations for this specific patient population. As a result of that consideration, the FDA’s new advisory that we’re issuing today asks health care providers and patients to be aware of these risks. But at the same time, the 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.

To underscore the importance of appropriately utilizing MAT products, the FDA is requiring changes to MAT drug labels to help decrease the risks of combining these drugs, while taking steps to address situations where the MAT drugs methadone or buprenorphine might be co-administered with benzodiazepines. 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.

Reducing the number of Americans who are addicted to opioids and cutting the rate of new addiction is one of the FDA’s highest priorities. We must do everything possible to address the staggering human toll caused by opioid use disorders, and ensuring patients receive proper treatment for both addiction and coexisting mental health conditions is a critical step in that effort.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.