[5/26/16] Today the U.S. Food and Drug Administration (FDA) is requiring safety labeling changes for methadone and buprenorphine products when used by pregnant women for medication-assisted treatment (MAT) of opioid use disorder to ensure providers have complete information about the benefits and risks of these products.
Methadone and buprenorphine can be used for the treatment of pain and/or MAT, which combines medication with counseling and behavioral therapies. MAT plays an important role in treating opioid use disorder. For pregnant women, this treatment may ultimately improve outcomes for them and their babies.
National guidelines from the American College of Obstetricians and Gynecologists (ACOG) and the Substance Abuse and Mental Health Services Administration (SAMHSA), and international guidelines from the World Health Organization, recommend that pregnant women with opioid addiction be treated with methadone or buprenorphine. According to these guidelines, the rationale for MAT during pregnancy is to prevent complications of opioid abuse, addiction and withdrawal, and encourage prenatal care and drug treatment.
However, MAT can also present challenges due to the risk of the developing fetus being exposed to opioids, which can lead to neonatal opioid withdrawal syndrome (NOWS). NOWS can be effectively managed, but may be life-threatening if not recognized and treated.
Since NOWS can result from in utero exposure to opioids – whether medically authorized or illicit – the risk of NOWS from MAT must be balanced against the risk of untreated opioid addiction during pregnancy; an independent advisory committee and numerous reproductive health experts agree this balance is important. If left untreated, illicit opioid use is associated with poor pregnancy outcomes such as low birth weight, preterm birth, or fetal death.
The FDA’s action requiring safety labeling changes for MAT-only methadone and buprenorphine products is intended to appropriately inform prescribers about the risks of NOWS without inadvertently discouraging treatment for pregnant women with opioid addiction.
This action is among a number of steps the agency has taken recently to inform prescribers about the appropriate use of opioid medications. Labels for buprenorphine products that are used to treat pain are already required to provide information to prescribers about the risks associated with NOWS in a boxed warning, which is the FDA’s strongest warning. These new safety labeling change requirements for methadone and buprenorphine products that are used for MAT include a statement in the Warnings and Precautions section about the risk of NOWS, as well as related modifications to the Pregnancy, Dependence, and Patient Counseling Information sections. (A boxed warning for NOWS is not being required for the MAT-only methadone and buprenorphine products.)
Furthermore, as recently outlined in an action plan, the FDA is reassessing its approach to opioid medications to combat this public health crisis and its profound impact on individuals, families and communities across our country.
Expanding access to and the use of MAT to treat opioid use disorder is a key focus area within the evidence-based HHS-wide opioid initiative; the plan also includes informing opioid prescribing practices and increasing the use of naloxone (a rescue medication that can prevent death from overdose).
A few buprenorphine products are solely indicated to treat pain. The buprenorphine products that are indicated only as analgesics already have a boxed warning about NOWS.
One methadone MAT product, Dolophine, is indicated both for treatment of pain and for treatment of opioid addiction, and already has the boxed warning for NOWS. Revisions will be made to Dolophine labeling to clearly communicate the different benefit and risk balance considerations for treatment of pain vs. treatment of addiction. There are no methadone products solely indicated to treat pain.