Is it better to stay on Subutex (buprenorphine) during pregnancy?

From the Guidelines

Staying on Subutex (buprenorphine) during pregnancy is generally recommended for women who are already on this medication for opioid use disorder. According to a recent study published in the American Journal of Obstetrics and Gynecology 1, buprenorphine has been shown to be safe and tolerable in pregnancy, with favorable outcomes compared to methadone. The study found that newborn infants exposed to buprenorphine during pregnancy required less medication to treat neonatal abstinence syndrome (NAS) and had a shorter duration of treatment and hospital stays compared to those exposed to methadone.

Some key points to consider when deciding whether to stay on Subutex during pregnancy include:

• The risk of withdrawal if Subutex is abruptly stopped, which can lead to preterm labor, fetal distress, and potential relapse to illicit opioid use
• The importance of coordinated care between an addiction specialist and an obstetrician to manage any medication changes during pregnancy
• The potential benefits of buprenorphine monotherapy (Subutex) over combination therapy with buprenorphine and naloxone (Suboxone) during pregnancy, although data on this topic is limited 1
• The need for careful medication management, particularly if the patient is concurrently using benzodiazepines or other central nervous system depressants 1

In terms of dosage, buprenorphine is typically prescribed in doses ranging from 4-24 mg daily, adjusted based on individual needs to prevent withdrawal symptoms. It is essential to work closely with a healthcare provider to determine the best course of treatment during pregnancy. Overall, the benefits of staying on Subutex during pregnancy, including reducing the risk of withdrawal and relapse, outweigh the potential risks, making it a recommended treatment option for women with opioid use disorder.

From the FDA Drug Label

Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome Available data with buprenorphine hydrochloride in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage

The FDA drug label does not provide sufficient information to determine if it is better to stay on Subutex when pregnant. Key points to consider include:

• Neonatal opioid withdrawal syndrome may occur with the use of opioid analgesics during pregnancy.
• Insufficient data are available to inform a drug-associated risk for major birth defects and miscarriage with buprenorphine hydrochloride.
• Animal studies have shown adverse events, including embryofetal death and skeletal abnormalities, at doses approximately 2 times the maximum recommended human dose. It is essential to consult a healthcare provider to discuss the potential risks and benefits of continuing Subutex during pregnancy 2 2.

From the Research

Opioid Dependence Treatment in Pregnancy

• Opioid dependence in pregnancy carries significant maternal and fetal risks, and providing care for patients with dependence is best done in a multidisciplinary care model addressing the particular needs of this population 3.
• Methadone has been the recommended maintenance treatment, but recent data on buprenorphine (Subutex) identify it as a safe and effective option 3, 4.
• Buprenorphine-naloxone, with a lower abuse risk than buprenorphine monotherapy or methadone, offers a potentially beneficial alternative, but scientific evidence on its effects on pregnancies, fetuses, and newborns is scarce 4.

Comparison of Treatment Options

• A study comparing the outcomes of pregnancies, deliveries, and newborns of women on buprenorphine-naloxone, buprenorphine, or methadone maintenance treatments found that buprenorphine-naloxone and buprenorphine groups showed similar outcomes and did not significantly differ from each other in terms of maternal health during pregnancies, deliveries, or newborns 4.
• The study also found that illicit drug use during pregnancy was common in all groups, but most common in the methadone group, and that the need for pharmacological treatment for neonatal opioid withdrawal syndrome was lower in the buprenorphine-based groups than in the methadone group 4.

Clinical Management

• Comprehensive prenatal care for opioid-dependent women involves the evaluation and management of co-occurring psychiatric disorders, polysubstance use, infectious diseases, social stressors, and counseling regarding the importance of breastfeeding, contraception, and neonatal abstinence syndrome 5.
• General practitioners are often well-placed to support and coordinate care of their opioid-dependent pregnant patients, and referral to specialist services is often appropriate 6.
• The management of opioid dependence during pregnancy requires holistic and comprehensive assessment, and specific issues that may need to be addressed include decision-making regarding the choice of opioid-substitution therapy and the potential for neonatal abstinence syndrome in the newborn 6.