Buprenorphine Transdermal Patch Safety in Pregnancy
The buprenorphine transdermal patch is not recommended for use during pregnancy; sublingual buprenorphine formulations (with or without naloxone) are the preferred and evidence-based options for pregnant women requiring buprenorphine therapy. 1
Key Distinction: Formulation Matters
The critical issue here is that the transdermal patch formulation of buprenorphine has not been studied or validated for use in pregnancy, while sublingual buprenorphine has extensive safety and efficacy data. 1
Evidence for Sublingual Buprenorphine in Pregnancy
Sublingual buprenorphine (monotherapy or with naloxone) is safe and effective during pregnancy, demonstrated in the landmark MOTHER trial comparing 175 pregnant women receiving buprenorphine versus methadone. 1
No increase in birth defects has been associated with buprenorphine use during pregnancy, and longitudinal studies show minimal to no long-term neurodevelopmental impact. 1
Neonatal outcomes favor buprenorphine over methadone: infants exposed to buprenorphine required less medication for neonatal opioid withdrawal syndrome (NOWS), had shorter treatment duration, and shorter hospital stays compared to methadone-exposed infants. 1
Buprenorphine-naloxone combination therapy can be safely continued in women who become pregnant while taking it, despite historical concerns about the naloxone component—these theoretical risks have not been supported by available data. 1
Why the Transdermal Patch is Problematic
The transdermal patch is FDA-approved only for chronic pain management, not for opioid use disorder treatment. 1
Pharmacokinetic data during pregnancy are extremely limited for the transdermal formulation, with only a single case report from 2006 describing use without complications—insufficient evidence for clinical recommendations. 2
Dosing adjustments during pregnancy are well-established for sublingual formulations (higher and more frequent doses may be required, increasing with gestational age), but such data do not exist for transdermal patches. 1
Clinical Recommendations
For Pregnant Women with Opioid Use Disorder
All pregnant women with OUD should be offered maintenance therapy with sublingual methadone or buprenorphine (not transdermal formulations). 1
Sublingual buprenorphine dosing typically ranges from 4-24 mg daily, with a meta-analysis showing 16 mg daily is sufficient to suppress illicit opioid use in most pregnant women, though individual needs vary. 1
Divided dosing (2-4 times daily) may be necessary during pregnancy as gestational age increases. 1
For Pregnant Women with Chronic Pain on Transdermal Buprenorphine
Consider transitioning to sublingual buprenorphine formulations with appropriate dosing adjustments, ideally managed with a pain specialist. 1
Maintain baseline medication throughout pregnancy to prevent withdrawal and manage underlying pain conditions. 1
Multimodal pain management strategies should incorporate non-opioid analgesics (NSAIDs when appropriate, acetaminophen) alongside opioid therapy. 1
Important Caveats
The transdermal patch bypasses first-pass hepatic metabolism (which is 90% for sublingual formulations), potentially providing different pharmacokinetics—but this has not been studied in pregnancy and cannot be assumed safe. 1
Switching between formulations requires careful monitoring: transitioning from methadone to buprenorphine can precipitate withdrawal and is challenging, while switching from buprenorphine to methadone can be done more readily in the absence of sedation. 1
NOWS remains the most consistent adverse effect of any buprenorphine formulation during pregnancy, though severity is generally less than with methadone. 1
Postpartum continuation planning should begin during pregnancy to ensure access to appropriate buprenorphine formulations and prescribers. 1