US Medicaid data finds buprenorphine safe for long-term child development

A large US study has found that babies born to mothers who used buprenorphine for opioid addiction during pregnancy had no greater risk of neurodevelopmental disorders such as ADHD and autism than babies born to mothers who took methadone. bmj Today.

The researchers say these findings “support buprenorphine as a safe treatment option for opioid use disorder during pregnancy.”

Buprenorphine and methadone are recommended for the treatment of opioid use disorder during pregnancy. Previous research has shown that buprenorphine is associated with a lower risk of serious health complications for newborns than methadone, but evidence on long-term safety is lacking.

To address this gap, researchers used Medicaid health insurance data for more than 2.5 million live births from 2000 to 2018 to compare the risk of neurodevelopmental disorders in 12,635 children exposed to buprenorphine with 5,390 children exposed to methadone before birth.

The children were tracked until age 8 for conditions including autism, ADHD, speech or language disorders, behavioral disorders and intellectual disability.

The researchers took into account a range of potentially influential factors, including the mother’s age, ethnicity, tobacco and alcohol use, chronic pain, mental health conditions and use of other medications and health care.

After adjustment for these variables, children with prenatal exposure to buprenorphine had a slightly lower risk (19%) of any neurodevelopmental disorder by age 8 compared with children exposed to methadone.

Prenatal exposure to buprenorphine was associated with a lower risk of specific neurodevelopmental disorders than methadone, including ADHD (11% lower risk), speech or language disorders (16% lower risk), and autism (26% lower risk).

For women who were already using buprenorphine or methadone before pregnancy (prevalent use), prenatal exposure to buprenorphine was associated with a 38% lower risk of any neurodevelopmental disorder compared to exposure to methadone.

However, this association was not seen in women who started treatment during pregnancy (new experiment), the authors suggest that further study is needed.

Additional analyzes to further clarify bias also showed that prenatal buprenorphine exposure did not increase the risk of long-term adverse neurodevelopmental outcomes compared with methadone.

This is an observational study, so no firm conclusions can be drawn about cause and effect and the researchers acknowledge some limitations. But they say their use of a large representative health insurance database and extensive sensitivity analysis to examine various sources of bias suggests that the findings are robust.

Thus, they concluded: “The findings of this study show that there is no increased risk of long-term adverse neurodevelopmental outcomes in children with prenatal exposure to buprenorphine versus methadone, supporting buprenorphine as a safe treatment option for opioid use disorder during pregnancy.”

In an associated editorial, Australian researchers say these findings are reassuring and should increase confidence in buprenorphine as an option during pregnancy.

However, they emphasize the importance of methadone for people with higher opioid tolerance or more complex needs and the need to address stigma, fragmented services, and structural inequities that hinder care for people with opioid use disorder.

They concluded that further research is also needed on other outcomes and new formulations, such as long-acting injectable buprenorphine (not currently studied in pregnancy) and to ensure that clinical recommendations remain evidence-based and responsive to evolving drug options for opioid use disorder.