Study Finds No Birth Defect Risks From Suboxone When Compared to Methadone

While Suboxone has been deemed safe for women to use during pregnancy, thousands of lawsuits continue to be pursued by users who claim the sublingual form causes severe tooth decay side effects.

The findings of a new study indicate that exposure to opioid addiction treatments like Suboxone during pregnancy do not appear to negatively harm unborn children when compared to methadone.

The U.S. has been struggling with an opioid addiction epidemic for years. This has led to numerous treatments that require the patient to be slowly weaned off of the drugs to avoid severe withdrawal symptoms.

Buprenorphine and methadone are both prescribed to help opioid addicted patients fight their addiction. However, both medications are also classified as opioids, which has been linked to multiple complications for the unborn children of pregnant women.

A prior study published by Harvard researchers in 2024 found that prenatal exposure to methadone carries a higher risk than buprenorphine of newborns being born with cardiac malformations, septal defects and club foot, as well as central nervous system, urinary and limb malformations. In particular, data indicated that 60.6 out of 1,000 infants exposed to methadone during the first trimester of pregnancy were born with congenital malformations, compared to only 50.9 per 1,000 pregnancies involving buprenorphine exposure.

New findings published in The BMJ on April 15 add support to this data, leading researchers to conclude that buprenorphine, one of the active ingredients in Suboxone, is safe for use during pregnancy.

Suboxone Birth Defects Study

The new study was led by Sabine Friedrich, a Brigham and Women’s Hospital and Harvard Medical School postdoctoral research fellow. Friedrich’s team looked at data on 2.5 million births from 2000 to 2018, finding 18,612 pregnancies involving exposure to buprenorphine or methadone.

According to the findings, 12,635 children were exposed to buprenorphine and 5,390 to methadone. The crude cumulative incidence of any neurodevelopmental disorders in the infants exposed to buprenorphine was 34%, compared to 33% with methadone exposure. However, when the researchers conducted an adjusted analysis, they found that buprenorphine like that used in Suboxone only carried 81% of the risk of neurodevelopmental disorders when compared to methadone exposure.

“The findings of this study suggest no increased risk of long term adverse neurodevelopmental outcomes among children with prenatal exposure to buprenorphine versus methadone, further supporting buprenorphine as a safe treatment option for opioid use disorder during pregnancy.”

– Sabine Friedrich, Prenatal exposure to buprenorphine or methadone and adverse neurodevelopmental outcomes: population based cohort study

These results were also seen in relation to attention deficit/hyperactivity disorder (ADHD) and autism spectrum disorder.

Suboxone Tooth Decay Lawsuits

Buprenorphine is most commonly known for its use in Suboxone film strips, which include naloxone as well. The medication was originally introduced in tablet form, but the manufacturer, Indivior, later reformulated it into a dissolvable film strip.

Despite the widespread use of the drug for its opioid addiction treatment purposes, users have filed thousands of Suboxone lawsuits claiming that the film strips caused tooth enamel erosion, a known characteristic of buprenorphine, which plaintiffs say led to tooth decay and dental damage.

Since February 2024, all federal Suboxone tooth decay lawsuits have been consolidated in the Northern District of Ohio before U.S. District Judge Philip Calabrese as part of a multidistrict litigation (MDL).

Judge Calabrese is charged with guiding the litigation through coordinated discovery and pretrial proceedings and has had the parties preparing to select a group of representative cases for early trial dates. These “bellwether” trials will give the parties a chance to see how juries weigh evidence, testimony and arguments that would arise throughout the litigation.

The judge has scheduled the first trial to begin sometime in March 2028.

Although not binding on other cases, the outcomes of these bellwether trials will be closely watched, as verdicts and payouts may have a significant impact on any Suboxone tooth decay lawsuit settlement agreement.

However, if no Suboxone settlement or other resolution is reached by the end of the bellwether trials and the pretrial proceedings, Judge Calabrese will likely begin remanding the cases back to their originating districts for individual trial dates.

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