Birth Defect Risk Higher With Methadone Than Suboxone: Study

Use of buprenorphine, the active ingredient in Suboxone and other opioid addiction treatments, during the first trimester of pregnancy was associated with a lower risk of most congenital malformations than methadone.

The findings of a new study suggests that pregnant women seeking treatment for opioid addiction may face a higher risk of delivering a child with birth defects if they use methadone, compared to use of Suboxone or other buprenorphine drugs.

Buprenorphine and methadone are two treatments commonly prescribed to help patients with opioid use disorder to break their addictions. Both drugs are opioids, and opioid exposure is known to cause birth defects, known as congenital malformations.

However, researchers from Brigham and Women’s Hospital and Harvard Medical School warned that little was known about the effects of the opioid addiction treatments on the unborn child.

The researchers conducted a population-based cohort study using data from Medicaid beneficiaries in the U.S. from 2000 to 2018, and published their findings published on January 22 in JAMA Internal Medicine.

The study involved data on a total of 13,360 pregnancies from 90 days before conception to one month after delivery. The researchers looked for methadone use and buprenorphine use during the first trimester.

According to the findings, 60.6 infants out of 1,000 were born with congenital malformations if their mother took methadone in the first trimester of pregnancy. That compares to a rate of only 50.9 per 1,000 pregnancies involving buprenorphine use.

In utero exposure to buprenorphine faced a lower risk of her child being born with cardiac malformations, septal defects, and club foot. It was also linked to a lower risk of central nervous system, urinary and limb malformations than methadone, the data indicates.

However, using Suboxone and other buprenorphine-based drugs, like Belbuca, Buprenex and Probuphine, appear to carry a higher risk of gastrointestinal malformations, the researchers noted.

“In this cohort study, the risk of most malformations previously associated with opioid exposure was lower in buprenorphine-exposed infants compared with methadone-exposed infants, independent of measured confounders,” the researchers concluded. “Malformation risk is one factor that informs the individualized patient decision regarding medications for opioid use disorder in pregnancy.”

Suboxone Tooth Decay Lawsuits

The findings come at a time when Suboxone film strips are facing growing scrutiny and litigation over their links to tooth decay.

Suboxone (buprenorphine and naloxone) was first introduced in 2002, as a dissolvable tablet used for treatment of recovering opioid addicts. The drug makers subsequently introduced a Suboxone film version in 2013, which is placed under the tongue or inside the cheek. However, side effects of Suboxone film have been linked to a staggering number of reports involving ruined teeth, which may decay, rot and fall out of the mouth.

It was not until June 2022 that the drug makers provided updated warnings about the Suboxone side effects, disclosing for the first time that use of the drug was associated with irreversible tooth damage, and instructing doctors to monitor dental health during treatments.

The manufacturers now face a growing number of Suboxone lawsuits, each raising similar allegations that users could have avoided permanently ruining their teeth if earlier warnings had been provided for consumers and the medical community.