Pregnancy and Opioids: The safety of treatments such as methadone

• Opioid use during pregnancy can cause side effects in the infant as well as cause the baby to go through withdrawal after being born.
• Providers of pregnant women with opioid use disorder may prescribe medications such as methadone or buprenorphine as treatment.
• Researchers in Finland recently conducted a review of previously published studies to see how a combination of buprenorphine plus another drug called naloxone compares to other standard treatments for pregnant women with opioid use disorder.

The number of people with opioid use disorder is continually increasing and sometimes people may get pregnant while having the disorder, which can cause many health issues for both the woman and the baby.

To help reduce illicit opioid use in pregnant women and reduce the risk to the fetus, researchers at The Children’s Hospital in Helsinki, Finland, took a look at using a combination of medications in pregnant women with the disorder.

The researchers published their study results in the journal Acta Obstetricia et Gynecologica Scandinavica.

Opioid use overview 

According to the National Institutes of Health (NIH), opioids are “a class of drugs that include the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone, hydrocodone, codeine, morphine, and many others.”

Providers prescribe opioids to treat and manage pain conditions, such as a broken bone or a chronic illness.

Sometimes people abuse or misuse prescription opioids or use illegal ones, which can lead to a person developing opioid use disorder. The NIH noted that around 2.5 million people in the United States have this disorder.

Opioid use disorder is prevalent enough in the United States that the Centers for Disease Control and Prevention (CDC) classified it as an epidemic. According to the CDC, “nearly 75% of the 91,799 drug overdose deaths in 2020 involved an opioid.”

People who have opioid use disorder may experience changes in their brains and body over time. If they try to stop using opioids suddenly, they may experience severe withdrawal symptoms and are at a higher risk of relapse and overdose.

Doctors help people with opioid use disorder by prescribing certain medications to help them come off the drug and reduce withdrawal symptoms.

Examples of medications commonly prescribed for this purpose include:

• naltrexone (Vivitrol)
• buprenorphine (Sublocade)
• methadone (Methadose)
• buprenorphine/naloxone (Suboxone)

How the pregnancy opioid use study was conducted

According to the study authors, while methadone or buprenorphine can help someone with opioid use disorder, these medications still have room for being misused.

The study authors noted that adding naloxone can “prevent parenteral abuse of buprenorphine.”

This drove the authors to conduct a review of other studies to analyze the outcomes of women who took buprenorphine, combined buprenorphine/naloxone, or methadone during their pregnancy.

After reviewing various studies, the authors narrowed their participant list down to 67 women who went through pregnancy and delivery.

They then divided those women into three groups based on which medications they were taking.

The authors analyzed a number of factors in their study. They examined whether the groups used illicit drugs, reduced their maintenance medications, the outcomes of their pregnancy, and their newborn babies’ health.

Analysis shows medication combination is safe 

Overall, the researchers reported that women who took the combination of buprenorphine/naloxone had similar experiences in pregnancy compared to women who took buprenorphine alone.

About 80% of women in the methadone group continued illicit drug use throughout pregnancy compared to 20% of women in the buprenorphine group and 22% of women in the buprenorphine/naloxone group.

The authors were also interested in whether the women’s maintenance doses of their medications decreased during pregnancy (tapering off is the ultimate goal).

Their analysis showed that 79% of women on buprenorphine reduced their maintenance dose. Of women taking buprenorphine/naloxone, 65% reduced their dose. About 40% of women taking methadone reduced their medication.

From an obstetrical standpoint, women of all groups experienced some pregnancy complications (such as preeclampsia and premature rupture of membranes), but the authors said this was on par with the rest of the Finnish population.

After the babies were born, the researchers considered their Apgar scores and birth weights. The Apgar scores indicate how the baby seems in terms of appearance, pulse, grimace, activity, and respiration.

One infant in the buprenorphine/naloxone group had a lower Apgar score and two in the methadone group had lower Apgar scores.

The researchers noted that the infants generally had lower birth weights compared to the average for other Finnish infants. Some of them received a small-for-gestational-age diagnosis: 20% of the buprenorphine group; 19% of the buprenorphine/naloxone group; and 33% of the methadone group.

Overall, the researchers said that “buprenorphine/naloxone appears to be as safe during pregnancy as buprenorphine monotherapy for both mother and newborn.”

“Combination therapy of buprenorphine/naloxone could be a choice for oral opioid maintenance treatment during pregnancy, but larger studies are needed before changing the official recommendations,” said Dr. Minna Kanervo, a study author who works in gynecology and pediatrics at Helsinki University Hospital in Finland.

Expert reactions to opioid study

Dr. Nisarg Patel, an OBGYN with ClinicSpots at the Nisha IVF Center in Ahmedabad, India, spoke with Medical News Today about the study. (Patel was not involved in this study.)

“The study provides important information about the effects of buprenorphine/naloxone, buprenorphine, and methadone use during pregnancy on offspring behavioral outcomes, which can help inform clinical practice and public health policies,” Patel said.

“One of the main benefits that come with using buprenorphine/naloxone during pregnancy is the suppression of opioid withdrawal symptoms and cravings,” he added. “These effects can help reduce the risk of relapse, as well as other physical and psychological problems associated with opioid use.”

Patel noted some weaknesses in the review, including studies with small sample sizes.

“Some studies had small sample sizes, incomplete data, or other methodological limitations, which may affect the reliability of the results,” he said.

Dr. Andrew Novick, a psychiatrist who works at the Center for Women’s Behavioral Health and Wellness at the University of Colorado School of Medicine, not involved in the study, also spoke with MNT.

“This study adds to a growing literature suggesting that giving buprenorphine plus naloxone during pregnancy for the treatment of opioid use disorder is safe and effective,” said Novick.

“There’s been an overall hesitance about the use of opioid antagonists like naloxone in pregnancy because of animal experiments suggesting it might not be safe, but this study and others are really starting to show that these safety concerns in humans are not playing out,” he added.

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