Is It Safe to Take Subutex While Pregnant?

Subutex is the brand name of the opioid agonist buprenorphine, and is often used in medication-assisted treatment (MAT) plans for opioid addiction. Taking Subutex while pregnant may be recommended for women who want to overcome a physical dependence on opioids, but given that this drug is relatively obscure, many women ask medical professionals, “Can I take Subutex while pregnant?”

Unfortunately, no clear consensus exists on whether taking Subutex while pregnant is safe. According to the Substance Abuse and Mental Health Services Administration, limited data suggests that buprenorphine use during pregnancy does not pose significant risks to a mother or fetus. However, the Food and Drug Administration (FDA) classifies buprenorphine products (Subutex) as category “C” medications, meaning the risk of adverse effects during pregnancy cannot be entirely ruled out.

What Is Subutex?

Subutex, or buprenorphine, is an opioid agonist and a relatively new medication used in drug replacement therapy for opioid use disorders. To help someone overcome addiction, Subutex binds to the brain’s opioid receptors, both stimulating and suppressing the receptors. This helps placate drug cravings while blocking the effects of opioid drugs. 

Despite being designed to help end a substance use disorder, Subutex can be habit-forming. A person’s body can become accustomed to, or dependent on, the effects of Subutex and the individual may rely on the drug for relief, even after therapy ends. In this way, Subutex use is not without risk, meaning Subutex and pregnancy may not be the safest combination.

How Can Subutex Affect Your Baby?

Women who use Subutex as part of MAT may wonder, “Can you take Subutex while pregnant?” The simple answer appears to be “yes,” because Subutex is frequently used in prenatal MAT, is not an opioid itself and carries less abuse potential than most prescription drugs. However, the risks of taking Subutex while pregnant remain largely undefined by the medical community and drug manufacturers, so expectant mothers should be wary of taking Subutex while pregnant.

The FDA assigns common drugs different letter codes based on their safety for use during pregnancy. Safety codes are “A,” “B,” “C,” “D,” and “X,” with drugs in the “A” category being the safest for prenatal use. Drugs that are proven to cause birth defects fall in the “X” category. Currently, Subutex is in the middle, in the “C” category for use during pregnancy. Like with the other drugs in the “C” category, it is unknown whether buprenorphine can severely harm an unborn baby as there are no well-controlled studies in humans that prove the risks of taking Subutex while pregnant. Essentially, this means that taking Subutex while pregnant may be safe, but there is little scientific evidence to prove the complete safety, or harmful nature, of the prenatal use of Subutex.

Subutex and Neonatal Abstinence Syndrome

While the FDA has not ruled out Subutex as a dangerous drug to use during pregnancy, the use of buprenorphine during pregnancy may be linked to the development of neonatal abstinence syndrome (NAS). However, this is relatively rare, and NAS is mostly associated with the prenatal use of opioids, the type of drugs that Subutex is designed to help people stop using. If a newborn develops NAS from their mother’s prenatal Subutex use, a likely explanation could be that the mother was addicted to opioids and taking Subutex while pregnant to overcome her addiction.

If a pregnant woman ingests opioids, especially in the final weeks of pregnancy, her baby can be born addicted to drugs and may experience NAS. This condition is usually only caused by prenatal opioid use but has been documented in cases where buprenorphine (Subutex) was used during pregnancy. Symptoms of NAS include:

• Blotchy skin
• Excessive crying
• Diarrhea
• Fever
• Hyperactivity
• Trouble feeding, sleeping and gaining weight
• Seizures

NAS can also cause low birth weight, heart defects and other birth defects and developmental challenges. Because prenatal buprenorphine use can lead to NAS, the risks of taking Subutex while pregnant often outweigh the benefits.

Risks of Taking Subutex While Pregnant

For a woman who faces an opioid addiction, Subutex use can spur its own form of substance use disorder if she becomes dependent on the drug’s effects. If the woman is expecting a baby, the main risk of taking Subutex while pregnant is that prenatal buprenorphine use may lead to the development of NAS. If the mother is addicted to opioids and taking Subutex to overcome an addiction, other risks of taking Subutex while pregnant can include an impaired ability to care for her baby and potential time lost with the child while she attends drug rehab.

As a rule, pregnant women may use Subutex if the benefits to the mother (e.g., to overcome opioid addiction) outweigh the potential risks to the unborn baby. This is an important decision that cannot be taken lightly and warrants an open and honest conversation between an expectant mother and her obstetrician or rehab center treatment team.

Alternatives to Taking Subutex While Pregnant

If an expectant mother is considering alternatives to Subutex while pregnant, she is likely looking for other options to treat her opioid addiction. Given that the American College of Obstetricians and Gynecologists and the American Society of Addiction Medicine recognize both methadone and buprenorphine as safe and effective medications to treat prenatal opioid addiction, if a woman is nervous about using Subutex, she can opt for methadone treatment. 

Methadone is the current standard of care for treating prenatal opioid addiction. If a woman takes methadone while pregnant as part of MAT, she should not stop using the drug, since the withdrawal symptoms of methadone can cause stillbirth, fetal distress and premature delivery. Most women can use methadone through an outpatient program that communicates with their obstetrician. 

Other Treatment Options for Opioid Addiction While Pregnant

Facing an opioid addiction while pregnant means monitoring one’s own health, and that of an unborn baby. This may seem overwhelming, especially when experienced with the pangs of pregnancy and struggles of a substance use disorder simultaneously. However, there are ways to overcome addiction while maintaining the health and safety of a mother and her unborn baby. 

Many women in a similar situation search for answers to the question, “What are some alternatives for treating opioid addiction while pregnant?” Common recommendations may vary, and include solutions like: 

• Enroll in methadone maintenance therapy: Methadone is the most widely used drug in MAT for pregnant women. 
• Start slow-release morphine maintenance therapy: In MAT, small doses of morphine can be substituted for methadone or buprenorphine if neither drug is available. 
• Begin a medical detox program: Medical detox may be recommended for some pregnant women who are addicted to opioids as it effectively cleanses the body of opioids. However, as detox is physically demanding, it is not the best option for pregnant women. Many rehab centers, including The Recovery Village, do not offer detox treatment for pregnant women as it can pose significant risks to their health.

Subutex and pregnancy rarely go well together, and there are healthier treatment options available for expectant mothers who face an opioid addiction. If you are not pregnant and struggle with a Subutex addiction, call The Recovery Village to speak with a representative who cares and can help guide you toward a treatment center and program that meets your needs.