Skip to Content

Buprenorphine Pregnancy and Breastfeeding Warnings

Buprenorphine is also known as: Belbuca, Buprenex, Butrans, Probuphine, Sublocade, Subutex

Buprenorphine Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity; however, reproductive and developmental studies in rats and rabbits have identified adverse events at clinically relevant and higher doses. Limited data from observation studies, case series, and case reports on buprenorphine use during pregnancy have not shown an increased risk of major malformations specifically due to buprenorphine, however, there are limitations in these studies (studies mainly for opioid use disorder). Untreated opioid addiction in pregnancy is associated with adverse outcomes such as low birth weight, preterm birth, and fetal death. Buprenorphine doses in pregnancy often needs to be adjusted, even if the patient has been maintained on a stable dose prior to pregnancy. There are no controlled data in human pregnancy. Opioids cross the placenta and may produce respiratory depression in neonates. This drug is not recommended for use prior to labor, when shorter acting analgesic or other analgesic techniques are more appropriate. Opioid dependent women on buprenorphine may require additional analgesia during labor. Chronic opioid use may cause reduced fertility in females and males of reproductive potential; it is unknown if these effects are reversible. NMP, an excipient in Sublocade(R) extended-release injection for subcutaneous use, has caused preimplantation losses, delayed ossification, reduced fetal weight, developmental delays, and reduced cognitive function at equivalent recommended human doses. Decreased pup survival and malformation and postimplantation losses were reported at 2 and 3 times the human NMP dose. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Not recommended unless benefit expected to outweigh risks AU, UK: Use is contraindicated AU TGA pregnancy category: C US FDA pregnancy category: Not assigned Risk Summary: -Limited data in women maintained on this drug for opioid dependence during pregnancy have not shown an increased risk of major malformations, however, these studies were not designed to appropriately assess risk. -Prolonged use of opioids during pregnancy for medical or non-medical reasons can result in neonatal opioid withdrawal syndrome which may be life-threatening if not recognized and treated. -Based on animal data, use of NMP (an excipient in the extended-release injection that is indicated for the treatment of opioid use disorder) a potential risk to the fetus exists. Comments: -Women should be advised of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. -This drug is not recommended for chronic pain management during pregnancy; adequate contraception should be discussed. -Use of the subdermal implant for maintenance treatment of opioid dependence is not recommended during pregnancy since the dose cannot be adjusted.

See references

Buprenorphine Breastfeeding Warnings

This drug has poor oral bioavailability; is usually given by the sublingual or parenteral route. This drug can increase serum prolactin and may inhibit lactation or milk production. Many authorities recommend women should not breastfeed while using this drug due to the potential for serious adverse events; however, for women who have received this drug for opiate abuse during pregnancy and are stable, women should be encouraged to breastfeed their infants postpartum, unless there is another contraindication, such as use of illicit drugs. If this drug is used, monitor infants closely, the amount of drug in breast milk may not be sufficient to prevent neonatal withdrawal and treatment of infant for neonatal abstinence syndrome (NAS) may be required. If breastfeeding is stopped abruptly, observe for signs and symptoms of opioid withdrawal in the infant.

Not recommended unless benefit expected to outweigh risks AU: Use is contraindicated Excreted into human milk: Yes Comments: -This drug has been used in women undergoing treatment for opioid abuse without apparent harmful effects in their nursing infant; monitor for drowsiness, adequate weight gain, and developmental milestones. -In situations other than opioid dependence, breastfeeding is not recommended because of the potential for serious adverse reactions including excess sedation and respiratory depression.

See references

References for pregnancy information

  1. "Product Information. Butrans (buprenorphine)." Purdue Pharma LP, Stamford, CT.
  2. "Product Information. Buprenex (buprenorphine)." Reckitt and Colman Pharmaceutical, Richmond, VA.
  3. "Product Information. Belbuca (buprenorphine)." Endo Pharmaceuticals Solutions Inc, Malvern, PA.
  4. "Product Information. Sublocade (buprenorphine)." Reckitt Benckiser Pharmaceuticals Inc, Richmond, VA.
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. "Product Information. Subutex (buprenorphine)." Reckitt and Colman Pharmaceuticals Inc, Richmond, VA.
  7. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  8. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Butrans (buprenorphine)." Purdue Pharma LP, Stamford, CT.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. "Product Information. Sublocade (buprenorphine)." Reckitt Benckiser Pharmaceuticals Inc, Richmond, VA.
  4. "Product Information. Belbuca (buprenorphine)." Endo Pharmaceuticals Solutions Inc, Malvern, PA.
  5. "Product Information. Subutex (buprenorphine)." Reckitt and Colman Pharmaceuticals Inc, Richmond, VA.
  6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  7. "Product Information. Buprenex (buprenorphine)." Reckitt and Colman Pharmaceutical, Richmond, VA.
  8. Cerner Multum, Inc. "Australian Product Information." O 0

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide