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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. Untreated opioid addiction in pregnancy is associated with adverse obstetrical outcomes such as low birth weight, preterm birth, and fetal death. 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. 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.

Benefit should outweigh risk 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 physical dependence in the neonate. Comments: -Women should be advised of the risk of neonatal opioid withdrawal and ensure that appropriate treatment will be available. -This drug is not recommended for chronic pain management during pregnancy, adequate contraception should be discussed. -Implant: For women on buprenorphine for opioid addiction, dose adjustments may be required during pregnancy, even if patient was maintained on a stable dose prior to pregnancy; since the implant dose cannot be adjusted, its use is not an appropriate treatment option for women who are pregnant.

See references

Buprenorphine Breastfeeding Warnings

This drug has poor bioavailability and 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.

Benefit should outweigh risk 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. 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 -]):
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. Cerner Multum, Inc. "Australian Product Information." O 0
  7. "Product Information. Subutex (buprenorphine)." Reckitt and Colman Pharmaceuticals Inc, Richmond, VA.

References for breastfeeding information

  1. "Product Information. Butrans (buprenorphine)." Purdue Pharma LP, Stamford, CT.
  2. "Product Information. Subutex (buprenorphine)." Reckitt and Colman Pharmaceuticals Inc, Richmond, VA.
  3. 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 -]):
  4. "Product Information. Buprenex (buprenorphine)." Reckitt and Colman Pharmaceutical, Richmond, VA.
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. "Product Information. Belbuca (buprenorphine)." Endo Pharmaceuticals Solutions Inc, Malvern, PA.
  7. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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