Alfentanil Pregnancy and Breastfeeding Warnings

Brand names: Alfenta

Alfentanil Pregnancy Warnings

Benefit should outweigh risk

AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned

Risk Summary: Available data in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage; prolonged use during pregnancy may cause neonatal opioid withdrawal syndrome.

Comments:
-Neonates exposed to opioid analgesics during labor should be monitored for signs of excess sedation and respiratory depression.
-Prolonged maternal use of opioids during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.

Embryocidal effects have been observed in rats and rabbits given doses 2.5 times the upper human dose for a period of 10 days to over 30 days although these effect could have been due to maternal toxicity (decreased food consumption with increased mortality) following prolonged drug administration. This drug rapidly crosses the placenta and may produce respiratory depression in the neonate. This drug is generally not recommended for use in pregnant women during or immediately prior to labor when other analgesic techniques are more appropriate. As with other narcotics, these effects can be quickly reversed with naloxone. There are no adequate and well controlled studies in pregnant women.

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.

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Alfentanil Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-Breastfeeding is not recommended for 24 hours following maternal administration.
-Breastfed infants should be monitored for excess sedation and respiratory depression.

Epidural or IV use during labor or for a short-time immediately postpartum is not expected to cause adverse effects in breastfed infants. In a study of 9 women who received 50 mcg initially and then 10 mcg as needed during tubal ligation surgery under general anesthesia, drug levels at 4 and 28 hours after last injection were 0.88 ng/mL and negligible, respectively.

See references

Further information

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