Salmeterol Pregnancy and Breastfeeding Warnings

Brand names: Serevent Diskus

Medically reviewed by Drugs.com. Last updated on Sep 25, 2023.

Salmeterol Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Comments:
-Available data from studies and case reports have not found a drug-associated increase in major birth defects, miscarriage, or adverse fetal or maternal outcomes.
-There are clinical considerations for asthma during pregnancy; poorly or moderately controlled asthma is associated with pre-eclampsia, prematurity, low birth weight, and small for gestational age infants.
-Severe asthma is associated with maternal mortality, fetal mortality, or both.
-Closely monitor pregnant patients and adjust medications to optimize asthma control.
-Beta-agonists, including this drug, may potentially interfere with uterine contractility due to a relaxant effect on uterine smooth muscle; use this drug during labor only if benefits clearly outweigh the risks.

Animal studies of oral doses approximately 50 times the maximum recommended human daily inhalation dose (MRHDID) caused teratogenicity characteristic of beta-adrenoreceptor stimulation, including precocious eyelid openings, cleft palate, sternebral fusion, limb and paw flexures, and delayed ossification of frontal cranial bones; no such effects occurred at oral doses 20 times the MRHDID. Doses 973 times the MRHDID was fetotoxic and decreased fertility in survivors. This drug crossed the placenta following oral administration to rodents. Published data in humans do not definitively establish absence of risk, but have not established an association with major birth defects, miscarriage, or adverse fetal or maternal outcomes. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.


AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

See references

Salmeterol Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Drug concentrations in human plasma after inhalation are low; concentrations in breast milk are expected to be low.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

Animal studies of oral doses of 10,000 mg/kg/day salmeterol showed measurable levels in the milk.

See references

Further information

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