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Albuterol Pregnancy and Breastfeeding Warnings

Albuterol is also known as: AccuNeb, Airet, ProAir Digihaler, ProAir HFA, ProAir RespiClick, Proventil, Proventil HFA, Respirol, Ventolin, Ventolin HFA, Volmax, Vospire ER

Medically reviewed by Drugs.com. Last updated on Mar 8, 2019.

Albuterol Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

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

Comments:
-There are no randomized clinical studies of albuterol use during pregnancy, but available information on pregnancy exposure by inhalation do not consistently show miscarriage or major birth defects.
-This drug is known to cross the placental barrier, as evidenced by increases in fetal heart rate.
-Beta-agonists, including this drug, may potentially interfere with uterine contractility.
-In women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women should be closely monitored and the dose adjusted as necessary to maintain optimal control.
-In some countries, intravenous injection presentations of this drug have been approved for delay pre-term labor (tocolytic agent) and should not be used in the management of uncomplicated premature labor.

Epidemiological studies and postmarketing case reports following inhaled administration of this drug do not consistently demonstrate a risk of major birth defects or miscarriage. In animal reproduction studies, subcutaneous administration to pregnant mice evidence of cleft palate at less than and up to 9 times the maximum recommended human daily inhalation dose (MRHDID). A study in pregnant rats demonstrated that drug-related material was transferred from the maternal circulation to the fetus. There are no controlled data in human pregnancy.
During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with this drug. Some of the mothers were taking multiple medications during their pregnancies. A relationship between the use of this drug and congenital anomalies has not been established. Profuse uterine bleeding following spontaneous abortion has been reported after the use of this drug. Special care is required in pregnant diabetic women. 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%.


A pregnancy exposure registry monitors outcomes after exposure to asthma medications during pregnancy. For more information, contact the Mothers To Baby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at http://mothertobaby.org/pregnancystudies/.


AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

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

Albuterol Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

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.
-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.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Lind T, Godfrey KA, Gerrard J, Bryson MR "Continuous salbutamol infusion over 17 weeks to pre-empt premature labour." Lancet 2 (1980): 1165-6
  4. "Product Information. Albuterol Sulfate (albuterol (salbutamol))." Vista Pharm Inc, Birmingham, AL.
  5. Watson NA, Morgan B "Pulmonary oedema and salbutamol in preterm labour. Case report and literature review." Br J Obstet Gynaecol 96 (1989): 1445-8
  6. Rayburn WF, Atkinson BD, Gilbert K, Turnbull GL "Short-term effects of inhaled albuterol on maternal and fetal circulations." Am J Obstet Gynecol 171 (1994): 770-3
  7. "Product Information. Proventil (albuterol)." Schering Laboratories, Kenilworth, NJ.
  8. Mcdonald CF, Burdon JGW "Asthma in pregnancy and lactation - a position paper for the thoracic society of australia and new zealand." Med J Aust 165 (1996): 485-8
  9. Tan SN "Peri-partum pulmonary oedema." Anaesth Intensive Care 19 (1991): 111-3
  10. Martin AJ "Severe unwanted effects associated with betasympathomimetics when used in the treatment of premature labour: causes, incidence and preventative measures." Br J Clin Pract 35 (1981): 325-9
  11. Hawker F "Five cases of pulmonary oedema associated with beta 2-sympathomimetic treatment of premature labour." Anaesth Intensive Care 12 (1984): 159-62
  12. "Product Information. Ventolin (albuterol)." Glaxo Wellcome, Research Triangle Park, NC.
  13. Lunell NO, Joelsson I, Bjorkman U, Lamb P, Persson B "The use of salbutamol in obstetrics." Acta Obstet Gynecol Scand 55 (1976): 333-6
  14. Dombrowski MP "Pharmacologic therapy of asthma during pregnancy." Obstet Gynecol Clin North Am 24 (1997): 559
  15. "Product Information. Albuterol Extended Release (albuterol (salbutamol))." Dava Pharmaceuticals Inc, Fort Lee, NJ.
  16. "Product Information. Albuterol (albuterol (salbutamol))." Physicians Total Care, Tulsa, OK.
  17. Davies AE, Robertson MJ "Pulmonary oedema after the administration of intravenous salbutamol and ergometrine. Case report." Br J Obstet Gynaecol 87 (1980): 539-41

References for breastfeeding information

  1. Mcdonald CF, Burdon JGW "Asthma in pregnancy and lactation - a position paper for the thoracic society of australia and new zealand." Med J Aust 165 (1996): 485-8
  2. "Product Information. Proventil (albuterol)." Schering Laboratories, Kenilworth, NJ.
  3. "Product Information. Ventolin (albuterol)." Glaxo Wellcome, Research Triangle Park, NC.
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Albuterol Sulfate (albuterol (salbutamol))." Vista Pharm Inc, Birmingham, AL.
  6. "Product Information. Albuterol (albuterol (salbutamol))." Physicians Total Care, Tulsa, OK.
  7. "Product Information. Albuterol Extended Release (albuterol (salbutamol))." Dava Pharmaceuticals Inc, Fort Lee, NJ.
  8. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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