Salmeterol in Pregnancy and Breastfeeding
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Salmeterol xinafoate (Serevent Diskus «)
Bronchodilator, inhaled ▀ 2-agonist. Molecular weight:603.8

Among 47 infants whose mothers used salmeterol during early pregnancy, one case of Aarskog syndrome (short stature, musculoskeletal, and genital anomalies) was reported which was unlikely to be associated with salmeterol exposure [1].

Preliminary data from The Organization of Teratology Information Services (OTIS)  prospective cohort study of asthma medications in pregnancy did not support an association between salmeterol and major malformations, growth disturbances, spontaneous abortion, premature delivery, or preeclampsia. The OTIS study compared the outcomes of 126  mothers who used salmeterol during pregnancy ( 90% had used the drug during first trimester) with 91 mothers who used only short-acting beta agonists and 115 non-asthmatic women. Malformations in the salmeterol group included 1 case of bicuspid aorta with penoscrotal fusion, 1 case of bilateral and 3 cases of unilateral inguinal hernia [2].

The American College of Obstetricians and Gynecologists (ACOG) and The American College of Allergy, Asthma and Immunology (ACAAI) would not recommended salmeterol for use during pregnancy in preference to older ▀ 2-agonists, cromolyn or beclomethasone. However, salmeterol may be beneficial for patients who have moderate-severe asthma and have shown a good response to this drug prior to pregnancy [3].

BREAST FEEDING: "Since there are no data from controlled trials on the use of salmeterol xinafoate by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Plasma levels of salmeterol after inhaled therapeutic doses are very low. Caution should be exercised when salmeterol xinafoate is administered to a nursing woman"[4].


1. Wilton LV, Pearce GL, Martin RM, Mackay FJ, Mann RD. The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol. 1998;105:882-9. MEDLINE
2. Jones KL et al. Salmeterol Use and Pregnancy Outcome: A Prospective Multi-Center Study. American Academy of Allergy, Asthma and Immunology 58th annual meeting. New York, New York, USA. March 1-6, 2002. J Allergy Clin Immunol. [Abstract] 2002 ;109:S21-446. MEDLINE
3. The use of newer asthma and allergy medications during pregnancy. Position Statement. The American College of Obstetricians and Gynecologists (ACOG) and The American College of Allergy, Asthma and Immunology (ACAAI). Ann Allergy Asthma Immunol. 2000;84:475-480. MEDLINE
4. Serevent« Diskus« package insert, GlaxoSmithKline.2003,

Created: 11/27/2002
Last Update: 12/04/2003

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