Table 4 Publications reporting statistical analyses of the risk of congenital malformation associated with gestational exposure to asthma medication compared with no exposure
ReferenceGestational exposureChildren with congenital malformation(number born to women with asthma/without asthma)Multivariate analysisIncreased risk†
Schatz et al7Inhaled bronchodilators<50/<50*YesNo
Stenius-Aarniala et al11Theophylline10/2NoNo
Schatz et al8β agonists, theophylline, cromolyn, CS, antihistamines, decongestants<50/<50*NoNo
Alexandre et al10β agonists, CS88/981YesNo
Schatz et al39β agonist, ICS, OCS, theophylline, cromoglicates42/0*NoNo
Tamasi et al13SABA, ICS, LABA, OCS, xanthines, sodium cromoglicate511/22322‡NoYes with fenoterol, no with other medications
Blais et al38ICS418/0YesNo
Bakhireva et al37β agonists, leucotriene receptor antagonists9/1YesYes
Kallen et al14SABA, ICS, LABA, other bronchodilators¶, other anti-inflammatories**1263/41223YesYes§
Current publicationSABA, ICS, LABA, OCS, other bronchodilators¶, other anti-inflammatories**704/4420YesNo
  • *Numbers estimated from published percentages (no numbers presented in paper).

  • †Statistically significant increase in malformation with gestational drug exposure (at 5% level).

  • ‡Mostly major malformations but included some minor (clubfoot, pyloric stenosis, undescended testis).

  • §Although system-specific malformations had no generally consistent pattern and statistically significant associations found only for severe cardiac defects, orofacial clefts, anal atresia.

  • ¶Other bronchodilators: aminophylline, theophylline, ephedrine, orciprenaline, tiotropium or ipratropium.

  • **Other anti-inflammatories: cromoglicate, nedocromil, montelukast or zafirlukast.

  • CS, corticosteroid (unspecified formula); ICS, inhaled corticosteroid; LABA, long-acting β agonist; OCS, oral corticosteroid; SABA, short-acting β agonist.