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• W2014178544 abstract "Current international asthma prescribing guidelines endorse either an inhaled corticosteroid (ICS) or the combination of an ICS with a long-acting β-agonist (LABA) controller medication for pregnant women with moderate or severe persistent asthma. These recommendations were knowingly generated in the absence of conclusive fetal safety data.1National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program Asthma and Pregnancy Working GroupNAEPP expert panel report. Managing asthma during pregnancy: recommendations for pharmacologic treatment—2004 update.J Allergy Clin Immunol. 2005; 115: 34-46Abstract Full Text Full Text PDF PubMed Scopus (221) Google Scholar Although prior studies of the inhaled steroid budesonide and short-acting β-agonist medication data suggested negligible fetal risk, the teratogenic potential for other ICS and LABA combinations had not been definitively excluded. Earlier data suggesting cleft lip and palate risks with oral corticosteroid exposure implied a possible hazard of ICSs.2Park-Wyllie L. Mazzotta P. Pastuszak A. Moretti M.E. Beique L. Hunnisett L. et al.Birth defects after maternal exposure to corticosteroids: prospective cohort study and meta-analysis of epidemiological studies.Teratology. 2000; 62: 385-392Crossref PubMed Scopus (670) Google Scholar To date, the vast majority of studies have not found risk associations with ICSs, with a few important exceptions.3Vasilakis-Scaramozza C. Aschengrau A. Cabral H.J. Jick S.S. Asthma drugs and the risk of congenital anomalies.Pharmacotherapy. 2013; 33: 363-368Crossref PubMed Scopus (22) Google Scholar Weak association of ICSs with relatively severe cardiac defects, orofacial clefts, and anal atresia4Källén B. Otterblad Olausson P. Use of anti-asthmatic drugs during pregnancy. 3. Congenital malformations in the infants.Eur J Clin Pharmacol. 2007; 63: 383-388Crossref PubMed Scopus (91) Google Scholar was noted in one study. First-trimester high-dose ICS exposure was associated with a 63% increased risk of defects compared with low and medium doses, raising concern about heightened sensitivity during the first trimester with a dose-response effect.5Blais L. Beauchesne M.F. Lemière C. Elftouh N. High doses of inhaled corticosteroids during the first trimester of pregnancy and congenital malformations.J Allergy Clin Immunol. 2009; 124: 1229-1234.e4Abstract Full Text Full Text PDF PubMed Scopus (74) Google Scholar Animal studies of high-dose LABAs were variably associated with delayed ossification, decreased fetal weight, and other defects. However, most human LABA studies have suggested no increased risk, with the exception of one study that demonstrated increased risk of cardiac and other malformations. A recent systematic review found LABA studies underpowered and limited overall.6Eltonsy S. Kettani F.Z. Blais L. Beta2-agonists use during pregnancy and perinatal outcomes: a systematic review.Respir Med. 2014; 108: 9-33Abstract Full Text Full Text PDF PubMed Scopus (23) Google Scholar Decisions regarding a step up to higher doses of ICSs or addition of a LABA to a regimen remain controversial, especially during pregnancy. In this issue of the Journal, Eltonsy et al7Eltonsy S. Forget A. Beauchesne M.F. Blais L. Risk of congenital malformations for asthmatic pregnant women using a long-acting β2-agonist and inhaled corticosteroid combination versus higher-dose inhaled corticosteroid monotherapy.J Allergy Clin Immunol. 2015; 135: 123-130Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar address whether the risk of major congenital malformations differed between asthmatic mothers treated during the first trimester with higher-dose ICSs versus lower-dose ICS/LABA combination regimens. This retrospective cohort study identified singleton deliveries by mothers given a diagnosis of asthma through a panprovincial hospitalization database and reviewed prescription claims records shortly before and during the calculated first-trimester period. The authors found no significant risk differences between the 2 exposures tiered for medium- and high-dose ICSs. Cardiac malformations were the most prevalent in all cohorts. These studies, and many similar retrospective fetal safety studies reviewing prescription claims and coded diagnoses, are intrinsically imperfect. Confounding factors that affect both exposure and outcome, such as alcohol, antenatal care, and environmental teratogens, cannot be easily addressed because of the nature of the design. Medication exposure is approximated, yet poor adherence and sporadic medication use are probable. Risks specific to a single drug might be overlooked when a pharmaceutical class as a whole is studied. Occult, minor, and delayed diagnoses of malformations might also be missed, in addition to nonviable fetal malformations resulting in miscarriages. Given these concerns, even very large and long-duration studies might remain underpowered. Nevertheless, confidence to prescribe asthma controller medication to pregnant women has been strengthened with studies such as that by Eltonsy et al7Eltonsy S. Forget A. Beauchesne M.F. Blais L. Risk of congenital malformations for asthmatic pregnant women using a long-acting β2-agonist and inhaled corticosteroid combination versus higher-dose inhaled corticosteroid monotherapy.J Allergy Clin Immunol. 2015; 135: 123-130Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar and others over the past decade. Yet the practical problem is not the absence of a hypothetically perfect study that conclusively excludes any teratogenicity and fetotoxicity. Instead, the greater problem is the well-described risk of significant maternofetal morbidity when asthma is poorly controlled. Overwhelmingly, meta-analyses suggest an overall increased risk for adverse outcomes among women with poor asthma control, including low birth weight, small for gestational age fetuses, preeclampsia, and preterm labor.8Murphy V.E. Namazy J.A. Powell H. Schatz M. Chambers C. Attia J. et al.A meta-analysis of adverse perinatal outcomes in women with asthma.BJOG. 2011; 118: 1314-1323Crossref PubMed Scopus (223) Google Scholar, 9Wang G. Murphy V.E. Namazy J. Powell H. Schatz M. Chambers C. et al.The risk of maternal and placental complications in pregnant women with asthma: a systematic review and meta-analysis.J Matern Fetal Neonatal Med. 2014; 27: 934-942Crossref PubMed Scopus (62) Google Scholar Multiple prospective studies suggest that ICS controllers drastically reduce the risk of acute asthma flares during pregnancy.10Schatz M. Leibman C. Inhaled corticosteroid use and outcomes in pregnancy.Ann Allergy Asthma Immunol. 2005; 95: 234-238Abstract Full Text PDF PubMed Scopus (46) Google Scholar Furthermore, LABAs and ICSs were not associated with worsened perinatal outcomes of low birth weight, small for gestational age, or preterm labor.11Cossette B. Forget A. Beauchesne M.-F. Rey E. Lemière C. Larivée P. et al.Impact of maternal use of asthma-controller therapy on perinatal outcomes.Thorax. 2013; 68: 724-730Crossref PubMed Scopus (46) Google Scholar Despite the risks associated with poor asthma control, worsened adherence and inappropriate prescribing during pregnancy appear commonplace. Discontinuation of asthma medications early in pregnancy was observed in one study12Enriquez R. Wu P. Griffin M.R. Gebretsadik T. Shintani A. Mitchel E. et al.Cessation of asthma medication in early pregnancy.Am J Obstet Gynecol. 2006; 195: 149-153Abstract Full Text Full Text PDF PubMed Scopus (89) Google Scholar; another study found that ICS prescription claims decreased by more than a third after a pregnancy diagnosis.10Schatz M. Leibman C. Inhaled corticosteroid use and outcomes in pregnancy.Ann Allergy Asthma Immunol. 2005; 95: 234-238Abstract Full Text PDF PubMed Scopus (46) Google Scholar Nearly 2 of 5 of women filled just 1 prescription for asthma medication during pregnancy, and a separate study found only 6.5% of pregnant women filled 2 or more controller prescriptions.13Hansen C. Joski P. Freiman H. Andrade S. Toh S. Dublin S. et al.Medication exposure in pregnancy risk evaluation program: the prevalence of asthma medication use during pregnancy.Matern Child Health J. 2013; 17: 1611-1621Crossref PubMed Scopus (36) Google Scholar, 14Enriquez R. Griffin M.R. Carroll K.N. Wu P. Cooper W.O. Gebretsadik T. et al.Effect of maternal asthma and asthma control on pregnancy and perinatal outcomes.J Allergy Clin Immunol. 2007; 120: 625-630Abstract Full Text Full Text PDF PubMed Scopus (109) Google Scholar Erroneous beliefs might explain poor adherence. One experiential study found that many asthmatic women inaccurately assessed ICS teratogenicity and presumed asthma was a low priority of the medical provider. Additionally, a desire for an “all-natural pregnancy” without medications was commonly endorsed.15Lim A.S. Stewart K. Abramson M.J. Ryan K. George J. Asthma during pregnancy: the experiences, concerns and views of pregnant women with asthma.J Asthma. 2012; 49: 474-479Crossref PubMed Scopus (48) Google Scholar Poor medication adherence during pregnancy also appeared to be highly associated with the belief that it is better to abstain from medication or consider herbal remedies, despite being ill.16Lupattelli A. Spigset O. Nordeng H. Adherence to medication for chronic disorders during pregnancy: results from a multinational study.Int J Clin Pharmacol. 2014; 36: 145-153Crossref PubMed Scopus (62) Google Scholar Despite the apparent contradictions of these beliefs with medical recommendations, one international study found that pregnant women consult an average of 3 sources as part of their medication decision-making process, including medical providers, the Internet, nurses, pharmacists, friends, and drug information referral centers.17Hämeen-Anttila K. Nordeng H. Kokki E. Jyrkkä J. Lupattelli A. Vainio K. et al.Multiple information sources and consequences of conflicting information about medicine use during pregnancy: a multinational Internet-based survey.J Med Internet Res. 2014; 16: e60Crossref PubMed Scopus (57) Google Scholar Altered asthma medication prescribing practices during pregnancy have also been noted. Pregnant asthmatic patients were less likely to receive oral corticosteroids both in emergency departments and on discharge.18McCallister J.W. Benninger C.G. Frey H.A. Phillips G.S. Mastronarde J.G. Pregnancy related treatment disparities of acute asthma exacerbations in the emergency department.Respir Med. 2011; 105: 1434-1440Abstract Full Text Full Text PDF PubMed Scopus (30) Google Scholar Despite accurate assessment of the safety of ICSs or LABAs in pregnancy, general practitioners lacked confidence and knowledge regarding prescribing recommendations for pregnant women with deteriorating asthma control.19Lim A.S. Stewart K. Abramson M.J. George J. Management of asthma in pregnant women by general practitioners: a cross sectional survey.BMC Fam Pract. 2011; 12: 121Crossref PubMed Scopus (42) Google Scholar Lettered grading tools, such as the US Food and Drug Administration's system and similar systems worldwide, are a widely used resource for medication decision making in pregnancy by both patients and prescribers. Currently, the US Food and Drug Administration has classified all ICSs and combination drugs in pregnancy as category C, with the exception of budesonide (category B). The grading incorporates risk/benefit considerations rather than comparable risk, thus a category X medication could impart less fetal risk than a category C drug yet lack any potential for health benefit. As a result of widespread criticism, the US Food and Drug Administration's proposed rule plans to retire the simplistic lettered grading system in exchange for risk conclusion statements, which better explain the inherent complexities of risk and benefit.20Ramoz L.L. Patel-Shori N.M. Recent changes in pregnancy and lactation labeling: retirement of risk categories.Pharmacotherapy. 2014; 34: 389-395Crossref PubMed Scopus (52) Google Scholar In conclusion, according to National Asthma Education and Prevention Program recommendations, “it is safer for pregnant women with asthma to be treated with asthma medications than for them to have asthma symptoms and exacerbations.”1National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program Asthma and Pregnancy Working GroupNAEPP expert panel report. Managing asthma during pregnancy: recommendations for pharmacologic treatment—2004 update.J Allergy Clin Immunol. 2005; 115: 34-46Abstract Full Text Full Text PDF PubMed Scopus (221) Google Scholar Multiple international asthma management parameters endorse similar claims. With substantial evidence suggesting poor maternofetal outcomes with uncontrolled asthma and newer data that largely lack any consistent evidence for teratogenicity, the asthma community needs to redouble its efforts to promote medication adherence and achieve disease control in pregnant asthmatic women. Significant opportunities for intervention exist. Greater attention should be paid to patients' beliefs regarding asthma medications, specifically viewpoints regarding necessity and risk of treatment.21Menckeberg T.T. Bouvy M.L. Bracke M. Kaptein A.A. Leufkens H.G. Raaijmakers J.A.M. et al.Beliefs about medicines predict refill adherence to inhaled corticosteroids.J Psychosom Res. 2008; 64: 47-54Abstract Full Text Full Text PDF PubMed Scopus (263) Google Scholar Recommended risk communication strategies include using positive framing and accommodating for poor numeracy skills with well-designed visual aids and discussing absolute rather than relative risk.22Conover E.A. Polifka J.E. The art and science of teratogen risk communication.Am J Med Genet C Semin Med Genet. 2011; 157: 227-233Crossref Scopus (13) Google Scholar Frank discussions of risk and benefit, rather than reliance on the lettered grading systems, might also be beneficial. Additionally, increased awareness and use of teratogen information specialists, who offer resources such as literature and hotlines, might help address difficult questions beyond the scope of a prescriber's expertise. Ultimately, shifting popular beliefs against medication use during pregnancy might be the toughest battle. The burden now on the asthma community is to convert both prescribers and asthmatic patients to the belief that a truly natural pregnancy is one with controlled asthma and not one without asthma controllers. Risk of congenital malformations for asthmatic pregnant women using a long-acting β2-agonist and inhaled corticosteroid combination versus higher-dose inhaled corticosteroid monotherapyJournal of Allergy and Clinical ImmunologyVol. 135Issue 1PreviewCurrent recommendations for managing persistent asthma during pregnancy when low-dose inhaled corticosteroids (ICSs) are insufficient include adding a long-acting β2-agonist (LABA) or increasing the ICS dose. However, there are no data to help clinicians evaluate the safest regimen during pregnancy. Full-Text PDF" @default.
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• W2014178544 title "Perception versus reality: The saga of inhaled asthma controller medication and fetal risk" @default.
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