I remember kids in elementary school in the ’70s with asthma. It seemed rare back then. Not anymore. Statistics seem to bear this out. The prevalence of asthma is increasing worldwide and in particular in the United States. Asthma has risks for all who suffer from it, but people are playing a lot more attention to the issue of pregnancy and asthma and whether asthma medications can cause injury to the expectant mother or the unborn child. Specifically, people are questioning whether asthma drugs like budesonide (Pulmicort) that contained glucocorticoids increase the infant’s risk of developing metabolic and endocrine disorders.
Between 4 and 12% of pregnant women have asthma and 3% use asthma medications during pregnancy. Women with asthma are at an increased risk of complications during pregnancy due to inadequacy in controlling asthma and/or some medications used to manage asthma.
Certainly, doctors are in a Catch 22. Poorly controlled asthma can result in an inadequate supply of oxygen to the fetus. Asthma during pregnancy can lead to preterm labor, cesarean section, and hypertensive disorders, including preeclampsia and placental previa. Severe asthma can result in maternal mortality, fetal mortality, or both. Therefore, management of asthma during pregnancy may be necessary to improve the mothers’ asthma, even if risks are present with the use of such medications. It is always important to weigh the potential risks to the fetus against the benefit of the mother. To do this accurately, drug companies have to tell us what the risks of asthma and pregnancy are. What are they? We don’t know what the drug companies know, but what we do know is mixed.
A recent study published in Pediatrics explored whether or not there is an association between birth defects and maternal use of asthma medications (bronchodilators or anti-inflammatories). This retrospective study reviewed 6,726 unaffected infants and 2,853 infants who were born with 1 or more of the following birth defects: anorectal atresia (malformation of the rectum), diaphragmatic hernia (hole in the diaphragm), esophageal atresia (malformation of the esophagus), limb deficiencies, neural tube defects, or omphalocele (a defect in which the intestines or other organs that stick out of the belly button). The results of this study showed that there were associations between asthma medication use one month prior and during the first three months of pregnancy and anorectal atresia, esophageal atresia, and omphalocele. Anorectal atresia was associated with anti-inflammatory asthma medications, esophageal atresia was associated with bronchodilators, and omphalocele was associated with both categories of asthma medications.
The same researchers also published an article in 2011 in Toxicologyusing the data from the same group of infants. This study focused on 2,711 infants with orofacial clefts and 6,482 unaffected infants. An association was observed between maternal bronchodilator use and cleft lip during the one month prior and the first three months of pregnancy. Albuterol use was found to be associated with cleft palate only and cleft lip only, not cleft lip with cleft palate. The FDA has assigned Albuterol to Category C, a drug that has shown effects in animals, but for which no human data is available. Albuterol is only recommended for use during pregnancy if no alternatives are available and the benefit outweighs the risk. Generally, human data is gathered through randomized controlled trials; however, because of the nature of this particular issue and number of patients required, it is not feasible to undertake such a study, this information must be gathered through retrospective studies. So the science is still developing. But the concern is high.
Similarly, oral corticosteroids have also been shown to increase the risk of cleft lip, cleft palate, and cleft lip with cleft palate. Further, oral corticosteroids have been associated with gestational diabetes, impaired fetal growth, congenital malformations, preeclampsia, and preterm delivery. However, as severe asthma can cause maternal and/or fetal mortality, the potential benefit of using oral corticosteroids in this group of patients outweigh the risks.
A population-based study conducted in New York State and published in Birth Defects Research Part A, Clinical and Molecular Teratology (2009), found that cardiac congenital birth defects were associated with maternal asthma and/or asthma medication use. The study also found that bronchodilators were associated with an increase in the risk of congenital heart defects.
Managing asthma during pregnancy requires benefit/risk analysis. Doctors currently have several tools available to aid in decision making for women with asthma during pregnancy including online databases such as TERIS (Teratogen Information Systems, ), Reprotox, and the Organization of Teratology Information Specialists.
Pharmaceutical manufacturers are currently developing biologics that target more specific parts of the inflammatory process in severe patients. These biologics generally cross the placenta during later stages of fetal development and are less of a threat to the fetus. It is hoped that this new generation of medications will be safer for use during pregnancy.
Are their potential lawsuits to be filed for children who suffer these injuries if their mother was taking budesonide (Pulmicort)? It depends on the case. If you want more information on your child’s potential lawsuit, call 800-553-8082 or get a free online consultation.