With 64% of pregnant women in the U.S. taking at least one medication during pregnancy, experts are arguing that it’s unethical not to include them in the testing of new drugs.
In the United States, 64% of women take at least one prescription drug during their pregnancy.1 A recent editorial in Drug and Therapeutics Bulletin argues that it is unethical to exclude pregnant women from drug trials, stating:
“With increasing awareness that the intrauterine environment is important for the long-term development of children, it is ever more important that those involved in drug development and trials look for ways to safely involved pregnant women rather than automatically exclude them.”2
Further, the number of “indirect” deaths-deaths unrelated to but exacerbated by pregnancy-among new mothers is on the rise,3 and many surmise that this is due in part to poor medication adherence or physicians’ reluctance to prescribe medications in pregnancy, in either case because of unclear consequences of ingesting the medication while pregnant. For example, one-third of pregnant women stopped taking asthma medication during pregnancy.4,5
One of the challenges with studying a drug’s effect in pregnancy is the length of time in could take for an adverse effect to show up. DTB authors note that “sodium valproate was hailed as a wonder anticonvulsant in the 1960s, linked with neural tube defects in the 1980s and associated with adverse neurodevelopmental effects in the offspring with third trimester exposure in the 2000s.”1 And in addition to complicated ethical, legal, and logistical issues, drug companies are reluctant to invest in the process because the window of pregnancy is so short that it would be unlikely to pay off in additional sales.
Tell us more about your opinion in the comments section below. If you say yes, how would you recommend navigating the legal, ethical, and logistical minefield of testing drugs during pregnancy? If no, why not?
1. Andrade, Susan E., et al. Prescription drug use in pregnancy. AJOG 2004;2: 398-407.
2. Prescribing in pregnancy-therapeutic discrimination? DTB 2013;51:61.
3. Zetstraâvan der Woude, Priscilla A., et al. A population analysis of prescriptions for asthma medications during pregnancy. J Allergy Clin Immunol. 2013;3: 711-717.
4. Ali, Zarqa, Suppli Ulrik, Charlotte. Incidence and risk factors for exacerbations of asthma during pregnancy. J Asthma Allergy. 2013; 6: 53â60.