Beginning in 2015, the FDA revised the labeling system, which now offers more descriptive, up-to-date and well-organized information about a medication’s risks to the expectant mother, the developing fetus and the breastfed infant. A new label subsection was also created to address relevant information about pregnancy testing, birth control and a medication’s effect on the fertility of both women and men. Using this information, as well as the Drugs and Lactation Database (LactMed), maintained by the U.S. National Library of Medicine, rheumatologists can better counsel patients on which medications are safe to use during pregnancy and breastfeeding, and which should be discontinued prior to a planned pregnancy.3
Example: The updated labeling indicates that aspirin is safe to use during pregnancy. In 2018, the American College of Obstetricians (ACOG) released a committee opinion advising that women at increased risk of pre-eclampsia—which includes all lupus patients—be prescribed low-dose aspirin (81 mg daily) as a prophylactic measure between 12 and 28 weeks’ gestation.4 Despite this recommendation, a 2019 study of 475 pregnancies in lupus patients showed aspirin prophylaxis was used in only 25% of pregnancies.5 This and other examples of the underuse of appropriate medications in pregnant lupus patients indicates the ongoing need for provider education about this subject, Dr. Bermas noted.
Patient Communication
The final speaker was Megan Clowse, MD, MPH, associate professor of medicine, rheumatology and immunology at Duke University, Durham, N.C. Dr. Clowse discussed the HOP-STEP program, which stands for Healthy Outcomes in Pregnancy with SLE Through Education of Providers. With an easy-to-navigate website and series of printable handouts, the HOP-STEP program is designed to help start productive conversations between rheumatologists and SLE patients about how best to achieve healthy pregnancies.
Dr. Clowse noted the most effective way to begin this conversation is with the open-ended question: “Would you like to become pregnant in the next year?” Based on the discussion that follows, the program’s Preparing for Pregnancy handout is designed to guide providers and patients through a series of checklists that include reviewing which medications are safe during pregnancy and the patient’s current level of disease activity. The handout also addresses identifying key specialists who may play a role in the patient’s care before, during and after pregnancy, and planning the management of specific medical issues, such as antiphospholipid antibody syndrome, hypertension and screening for neonatal lupus in patients with Ro/SSA antibodies.
The website also includes video interviews with lupus patients who discuss their experiences with pregnancy, their views on family planning and their expectations for how best to have supportive and healthy discussions about these topics with their providers.