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AAFA's Experts Help FDA and NIH Address Safety of Asthma Medications During Pregnancy and Lactation

 

Asthma is one of the most common medical problems that occurs during pregnancy. It can be potentially serious. Asthma can get worse during pregnancy and lead to problems like high blood pressure, early labor and delivery, and low birth weight. Asthma can even cause death.

The Centers for Disease Control and Prevention (CDC) tracks pregnancy-related deaths (from any cause) in the United States in a system called the Pregnancy Mortality Surveillance System (PMSS). The rate of maternal deaths has been rising. Black and American Indian or Alaska Native women are at highest risk. These groups are also at highest risk for asthma complications.

Asthma treatment and control requires the use of medicines. Mother and baby need oxygen to live. But because pregnant women are excluded from clinical trials, there are questions about the safety of medicine use while pregnant or lactating. It is important for women to feel comfort with their treatment so they can manage their asthma effectively.

The Asthma and Allergy Foundation of America (AAFA) is a key stakeholder in a workgroup that includes the Food and Drug Administration (FDA), the National Heart Lung Blood Institute (NHLBI), and the National Institutes of Health. The group includes experts from across the United States who specialize in women’s health, pregnancy, prenatal care or asthma. The group held a workshop in November 2019 to address women’s asthma health during pregnancy and lactation.

The aim of the group is to identify action steps on gaps in knowledge regarding asthma medication safety in pregnancy and lactation. The Journal of Allergy and Clinical Immunology (JACI) published a summary of the workshop proceedings this week:

The Safety of Asthma Medications During Pregnancy and Lactation: Clinical Management and Research Priorities

  • The stakeholders identified substantial gaps in the literature on the safety of asthma medications used during pregnancy and lactation and prioritized strategies to fill those gaps.
  • Short-term action steps included linking data (U.S. and international claims data, single drug pregnancy registries, case-control studies, and coordinated systematic data systems).
  • Long-term action steps included creating an asthma disease registry, incorporating the disease registry into electronic health record systems, and coordinating care across disciplines.
  • The stakeholders also prioritized establishing new infrastructures/collaborations to perform research in pregnant and lactating women and to include patient perspectives throughout the process.
  • In order to address the evidence gaps, and aid in populating product labels with data that informs clinical decision making, the group developed a plan to systematically obtain necessary data in the most efficient and timely manner.


Dr. Richard Murray, AAFA’s board chair and a pulmonologist, Melanie Carver, AAFA’s Chief Mission Officer, and Lorene Alba, AAFA’s Director of Education and a certified asthma educator, are part of the workgroup and co-authors of the journal article.

The workgroup is led by Christina Chambers, PhD, MPH, a world‐renowned perinatal epidemiologist and a Professor of Pediatrics and Family and Preventive Medicine at the University of California San Diego. Dr. Chambers is also the lead investigator for MotherToBaby Pregnancy Studies that are looking at the effects of asthma in pregnancy. More information is available at MothertoBaby.org.

The American Academy of Allergy, Asthma & Immunology (AAAAI) is also a part of this workgroup. The AAAAI facilitates the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS), which monitors the use and safety of vaccines and medications during pregnancy.

AAFA was the only organization involved to represent the voice of the patient. AAFA advocated that patient perspectives and concerns are considered in all aspects of clinical trials. Including trained and diverse patient advisors can increase participant’s comfort level with the research process as well as increase knowledge of their health condition.

AAFA is committed to improving maternal asthma health and will continue to participate in this important work to advance drug safety. AAFA has also received funding from the CDC to expand education and support services to help moms manage and control their asthma. The grant is funding AAFA’s Community Health Interventions to Advance Self-Management of Asthma project. To receive updates as AAFA’s programs to support pregnant women become available, join AAFA’s online community.

To learn more about how asthma impacts pregnancy, visit AAFA’s Asthma During Pregnancy resource page.

AAFA Supports Bills Aimed at Saving and Improving the Lives of Black Mothers

AAFA is proud to support the Black Maternal Health Momnibus Act with the goal of ending maternal deaths and closing racial and ethnic disparities in maternal health outcomes.

Ask your representative to support the Black Maternal Health Momnibus Act.

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