FDA OWH newsletter – November 2023: Understanding Pregnancy Registries

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Message from the Associate Commissioner

Dear Women’s Health Colleagues, 

Each year in the United States there are about 6 million pregnancies, and 80% of those who are pregnant say that they take at least one medicine during pregnancy. Some may be getting treatment for a health problem they had before pregnancy, while others take medicines for health conditions such as diabetes and high blood pressure, which can develop or worsen during pregnancy. 

If you are pregnant and taking medicines or vaccines—or treating patients who are—we invite you to learn more about pregnancy exposure registries. Pregnancy exposure registries are voluntary research studies that collect information about the effects of prescription medicines taken, or vaccines received during pregnancy. Information collected can help health care providers and others who are pregnant learn more about the safety of medicines and vaccines used during pregnancy.

Please take a moment to watch this new video from the FDA Office of Women’s Health (OWH) and visit our pregnancy exposure registries webpage to learn more and find a list of registries. We also invite you to read and share our latest Knowledge and News on Women’s Health (KNOWH) blog, which provides an introduction to pregnancy registries for patients and health care providers, and view our public continuing education webinar, Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation.

Sincerely,

Kaveeta P. Vasisht, M.D., Pharm.D.

Associate Commissioner for Women’s Health
Director, Office of Women’s Health (OWH)

Read and share our caregiver resources!

November is National Family Caregivers Month, and we honor the many caregivers across our communities who are caring for their family and friends. While it can be a rewarding experience for many, caregiving can also be challenging.  

A common challenge can include caregiver stress and women especially are at risk for the harmful health effects of caregiver stress. FDA OWH has resources to help you manage your loved one’s medical needs while also taking care of yourself. 

Women’s health news and updates

• FDA Grants Marketing Authorization of First Test for Chlamydia and Gonorrhea with at-home Sample Collection
• Federal Court Enters Consent Decree Against Arizona-based Company for Distribution of Unapproved Contraceptive Drugs
• Labeling Updates for BD Mesh Products – Letter to Health Care Providers
• Pregnant? Breastfeeding? FDA Aims to Improve Drug Information
• FDA Office of Women’s Health - The Power of STEM (National STEM Day Video)
• FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants
• It’s a good time to get your flu vaccine (Also see: COVID-19, Flu and RSV: FDA Resources for the Fall Respiratory Illness Season)

More updates from around FDA

• FDA Clears First COVID-19 Home Antigen Test
• FDA Approves New Medication for Chronic Weight Management
• FDA Celebrates National STEM Day 
• Do Not Use Certain Brands of Saline and Sterile Water Medical Products by Nurse Assist Because They May Not Be Sterile: FDA Safety Communication
• FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection
• FDA Advises Parents and Caregivers Not to Buy or Feed WanaBana Apple Cinnamon Fruit Puree Pouches to Toddlers and Young Children Because of Elevated Lead Levels
• FDA Proposes to Ban Food Additive, Continues Assessments of Additional Chemicals
• National Survey Shows Drop in E-Cigarette Use Among High School Students
• FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases
• FDA approves toripalimab-tpzi for nasopharyngeal carcinoma
• FDA Approves New Therapy for Rare Form of Blood Cancers Called Myelodysplastic Syndromes

Pregnancy exposure registries are studies that collect health information on exposure to medical products such as drugs and vaccines during pregnancy.  Learn more about pregnancy registries today!

• November 28-29 - UGA/FDA 10th Annual Medical Device Regulations Conference
• November 29-30 - Public Workshop: Discussing Approaches to Enhance Clinical Study Diversity
• November 30 - FDA Oncology Center of Excellence (OCE) Conversations on Cancer: How Biotech Built a Blockbuster Cancer Drug

Visit FDA Meetings, Conferences and Workshops to find out about available meetings.