Message from the Associate Commissioner
Dear Women’s Health Colleagues,
Last week, the U.S. Food and Drug Administration granted marketing authorization to NOWDiagnostics for the First To Know Syphilis Test. Syphilis is a sexually transmitted infection (STI) that can cause serious health problems such as cardiovascular and neurological disorders if left untreated. This is the first at-home, over-the-counter test to detect Treponema pallidum (syphilis) antibodies in human blood.
Results from this type of test alone are not sufficient to diagnose syphilis infection and should be followed by consultation with a health care provider and additional testing to confirm a diagnosis of syphilis.
According to the Centers for Disease Control and Prevention (CDC), syphilis cases in the United States increased by nearly 80% between 2018 and 2022. For pregnant women, syphilis is particularly dangerous as it can be transmitted to the fetus, and can cause stillbirth, low birth weight, congenital syphilis, and a range of serious health issues for the newborn. The impact of congenital syphilis highlights the critical importance of prenatal care. Routine syphilis screening during pregnancy is essential for early detection and treatment of syphilis, which can prevent complications and reduce the spread of syphilis.
This availability of the at-home testing can help inform patients about a potential syphilis infection and ultimately may help curb the rising rates of syphilis. It is important to note that results of the at-home test will be positive for individuals previously diagnosed with syphilis, even if they were successfully treated. Results of the test alone should not be used to start, stop, or change any treatments. Talk with your health care provider about your test results, and whether treatment is needed.
 Please take the opportunity to learn more about syphilis and congenital syphilis by reading this edition of our Knowledge and News on Women’s Health (KNOWH) blog. Additionally, OWH hosted a Speaker Series lecture titled: Sexually Transmitted Infections in Women featuring Dr. Khalil Ghanem, Professor of Medicine in the Division of Infectious Diseases at Johns Hopkins University School of Medicine. The lecture reviewed the epidemiology, clinical presentation, diagnostic approach, and treatment of the common and curable sexually transmitted infections in women. Furthermore, the lecture highlighted important gaps in knowledge that, if filled, can help enhance reproductive health outcomes. I encourage you to watch the recording for more information.
Sincerely,
Kaveeta P. Vasisht, M.D., Pharm.D.
Associate Commissioner for Women’s Health
Director, Office of Women’s Health (OWH)
  August is Breastfeeding Awareness Month, an annual observance designed to promote the benefits of breastfeeding. According to the CDC, breastfeeding is the best source of nutrition for most infants. While the decision to breastfeed may look different for everyone, it is important to know the facts—as there are benefits for both the breastfeeding parent and the baby.
Did you know that breast pumps—devices often used by breastfeeding women to extract (“express”) their breast milk—are medical devices regulated by the FDA? Learn more about how to safely use a breast pump and store breast milk.
OWH recognizes that breastfeeding may not be possible for everyone for various reasons. Many infants in the U.S. rely on infant formula for some or all their nutrition. Learn more about handling infant formula safely.
  National Immunization Awareness Month is an annual observance held in August to highlight the importance of vaccination for people of all ages. From babies to adults, people need vaccines to protect them from potentially dangerous infectious diseases. Without vaccines, children and adults are at risk for serious illness and even death from vaccine preventable diseases. Ensuring the safety and effectiveness of vaccines used in the U.S. is one of the FDA’s top priorities. Here are the facts on vaccines.
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