Early Detection and Surveillance of the SARS-CoV-2 Variant BA.2.86 - Worldwide, July-October 2023.

Early detection of emerging SARS-CoV-2 variants is critical to guiding rapid risk assessments, providing clear and timely communication messages, and coordinating public health action. CDC identifies and monitors novel SARS-CoV-2 variants through diverse surveillance approaches, including genomic, wastewater, traveler-based, and digital public health surveillance (e.g., global data repositories, news, and social media). The SARS-CoV-2 variant BA.2.86 was first sequenced in Israel and reported on August 13, 2023. The first U.S. COVID-19 case caused by this variant was reported on August 17, 2023, after a patient received testing for SARS-CoV-2 at a health care facility on August 3. In the following month, eight additional U.S. states detected BA.2.86 across various surveillance systems, including specimens from health care settings, wastewater surveillance, and traveler-based genomic surveillance. As of October 23, 2023, sequences have been reported from at least 32 countries. Continued variant tracking and further evidence are needed to evaluate the full public health impact of BA.2.86. Timely genomic sequence submissions to global public databases aided early detection of BA.2.86 despite the decline in the number of specimens being sequenced during the past year. This report describes how multicomponent surveillance and genomic sequencing were used in real time to track the emergence and transmission of the BA.2.86 variant. This surveillance approach provides valuable information regarding implementing and sustaining comprehensive surveillance not only for novel SARS-CoV-2 variants but also for future pathogen threats.

Behaviors Related to Medication Safety and Use During Pregnancy.

Background: Most women take medication during pregnancy despite limited scientific evidence on safety. We investigated medication use, including changes in and reasons for changes in use during pregnancy, with attention to medication use in pregnant women with chronic conditions. Materials and Methods: We conducted an online survey of pregnant women aged ≥18 years (n = 1,226). We calculated descriptive statistics for aspects of medication use and performed multivariable logistic regression to examine associations between change in use and chronic conditions. Results: Seventy-nine percent of women took at least one medication during pregnancy. Among those, 63.2% made at least one medication change: 42.0% started, 34.9% stopped, 30.0% missed dose(s), and 18.1% lowered dose(s) from that originally prescribed or recommended. More than a third (36.5%) of women who stopped, lowered, or missed medication did so independent of health care provider advice; 54.0% cited concern about birth or developmental defects as reasons for change. Odds of medication change were higher for women with chronic conditions: digestive conditions-starting (adjusted odds ratio [AOR] = 1.8, 95% confidence interval [CI] = 1.1-2.7), stopping (AOR = 2.1, 95% CI = 1.4-3.3), and lowering (AOR = 2.4, 95% CI = 1.7-3.3) medication; mental health conditions-starting (AOR = 1.6, 95% CI = 1.2-2.2), stopping (AOR = 3.0, 95% CI = 2.3-4.0), or missing (AOR = 2.1, 95% CI = 1.6-2.8) medication; pain conditions-stopping (AOR = 2.9, 95% CI = 2.0-4.2); and respiratory conditions-starting (AOR = 2.0, 95% CI = 1.3-3.1), stopping (AOR = 1.7, 95% CI = 1.1-2.6), and missing (AOR = 2.2, 95% CI = 1.4-3.4) medication. Conclusions: Most pregnant women take medication and many, including those with chronic conditions, change their medication use during pregnancy. Medication change may occur independent of health care provider advice and due to women's safety concerns.

Determinants of Hormone Replacement Therapy Knowledge and Current Hormone Replacement Therapy Use.

Background: The use of hormone replacement therapy (HRT) to treat menopausal symptoms has declined since the early 2000s, and little is known about the contemporary determinants of use in the United States. We aim to understand women's knowledge of HRT as a treatment of menopausal symptoms and to assess the factors associated with HRT use. Materials and Methods: Weighted multivariate logistic regression models evaluated the correlates of high HRT knowledge and current HRT use among a sample of 2,548 women aged ≥45 years who participated in an online survey between August 2019 and May 2020. Results: In total, 82% of the women surveyed reported experiencing one or more menopausal symptoms, yet only 10.5% reported using HRT. Only 33% reported high HRT knowledge. The odds of reporting high HRT knowledge increased with increasing age. Racial, ethnic minority women were less likely to report high HRT knowledge (adjusted odds ratio [AOR] = 0.69; 95% confidence interval [CI] = 0.5-0.9). Hispanic and non-Hispanic women of other racial and ethnic groups were less likely to use HRT compared with non-Hispanic White women (AOR = 0.3; 95% CI = 0.1-0.6) (AOR = 0.4; CI = 0.2-0.9), respectively. Women experiencing irregular periods were less likely to report current HRT use (AOR = 0.1, 95% CI = 0.4-0.7). Compared with past users, never users appeared to be more risk averse, and reported concern over HRT risks and side effects as reasons for nonuse. Conclusions: Many factors impact women's perceived HRT knowledge level and to a lesser extent HRT use. Future research should better define the most important factors influencing decisions to use HRT for symptom relief.

Food and Drug Administration Beyond the 2001 Government Accountability Office Report: Promoting Drug Safety for Women.

A 2001 U.S. Government Accountability Office (GAO) report indicated 8 of 10 drugs withdrawn from the U.S. market between 1997 and 2000 posed greater risk to women than men. We examined drugs withdrawn from the market for safety-related reasons from January 1, 2001, to January 1, 2018. To be included, drugs must be listed as discontinued on Drugs@FDA and either listed in the Federal Register or cited in literature as being withdrawn for safety-related reasons. Biologics, over-the-counter products, and medical devices were excluded. During the 17-year time span, 19 drugs were withdrawn from the market for safety-related reasons, fewer drugs per year compared to the 3-year period examined in the GAO report. Food and Drug Administration (FDA) has not recommended the market removal of any drug approved since 2005 due to the time from the start of the Q wave to the end of the T wave (QT) interval prolongation resulting in torsades de pointes (TdP) or other abnormal heart rhythms. Furthermore, no drugs approved after the implementation of FDA's 2009 guidance on drug-induced liver injury (DILI) have been withdrawn because of hepatoxicity. All, but one of the drugs discontinued from the market for safety-related reasons during the period examined were approved between 1957 and 2002. TdP and DILI are two relevant examples of drug-induced adverse events posing greater risk to women than men. FDA has made measurable progress incorporating consideration of sex and gender differences into drug trial development and FDA review of these data, supporting inclusion of women in clinical trials, providing a comprehensive drug safety review, and advancing postmarket surveillance and risk assessment, thus strengthening FDA's ability to protect public health.