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.

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A 2001 U.S. Government Accountability Office (GAO) report indicated 8 of 10 drugs withdrawn from the U.S. market between 1997 and 2000 posed greater risk to women than men. We examined drugs withdrawn from the market for safety-related reasons from January 1, 2001, to January 1, 2018.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.