Key Points Question What is the current state of US Food and Drug Administration labeling of medications in relation to pregnancy and lactation? Findings In this cross-sectional study of 290 newly approved medications from January 2010 to December 2019, all products submitted after June 20, 2015, were in compliance with the Pregnancy and Lactation Labeling Rule (PLLR); however, of those submitted between 2010 and 2015, 32.6% were not in PLLR format by the designated date of June 30, 2019. Human data on pregnancy and lactation were available in less than 20% of new product labeling. Meaning This study found that with the implementation of PLLR in the last decade, new therapeutic products are in compliance with the new rule; however, more than one-third of labels remain out of PLLR compliance.

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OBJECTIVE: To evaluate the association of increasing body mass index (BMI) on postpartum tubal ligation safety and estimate the rates of procedure complication. METHODS: We conducted a single-institution, retrospective review. Women undergoing postpartum permanent contraception after vaginal delivery from August 2015 to March 2019 were studied. Our primary outcome included a composite morbidity of intraoperative complications (bleeding requiring additional surgery, and extension of incision), blood transfusion, aborted procedure, anesthetic complication, readmission, wound infection, venous thromboembolism, ileus or small bowel obstruction, incomplete transection, and subsequent pregnancy. Statistical analysis included t test, χ2 test, and Wilcoxon rank-sum test, with P<0.05 considered significant. RESULTS: During the study period, 3,670 women were studied: 263 were underweight or normal weight (BMI 24.9 or lower), 1,044 were overweight (25–29.9), 1,371 had class I obesity (30–34.9), 689 had class II obesity (35–39.9), and 303 had class III obesity (40 or higher) at the time of admission. Composite morbidity occurred in 49 cases (1.3%) and was not significantly different across the BMI categories (P=.07). Twelve cases of incomplete transection were noted on pathology reports; however, none of these accounted for the six subsequent pregnancies that were identified. There were no deaths or events leading to death noted in the study population. The length of time to complete the procedure increased across BMI categories (23 minutes in women with normal weight, and 31 in women with class III obesity) (P<.001). CONCLUSION: There was no association between increased BMI and morbidity with women undergoing postpartum tubal ligation. Postpartum tubal ligation should be considered a safe and reasonable option for women, regardless of BMI.

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