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Introduction A potentially elevated risk for pulmonary thrombosis with Janus kinase inhibitors (JAKinibs) was identified, as well as an increased risk for portal vein thrombosis, in ruxolitinib patients. Consequently, the objective of this investigation was to repeat a comprehensive analysis of the US FDA’s Adverse Event Reporting System (FAERS) database to assess postmarketing reporting rates of thromboembolic events (TEs) in patients treated with JAKinibs. Methods FAERS data (1 January 2010 to 30 September 2019) were searched for reports of all FDA-approved JAKinibs across all indications. For each drug–adverse drug reaction (ADR) pair, the reporting odds ratio (ROR) [two-sided 95% confidence interval (CI)] and empirical Bayesian geometric mean (EBGM) [one-sided 95% lower bound] were calculated to detect drug–ADR pairs with higher-than-expected reporting rates within the FAERS. Significance was declared when both lower 95% CI bounds were > 1. Results Significantly elevated reporting rates of pulmonary thrombosis were evident with tofacitinib (ROR 2.36 [1.69–3.31]; EBGM 2.01 [1.53]), as was pulmonary embolism with baricitinib (ROR 12.23 [8.35–17.89]; EBGM 7.72 [3.82]) and portal vein thrombosis with ruxolitinib (ROR 4.16 [2.70–6.40]; EBGM 4.52 [3.11]). Deep vein thrombosis reports were increased with baricitinib (ROR 14.84 [9.64–22.84]; EBGM 9.49 [5.91]), as was thrombosis with ruxolitinib (ROR 1.40 [1.20–1.63]; EBGM 1.72 [1.52]). The relationship between the time of treatment initiation and event occurrence indicated that time to events occurred randomly. Conclusions This study found significant reporting rates for TEs in patients treated with JAKinibs across brands and indications, providing additional evidence that JAKinibs may be contraindicated in patients at risk of TEs. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-021-01082-y.

Inflammatory bowel diseases (IBD) include ulcerative colitis and Crohn’s disease. These conditions commonly affect patients during their childbearing years. There are many questions that arise when a female patient with inflammatory bowel disease is attempting pregnancy. Important considerations include the safety of continuing medications during and after pregnancy, the risk of stopping drugs during pregnancy, and the effects of the medications on the newborn. Most pharmacologic agents are safe to continue during pregnancy; however, some drugs such as methotrexate are contraindicated. The anti-tumor necrosis factor biologic agents infliximab and adalimumab have the most robust data regarding their safe use in pregnancy and while breastfeeding. More experience is needed with newer medications. Another important question that can often arise is the potential effect that IBD can have on fertility. Patients with IBD who have not undergone surgery have fertility rates similar to those patients without IBD, though voluntary childlessness is higher in those patients with IBD. Female patients who have undergone surgery for their IBD, such as total colectomy with creation of an ileal pouch-anal anastomosis (IPAA), do have decreased fertility rates compared to those patients without IBD.