Adverse event profile of CGRP monoclonal antibodies: findings from the FDA adverse event reporting database.

BACKGROUND: Four CGRP Monoclonal Antibodies (mAbs) have been approved for migraine prophylaxis by the Food and Drug Administration (FDA) since 2018. However, there are concerns about the safety of these four drugs for real-world use. OBJECTIVE: To compare the adverse event profiles of four CGRP-mAbs with FAERS data. METHODS: The study was based on records from the FAERS database. Only reports containing one of the active ingredients with CGRP-mAbs were included in this study. Disproportionality analyses including but not limited to reporting odds ratio (ROR) and information components (IC) were conducted to identify drug-AE associations. RESULTS: In total, 58110 reports were identified for CGRP-mAbs. 80 overlapping signals were disproportionately reported. They affected a range of organs and systems, including the gastrointestinal and cardiovascular systems, skin, and hair. Additionally, the rare cardiovascular adverse events were significantly different among the four CGRP-mAbs. CONCLUSION: We identified numerous shared underlying signals (overlapping signals) for CGRP-mAbs as suspected drugs in multiple systems and organs. The unlabeled common signals may indicate potential safety issues. In addition, the underlying safety signals varied among the four CGRP-mAbs, particularly in the cardiovascular system, and further studies are needed to confirm these associations and the potential clinical implications.

Association between vitamin K intake and depressive symptoms in US adults: Data from the National Health and Nutrition Examination Survey (NHANES) 2013-2018.

Background: The relationship between vitamin intake and depression has attracted increasing attention. However, several studies examining such relationship among populations at different age groups have produced inconsistent findings. This study was aimed to investigate the cross-sectional association between vitamin K intake and depressive symptoms in US adults. Methods: We used the data from a nationally representative sample of 11,687 adults from the 2013 to 2018 National Health and Nutrition Examination Survey (NHANES). Vitamin K intake was assessed by the 24-h dietary recall at the first day. Depressive symptoms were assessed using the 9-item Patient Health Questionnaire (PHQ-9). Logistic regression and generalized additive model were used to examine the association between vitamin K intake and depressive symptoms. Results: The weighted prevalence of depressive symptoms was 10.2% (8.0% in men and 12.0% in women). We observed a significant inverse linear relationship between vitamin K intake and depressive symptoms in models adjusted for age, sex, race/ethnicity, marital status, educational status, family poverty income ratio (PIR), home status, body mass index (BMI), smoking status, physical activity, sleep disorders, hypertension, hyperlipidemia, and diabetes. The odds ratios (OR) (95% CI) for the highest compared with the lowest quartile of vitamin K intake was 0.68 (95% CI: 0.52, 0.89, p-trend < 0.05). The association was similar in subgroups stratified by age, sex, race/ethnicity, marital status, educational status, PIR, home status, BMI, smoking status, physical activity, sleep disorders, hypertension, hyperlipidemia, and diabetes. Conclusion: Vitamin K intake was inversely and independently associated with the odds of depressive symptoms in the US adults. Prospective studies are warranted to confirm our findings.