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INTRODUCTION: Brodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Although the US prescribing information for brodalumab includes a boxed warning regarding suicidal ideation and behavior, no causal association has been demonstrated. Here, we summarize 5 years of pharmacovigilance data, from August 15, 2017, through August 14, 2022, reported to Ortho Dermatologics by US patients and healthcare providers. METHODS: Prevalence of the most common adverse events (AEs) listed in the brodalumab package insert (incidence ≥ 1%) and AEs of special interest are described. Brodalumab exposure was estimated as the time from the first to last prescription-dispensing authorization dates. Data were collected from 4744 patients in the USA, with an estimated exposure of 5815 patient-years. RESULTS: Over 5 years, 11 cases of adjudicated major adverse cardiovascular events were reported (0.23 events/100 patients), a rate lower than that experienced by patients in the international Psoriasis Longitudinal Assessment and Registry. There were 106 serious infections. No serious fungal infections were reported. There were 40 confirmed and 2 suspected COVID-19 cases, with no new COVID-19-related deaths. Of 49 reported malignancies among 42 patients, 3 were deemed possibly related to brodalumab. No completed suicides and no new suicidal attempts were reported. CONCLUSION: Five-year pharmacovigilance data are consistent with the established safety profile reported in long-term clinical trials and previous pharmacovigilance reports, with no new safety signals.

* Objectives. - To describe demographic and medical characteristics of a sample of children younger than age 3 years who required lengthy hospitalization in a tertiary care hospital. To determine the proportion of children in the sample with biologic handicaps, developmental delays, or risk factors for developmental disorders who met eligibility criteria for early intervention services based on federal law PL 99-457 and state regulations. Design. - Survey of medical records. Setting. - Large, urban, tertiary care children's hospital. Patients. - All 135 children younger than age 3 years hospitalized for more than 30 days during 1990 and 1991. Interventions. - None. Main Results. - The most prevalent cause of lengthy hospitalization was congenital anomaly followed by chronic and perinatal conditions; 38 patients (28%) required technology assistance at the time of discharge. Seventy-three children (54%) were eligible for early intervention services based on the presence of a biologic handicap or developmental delay. An additional 48 patients (36%) were eligible for developmental screening and periodic developmental monitoring on the basis of medical and social risk factors. Conclusions. - Because of the high prevalence of developmental disorders and risk factors in infants and toddlers requiring lengthy hospitalizations, hospital-wide systems for identification, developmental assessment, and early intervention services should be designed and implemented. (AJDC 1993;147:211-215), Hospitals should implement programs to detect and address developmental disorders among infants and children hospitalized for long periods of time. While the risks of developmental disorders among premature infants are known and many programs have been installed to meet their needs, the developmental needs of hospitalized children outside of neonatal intensive care units (NICU) often go unrecognized. Of 135 children who were hospitalized for longer than 30 days in a Pennsylvania hospital, 85% had multisystem diseases, and 46% had birth defects. Fifty-four percent were eligible for early intervention services in Pennsylvania, and 36% were eligible for identification, screening and tracking due to medical or social risk factors. Overall, 90% were eligible for some developmental service. Identifying children outside of NICUs who need developmental services will require cooperation among pediatricians, nurses and administration but is critical given the high incidence of disorders among children with lengthy hospital stays.

Abstract Background Microvascular and macrovascular complications in diabetes stem from chronic hyperglycemia and are thought to have overlapping pathophysiology. The aim of this study was to investigate the incidence rate of hospitalized myocardial infarctions (MI) and cerebrovascular accidents (CVA) in patients with diabetic macular edema (DME) compared with diabetic patients without retinal diseases. Methods This was a retrospective cohort study of a commercially insured population in an administrative claims database. DME subjects (n = 3519) and diabetes controls without retinal disease (n = 10557) were matched by age and gender. Healthcare claims were analyzed for the study period from 1 January 2002 to 31 December 2005. Incidence and adjusted rate ratios of hospitalized MI and CVA events were then calculated. Results The adjusted rate ratio for MI was 2.50 (95% CI: 1.83-3.41, p Conclusion Event rates of MI or CVA were higher in patients with DME than in diabetes controls. This study is one of few with sufficient sample size to accurately estimate the relationship between DME and cardiovascular outcomes.

Presents letters to the editor on medical topics as of February 6, 2002. Decisions about cervical spine radiography following trauma; Cost-effectiveness of aircraft safety measures; Public education about the risks of the drug ecstasy; Dry eye syndrome in post-menopausal women; Responsibility of physicians and pharmacists in preventing drug interactions; Others.