Assessment of the Impact of Mandated Postmarketing Pediatric-Focused Safety Reviews on Safety-Related Regulatory Actions 2013-2019.

The US Food and Drug Administration's (FDA's) routine postmarketing drug safety monitoring may lead to safety-related labeling changes for identified risks. Additionally, the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) require the FDA to conduct postmarket pediatric-focused safety reviews of adverse events. The purpose of these pediatric reviews is to identify risks associated with drug or biological products 18 months after the FDA approves a pediatric labeling change pursuant to studies conducted under the BPCA or PREA.

A cohort study to assess risk of cutaneous small vessel vasculitis among users of different oral anticoagulants.

Purpose: Cutaneous small vessel vasculitis (CSVV) was identified as a safety signal among patients treated with direct oral anticoagulants (DOAC). This study aimed to determine if CSVV risk differed among patients with atrial fibrillation (Afib) who newly initiated warfarin or a DOAC.

Methods: We identified enrollees aged ≥21 years diagnosed with Afib who newly initiated rivaroxaban, dabigatran, apixaban, and warfarin in the Sentinel Distributed Database from October 19, 2010 to February 29, 2020.

Acute Hyperkinetic Movement Disorders as a Multifactorial Pharmacodynamic Drug Interaction Between Methylphenidate and Risperidone in Children and Adolescents.

Purpose/background: Acute hyperkinetic movement disorders have been reported with the concomitant use of attention-deficit/hyperactivity disorder (ADHD) stimulants and antipsychotics in children and adolescents. We analyzed postmarketing reports of suspected acute hyperkinetic movement disorder associated with concomitant use of ADHD stimulants and antipsychotics.

Methods/procedures: We searched for postmarketing reports of acute hyperkinetic movement disorders associated with concomitant use of ADHD stimulants-antipsychotics in the US Food and Drug Administration Adverse Event Reporting System through December 6, 2019.

Evaluation of the Inter and Intra-Observer Reliability of the AO Classification of Intertrochanteric Fractures and the Device Choice (DHS, PFNA, and DCS) of Fixations.

Background: ArbeitsgemeinschaftfürOsteosynthesefragen (AO) classification is the most frequently used tool to classify intertrochanteric fractures. However, there is limited evidence regarding its reliability. Therefore, this study was designed to evaluate inter-observer and intra-observer reliability of the AO-2018 intertrochanteric fracture classification.

Complementary Use of U.S. FDA's Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants-Associated Cutaneous Small Vessel Vasculitis.

Background: Cutaneous small vessel vasculitis (CSVV) has been reported after exposure to direct oral anticoagulants (DOACs), such as dabigatran, rivaroxaban, apixaban, and edoxaban.

Objective: We used the U.S.

Health Status and Health Care Needs of Drought-Related Migrants in the Horn of Africa-A Qualitative Investigation.

Somalia, Kenya and Ethiopia, situated in the Horn of Africa, are highly vulnerable to climate change, which manifests itself through increasing temperatures, erratic rains and prolonged droughts. Millions of people have to flee from droughts or floods either as cross-border refugees or as internally displaced persons (IDPs). The aim of this study was to identify knowledge status and gaps regarding public health consequences of large-scale displacement in these countries.

Concomitant use of buprenorphine for medication-assisted treatment of opioid use disorder and benzodiazepines: Using the prescription behavior surveillance system.

Background: Despite clinical guidelines discouraging the practice, it is well-documented that the concomitant use of benzodiazepines and opioid analgesics occurs regularly. Information on concomitant use of buprenorphine for medication-assisted treatment (MAT) of opioid use disorder (OUD) and benzodiazepines, however, is limited. Thus, we aimed to describe real-world drug dispensing patterns for the concomitant use of buprenorphine products approved for MAT and benzodiazepines.

Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer's Capture of Spontaneous Reports for Exposed Pregnancies.

Introduction: Pregnancy registries and spontaneous reports are essential pharmacovigilance tools to evaluate drug safety during pregnancy.

Objectives: The aim of this study was to evaluate postmarket capture of exposed pregnancies.

Methods: Pregnancy registries for drugs and biologics were identified in a systematic review.