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Articles tagged with "Safety"

15,000 Patient-Years: Safety Data for Upadacitinib Treatment Across Multiple Rheumatic Conditions

Michele B. Kaufman, PharmD, BCGP  |  October 17, 2024

Burmester et al. characterized the long-term safety profile of upadacitinib treatment across multiple rheumatic diseases.

Without Fear: Psychological Safety for Learners & Patients

Jason Liebowitz, MD, FACR  |  June 18, 2022

Constructing a safe space for reporting errors is important & enables medical trainees to grow, making them better learners and scholars, and faculty members and patients to express their concerns. During a session at the 2022 ACR Education Exchange, Karina Torralba, MD, MACM, RhMSUS, provided insights into how to manage the barriers to fostering such a workplace culture.

FDA Updates Boxed Warning of Benzodiazepines, Adding Risks for Abuse & Addiction

Michele B. Kaufman, PharmD, BCGP  |  October 7, 2020

The FDA is requiring all benzodiazepines to carry an updated boxed warning that addresses the risks of misuse, abuse and addiction associated with their use.

How to Create a Safe Practice & Prep for a COVID-19 Resurgence

Steven M. Harris, Esq.  |  August 12, 2020

For many months, the healthcare world has been significantly affected by the swift and per­vasive effects of SARS-CoV-2, which causes COVID-19. The virus has severely affected the delivery of patient care by all providers, including those in hospitals and emergency care settings, who grappled with the response to massive influxes of COVID-19 patients, and those…

For Psoriasis, Ustekinumab & TNF Inhibitors Show Similar Cardiac Safety

David Douglas  |  April 9, 2019

NEW YORK (Reuters Health)—In patients with psoriasis and psoriatic arthritis, the incidence of atrial fibrillation and major adverse cardiovascular events does not differ between treatment with ustekinumab and TNF inhibitors, according to a large observational study. “Given a high cardiovascular risk among patients with psoriasis and psoriatic arthritis,” Seoyoung C. Kim, MD, ScD, MSCE, told…

FDA Issues Boxed Warning for Febuxostat & Approves Colchicine for Gout Flare

Michele B. Kaufman, PharmD, BCGP  |  March 12, 2019

The FDA has issued a boxed warning for febuxostat after a safety study found an increased risk of heart-related and other death in RA patients…

FDA Expands Safety Measures for Immediate Release Opioids

Michele B. Kaufman, PharmD, BCGP  |  October 2, 2018

The FDA has expanded the new Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) to include immediate release opioids. The program, which also includes extended release and long acting opioids, will provide education to prescribers and healthcare professionals…

EU Grants Marketing Authorization for Hyrimoz; Plus FDA Rejects New Drug Application for Buprenorphine Sublingual Spray

Michele B. Kaufman, PharmD, BCGP  |  August 8, 2018

In late July, the European Commission granted marketing approval for Hyrimoz, which is biosimilar to adalimumab…

FDA Receives Reports of Loperamide Abuse

Michele B. Kaufman, PharmD, BCGP  |  February 14, 2018

The FDA is seeking to limit the number of loperamide doses per package due to reports of heart-related problems and death from the misuse and abuse of the treatment…

Rheumatology Drug Updates: Hip Fracture Rates After Bisphosphonate Drug Holidays, Plus More on Golimumab, Ustekinumab

Michele B. Kaufman, PharmD, BCGP  |  December 19, 2017

Bisphosphonate Drug Holidays Drug holidays are common for patients on bisphosphonate therapy. Often, these breaks in treatment are related to known U.S. Food and Drug Administration (FDA) warnings and drug class adverse effects. Currently, data on fracture risk related to drug holidays are limited. In recent research highlighted at the 2017 ACR/ARHP Annual Meeting ,…

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