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Articles tagged with "Drug Safety"

FDA Issues Boxed Warning for Denosumab & Approves a Generic NSAID

Michele B. Kaufman, PharmD, BCGP  |  February 27, 2024

In January, the U.S. Food & Drug Administration approved indomethacin in an oral suspension, a generic version of Indocin Oral Suspension. The agency also issued a boxed warning and updated label for denosumab, warning of the risks of severe hypocalcemia in patients with chronic kidney disease.

Patients on Dialysis Taking Denosumab May Be at Risk of Severe Hypocalcemia

Michele B. Kaufman, PharmD, BCGP  |  December 12, 2022

The FDA is investigating the risk of severe hypocalcemia with serious outcomes, such as hospitalization and death, in patients on dialysis taking denosumab.

A Guiding Light for RA: Insights into Clinical Decision Making, Drug Safety & More

Jason Liebowitz, MD, FACR  |  August 11, 2022

The treatment and management of rheumatoid arthritis (RA) is ever evolving. Here Clifton O. Bingham, MD, discusses the application of RA guidelines, the most recent drug safety information and more.

Health Canada Approves CT-P13 SC for RA; Plus Tofacitinib May Increase Cardiac & Cancer Risks

Michele B. Kaufman, PharmD, BCGP  |  March 5, 2021

In Canada, a subcutaneous formulation of CT-P13, which is biosimilar to infliximab, was approved to treat rheumatoid arthritis.

COVID-19, New Research & More: 2 Experts Discuss Scientific Advances in Rheumatology at ACR Convergence 2020

Catherine Kolonko  |  September 14, 2020

The Year in Review session during ACR Convergence 2020 will address advances in clinical and basic science related to rheumatology, including drug safety, precision medicine, the COVID-19 pandemic and more.

Baricitinib Studied as Possible COVID-19 Treatment; Plus Ranitidine Removed from U.S. Market

Michele B. Kaufman, PharmD, BCGP  |  May 11, 2020

Baricitinib, an oral JAK1/JAK2 inhibitor approved to treat RA in adults, is being investigated as a possible treatment for hospitalized patients with COVID-19…

New Gabapentinoid Warning Labels

Michele B. Kaufman, PharmD, BCGP  |  January 23, 2020

Gabapentinoid products will now carry warning labels about the risks of respiratory distress when combined with opioids and other nervous system and respiratory depressants…

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…

Safety Risk with Higher Dose Tofacitnib

Michele B. Kaufman, PharmD, BCGP  |  March 6, 2019

According to the FDA, an ongoing safety trial found higher dose tofacitinib increased the risks of pulmonary embolism and death in RA patients…

FDA Issues Safety Warning

Michele B. Kaufman, PharmD, BCGP  |  September 25, 2018

The FDA is warning that patients with type 2 diabetes taking SGLT2 inhibitors may be at risk of developing a rare, serious infection, Fournier’s gangrene…

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