FDA to Review Abuse-Deterrent Oxycodone Capsule In June, the FDA will discuss the New Drug Application for Remoxy ER at an Advisory Committee meeting. Remoxy ER is a 12-hour, abuse-deterrent, extended-release oxycodone in a capsule formulation.1 The capsule contains a sticky, thick, high-viscosity formulation to deter unapproved drug administration routes, including injection, smoking or snorting….
After an independent review, ongoing clinical trials investigating the safety of fasinumab for treating hip or knee OA will discontinue the use of higher fasinumab doses…
NEW YORK (Reuters Health)—Risk of myocardial infarction (MI) is increased in patients with spondyloarthritis (SpA) who use the nonsteroidal anti-inflammatory drug (NSAID) diclofenac, but not in those who take naproxen, researchers say. Maureen Dubreuil, MD, MSc, of Boston University School of Medicine, and colleagues analyzed 20 years of medical records from the U.K.’s Health Improvement…
A recent study examined how often patients exceed the dosing limits of nonsteroidal anti-inflammatory drugs and identified the characteristics of the patients most likely to exceed recommended doses…
(Reuters Health)—Acetaminophen, ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are better than opioids at easing the intensity of chronic pain in the back, knees or hips, a U.S. experiment suggests. And opioids are no better than these other drugs at reducing how much pain interferes with daily activities, such as walking, working, sleeping or enjoying…
Romosozumab’s Future Is Uncertain Romosozumab, which has the possible U.S. brand name Evenity, is awaiting approval from the FDA.1 The treatment is an investigational, injectable biologic for treating osteoporosis. It increases bone formation and bone density, reducing a patient’s risk of fractures. The manufacturer no longer expects the FDA to approve the drug this year…
First Appearances I watched the old man, his back painfully bent, shuffle toward the scale. A blocky rigidity draped over him. His feet seemed stuck to the floor. His head hung heavily over his chest. Observing him from the end of the hallway, instead of a face, I saw only a mound of shaggy, matted…
NSAIDs Increase Myocardial Infarction Risk According a recent meta-analysis of real-world non-steroidal anti-inflammatory drug (NSAID) use, NSAIDs may increase the risk of acute myocardial infarction (AMI). The analysis used individual patient data meta-analysis of studies from healthcare databases in Canada, Finland and the U.K. to determine the time course for risk of AMI, as well…
A study compared celecoxib with ibuprofen and naproxen to determine its cardiovascular safety, as well as gastrointestinal and renal outcomes, in patients with rheumatoid arthritis and osteoarthritis. The results showed that celecoxib met all prespecified noninferiority requirements and is as safe as other non-selective NSAIDs…
Nonsteroidal anti-inflammatory drugs (NSAIDs) have been used therapeutically since the 1960s.1 Evidence of adverse cardiovascular outcomes led to the withdrawal of the selective COX-2 inhibitor rofecoxib in September 2004, when the question of cardiovascular safety of NSAIDs first came into the limelight.2 Valdecoxib (Bextra) was subsequently withdrawn from the market in April 2005 due to…