Safety Reports in the News
Can We Do Better than FAERS? Brian Overstreet (of Adverseevents.com) has written on MedPageToday.com about the current state of adverse event reporting.
News
ACTEMRA Gets "Breakthrough" Status from the FDA for Scleroderma
The FASSCINATE study presented at EULAR 2015 was instrumental in tocilizumab (TCZ) getting a nod from the FDA to develop TCZ for scleroderma.
Vitamin D Fails in Postmenopausal Osteoporosis Prevention
JAMA reports that investigators from the University of Wisconsin in Madison studied the impact of vitamin D supplements on 230 women who were at least five years past menopause but no older than 75, and without osteoporo
Legionella Outbreak in NYC
An outbreak of Legionnaires' disease has killed four people and sickened 65 in the Bronx section of New York City since July 10, according to New York City health officials. This Legionnaires' outbreak is now more than five times the number of cases recorded in the last outbre
CDC Report: 22% of USA Population is Disabled
CDC has released the findings of its 2013 Behavioral Risk Factor Surveillance System (BRFSS), with 5 questions addressing different forms of disability - vision, cognition, mobility, self-care, and independent living. Overall, 22.2% of U.S. adults (53,316,677 persons) reported any disability.
NSAIDs are Risky in Patients with Chronic Kidney Disease
Little is known about what happens when NSAIDs are used in patients with chronic kidned disease (CKD), especially those with hypertension.
Lipid Levels and CV Events in RA
Rheumatoid arthritis not only affects the joints but can also increase risk for cardiovascular disease. The mechanism of the increased risk of cardiovascular disease in rheumatoid arthritis remains uncertain.
B cell Inhibition with Epratuzumab Fails in Two Phase III Lupus Trials
Targeting B cells in systemic lupus erythematosus, the prototypic autoimmune disorder, has long been an attractive target for researchers. Despite negative trials with rituximab and the limited success of belimumab, efforts to inhibit B cell activity have continued.
Men and Blacks Undertreated for Osteoporosis
Using claims data from 36,965 patients in an Indiana database, researchers found women (OR 1.86) and non-black patients (OR 1.52) were more likely to be treated (p<0.001) for osteoporosis.
Gut Dysbiosis in RA Reflects Activity, Serology and Response
Using a metagenome-wide association study (MGWAS) of fecal, dental and salivary samples from rheumatoid arthritis and healthy controls, Zhang et al showed that gut and oral microbiomes are highly concordant and that in RA there is a distinct dysbiosis with less Haemophilus spp.
Is Morning Stiffness Important?
Morning stiffness? An oft-asked question, but does it have reliable discriminatory value?
Not All Placebos are Equal: The Needle is Mightier than the Pill
Placebos are necessary to determine the “true effect” of any medical intervention. As such, they have become the cornerstone of evidence-based medicine, randomized controlled clinical trials and novel drug development.
