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Drug Safety Reports & FDA Updates – August 2015

Safety reports from literature include long-term safety of rituximab, rituximab-induced neutropenia, tabalumab (Anti-BAFF Mab) results from the ILLUMINATE trial, colchicine toxicity increased in CKD patients, FDA updates and drug labeling changes, and more.

Serious Infections Increased in Etanercept-Treated Juvenile Arthritis Patients

UK researchers set out to study medically significant infections (MSI) in juvenile idiopathic arthritis patients enrolled in the British Society for Paediatric and Adolescent Rheumatology Etanercept Cohort Study (BSPAR-ETN).

More Knee Replacements at Younger Ages

The National Hospital Discharge Survey shows that between 2000 and 2010, more than 5.2 million total knee replacements were performed in the United States. By 2010, the operation had become the leading inpatient surgery performed on adults aged 45 and over.

SCOT Study Shows NSAID Safety

Since the 2005 FDA hearing that resulted in the removal of Vioxx and Bextra from the US market, the safety of nonselective NSAIDs (nsNSAIDs) and selective Cox-2 inhibitors (e.g., celecoxib) has been repeatedly questioned, often without new or substantive data.

Hospitalized Infections are Higher with the Second Biologic

Using Medicare claims data on 189,326 RA patients, researchers at the University of Alabama at Birmingham examined the rates of hospitalized infections in previously biologic-treated RA patients and compared rates in cohorts starting new treatment with etanercept, adalimumab, certolizum

A Rule of Five Spots Spine Disease

A combined rule of five -- the presence of at least five fatty lesions/erosions in the sacroiliac (SI) joint, at least five fatty lesions in the spine, or at least five spinal inflammatory lesions on magnetic resonance imaging (MRI) -- is highly specific for axial spondyloarthritis in patients wi

Romosozumab Surpasses Teraparitide in the STRUCTURE Study

The experimental bone drug, romosozumab, has succeeded in meeting its primary endpoint by showing it was significantly more effective than teriparatide in a 12-month study assessing total hip bone density in postmenopausal women with osteoporosis.  

Bicycle Injuries and Fatalities Increasing in Older Americans

JAMA reports the number of traumatic injuries related to bikes in adults nearly doubled from 1998 to 2013 -- going from 8,791 to 15,427. The researchers used data from the National Electronic Injury Surveillance System, which includes data from of 100 emergency departments, and U.S.

Valeant Acquires Brodalumab from Astra-Zeneca

As reported by Reuter's Tue Sep 1, 2015 3:36am EDT

Reuters reports that Valeant Pharmaceuticals International Inc (a Canadian Pharmaceutical company) is buying rights to AstraZeneca's late-stage experimental psoriasis drug, brodalumab, after it was dropped by codeveloper Amgen Inc in May. Amgen pulled out of the project b

Advances in Uveitis Associated with Juvenile Arthritis

Uveitis is a common association of juvenile idiopathic arthritis (JIA) that has previously been characterized by poor visual prognosis with limited options for effective treatment.

MOST Study: End Stage Knee Osteoarthritis Shows Dynamic Change by MRI

Guermazi and colleagues have investigated whether end-stage knee osteoarthritis (OA), assessed as grade 4 Kellgren and Lawrence (KL) radiographic changes, are really "end stage".   

Life Expectancy Rises, but People Living Longer with More Illness

Lancet has reported that people are living 6.2 years longer, worldside since 1990.  Yet, there has been a rise in illness and disability,and a complex mix of fatal and non-fatal ailments leading to a large amount of health loss.

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