A recent article from Healio.com reviewed the FDA’s Pregnancy and Lactation Labeling Rule (PLLR) that became effective June 30th.

Long-term management of osteoporosis can be challenging, and given the increasing number of choices, the best sequence of drug use has not been addressed adequately.  

The rheumatology therapeutic landscape has changed almost yearly in the last 15 years, with the introduction of at least 16 biologic or novel agents for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), spondyloarthritis (SpA), juvenile arthritis,

The herpes zoster (HZ- shingles) vaccine was FDA approved for use in individuals over age 50 years.  However, the CDC Advisory Committee on Immunization Practices (ACIP) has recommended it only be used in those over age 60 years.  

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.

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).

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.

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

RheumNow is committed to reporting safety issues in our monthly Drug Safety Bulletins. Each month we will update you with reports of new, ongoing and resolved Drug Shortages that will affect the practicing rheumatologist.

The FDA is under pressure over the recent approval of the "female viagra" pill.  On August 18th, the FDA announced its approval for Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

A population-based study from Northern Denmark studied the effects of aspirin and NSAIDs on colorectal cancer rates (Citation source http://buff.ly/1KJQ6H3).

Tektonidou and coworkers have analyzed hospitalized serious infections (SIE) involving lupus patients over a 15 year period and show that SIE in SLE have increased substantially between 1996 and 2011, and in 2011 are 12 times higher than seen in patients without SLE.

Rheumatoid arthritis patients are often said to have no or a low risk of cancer.

Smoking is a well-known inciting or exacerbating factor in many inflammatory diseases, including rheumatoid arthritis, juvenile arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis.

Rituximab has been used for years with good efficacy, but with several safety concerns. Van Vollenhoven and colleagues have published the cumulative clinical trial safety experience of RTX wherein 3595 patients 1–20 (average - 4) courses over 11 years [14,816 patient-years (PY)].

Your patient with Crohn’s or ulcerative colitis has a musculoskeletal problem that needs treatment. You consider a nonsteroidal anti-inflammatory drug, but are reminded that “NSAIDs are to be avoided as these drugs will worsen inflammatory bowel disease (IBD)”.

Methotrexate was first introduced in 1955 for leukemia and in 1986 became FDA approved for the treatment of adults with severe, active, rheumatoid arthritis or children with active polyarticular-course juvenile RA.

In reviewing submitted abstracts for the 2014 ACR meeting, I was surprised by several abstracts focusing on neutropenia in patients receiving rituximab.

In July 2015, RheumNow published 73 tweets about impactful news, research and teaching points that I feel will have an impact on the rheumatology community. We had a reach (impressions) of 49,900, 63 mentions, and 1277 visits to RheumNow.com to check out what we publish.

Can We Do Better than FAERS? Brian Overstreet (of Adverseevents.com) has written on MedPageToday.com about the current state of adverse event reporting.