All News
PLLR - The Pregnancy & Lactation Labeling Rule Explained
A recent article from Healio.com reviewed the FDA’s Pregnancy and Lactation Labeling Rule (PLLR) that became effective June 30th.
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DATA-Switch Study Finds the Right Sequence to Building Better Bone Mass
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.
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Monitoring of Novel Therapies in Rheumatology
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,
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Shingles Vaccine Not Cost-Effective in Those Under 60
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.
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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.
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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).
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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.
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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
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DSB: Drug Shortages August 2015
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.
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Female "Viagra Pill" Controversy - Grandstanding or Equal Rights?
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.
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Colon Cancer Risk Cut by Aspirin and NSAIDs
A population-based study from Northern Denmark studied the effects of aspirin and NSAIDs on colorectal cancer rates (Citation source http://buff.ly/1KJQ6H3).
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Serious Infections are Increasing in Lupus
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.
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Cancer Risk Is Both Increased and Decreased in RA
Rheumatoid arthritis patients are often said to have no or a low risk of cancer.
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Patients Unaware that Smoking Worsens IBD
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.
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Long-Term Safety of Rituximab
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)].
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NSAIDs and the Risk of Inflammatory Bowel Disease
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)”.
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DSB: Managing Methotrexate Toxicity
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.
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Rituximab Induced Neutropenia
In reviewing submitted abstracts for the 2014 ACR meeting, I was surprised by several abstracts focusing on neutropenia in patients receiving rituximab.
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Heel Pain, Uveitis, TB, Vitamin D, Hidradenitis: July 2015 top social media news
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.
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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.
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