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Patients with OA Respond to Low-Dose SoluMatrix Meloxicam; Off-Label Use of Ketoconazole Results in Death

Michele B. Kaufman, PharmD, BCGP  |  June 8, 2016

In a clinical trial, patients with osteoarthritis taking low-dose SoluMatrix meloxicam used less rescue medication to manage pain. Also, the FDA has issued a new warning against using oral ketoconazole off label to treat onychomycosis and fungal skin infections…

FDA Panel Backs Teva’s Abuse-Resistant Opioid Painkiller

Natalie Grover & Toni Clarke  |  June 8, 2016

(Reuters)—A U.S. Food and Drug Administration (FDA) advisory panel recommended approving Teva Pharmaceuticals Industries Ltd’s long-acting opioid painkiller, Vantrela ER, saying data showed it reduces pain and has some abuse-resistant properties. The drug is designed for use every 12 hours for the management of pain severe enough to require around-the-clock treatment in patients who have…

Extra Bone Resorption in Pregnancy, Lactation May Pass Maternal Lead Burden to Baby

Reuters Staff  |  June 7, 2016

NEW YORK (Reuters Health)—Bone resorption increases during pregnancy and continues to be high postpartum, according to new findings using lead testing to measure bone turnover. Researchers also found unexpected evidence that maternal lead burden is transferred to the fetus. “These data confirm calcium balance studies that indicate increased bone resorption throughout pregnancy and lactation,” Dr….

Researchers Calculate Comorbidity Burden for Patients with SLE

Arthritis Care & Research  |  June 7, 2016

A recent study from the U.K. calculated the incidence of comorbidity associated with systemic lupus erythematosus (SLE), specifically looking for cardiovascular disease, stroke, end-stage renal failure, cancer, osteoporosis and infection. Even after adjusting for age, sex and other variables, investigators found that people with SLE have an increased global burden of comorbidity compared with the general population. Additionally, the study found that men with SLE had higher rates of cardiovascular disease, stroke and cancer, while women with SLE had higher rates of infection and osteoporosis. Overall, younger people with SLE had the greatest relative risk compared with controls…

Immunotherapy Largely Untested in Patients with Autoimmune Disease

Andrew M. Seaman  |  June 6, 2016

(Reuters Health)—The safety and effectiveness of cancer immunotherapy is largely unknown in patients with autoimmune diseases, researchers say—and that might account for up to a quarter of individuals with lung cancer. Patients with autoimmune diseases, such as rheumatoid arthritis, ulcerative colitis or psoriasis, have been mostly excluded from clinical trials testing immunotherapies over fears that…

Patients with RA Who Respond to Treatment Experience Increased Cholesterol

Lara C. Pullen, PhD  |  June 6, 2016

New research confirms that patients with rheumatoid arthritis who respond to treatment experience an increase in cholesterol levels, including total cholesterol, LDL-C and HDL-C levels. However, the use of triple therapy may be important for understanding this association and mitigating its risk…

Many Medical Devices Hit the Market before Safety Studies Are Published

Madeline Kennedy  |  June 5, 2016

(Reuters Health)—Medical devices approved by the U.S. Food and Drug Administration (FDA) are often cleared before studies on their safety or effectiveness have been released to the public, a report suggests. Without published data, doctors and patients may not be able to make informed decisions about whether to use the products, the authors warn. The…

Biomarkers Differentiate Crohn’s Disease from Ulcerative Colitis

Marilynn Larkin  |  June 4, 2016

NEW YORK (Reuters Health)—Newly identified biomarkers could aid in the diagnosis of inflammatory bowel disease (IBD) and help guide therapy, Canada-based researchers report. Accurately differentiating between Crohn’s disease (CD) and ulcerative colitis (UC) is important for ensuring early and appropriate treatment. However, the conditions can’t be reliably distinguished based on clinical symptoms, site of disease,…

Bacterial Curli Amyloid: Researchers Examine the Role of Bacterial Infection in Lupus Pathology

Richard Quinn  |  June 3, 2016

New research has found that the amyloid protein curli triggers immune activation and autoantibody production in lupus-prone and wild-type mice. Stefania Gallucci, MD, says these results provide insight into the mechanisms of bacterial infection that may result in lupus…

Sun Pharma Gets U.S. Subpoena over Generic Drugs Pricing

Reuters Staff  |  June 1, 2016

MUMBAI (Reuters)—The U.S. Department of Justice (DOJ) has subpoenaed India’s largest drugmaker Sun Pharmaceutical Industries Ltd. seeking information about the pricing and marketing of the generic drugs it sells in the U.S., the company said on Saturday. The DOJ’s antitrust division has also asked Sun Pharma’s U.S. unit for documents related to employee and corporate records…

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