After meeting with the FDA, the makers of intravenous meloxicam plan to resubmit the treatment’s new drug application…
More Evidence TNF Inhibitors Raise Risk of Peripheral Neuropathy
NEW YORK (Reuters Health)—A large epidemiological study provides more evidence of a link between tumor necrosis factor inhibitors (TNFi) and peripheral neuropathy (PN). “These events are rare and the benefit of these drugs still outweigh this risk so this should not change practice,” cautions first author Dr. Mahyar Etminan from the University of British Columbia…
Taking Vitamin D Supplements May Not Improve Bone Health
(Reuters Health)—Vitamin D supplementation may not improve bone density or prevent fractures and falls in adults, a large new analysis suggests. After combining data from 81 randomized controlled trials, researchers found no bone benefits from supplementing the vitamin, according to the report in The Lancet Diabetes & Endocrinology, online October 4. “Our results show that…
Antidepressant of No Clear Value in Chronic Low-Back Pain
NEW YORK (Reuters Health)—Low-dose amitriptyline does not have clear benefits for patients with chronic low-back pain that has no specific cause, according to results from a randomized clinical trial. Despite the lack of evidence that antidepressants are more effective than placebo for low-back pain, seven of 14 national and international guidelines recommend their use in…
Trio Wins Chemistry Nobel for Work on Antibody Drugs & Detergents
STOCKHOLM/LONDON (Reuters)—Two Americans and a Briton won the 2018 Nobel Prize for Chemistry on Wednesday for harnessing the power of evolution to generate novel proteins used in everything from environmentally friendly detergents and biofuels to cancer drugs. The fruits of this work include the world’s top-selling prescription medicine – the antibody injection Humira sold by…
FDA Expands Safety Measures for Immediate Release Opioids
The FDA has expanded the new Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) to include immediate release opioids. The program, which also includes extended release and long acting opioids, will provide education to prescribers and healthcare professionals…
TNFi Exposure in Utero
Vinet et al. evaluated the risk of serious infections in children of women with RA exposed to TNFi’s in the gestational period compared with unexposed offspring of women with RA, as well as with children from the general population. Although the research did not demonstrate a marked excess risk for serious infections, the authors could not exclude a differential risk according to specific TNFi, with infliximab potentially resulting in a threefold increase in the risk of serious infections compared with other TNFi’s. More studies are needed…
FDA Issues Safety Warning
The FDA is warning that patients with type 2 diabetes taking SGLT2 inhibitors may be at risk of developing a rare, serious infection, Fournier’s gangrene…
California Insurance Commissioner Sues AbbVie over Humira
(Reuters)—On Tuesday, Insurance Commissioner Dave Jones filed a complaint on behalf of the State of California against AbbVie Inc., alleging the drugmaker gave illegal kickbacks to healthcare providers to prescribe its blockbuster drug, Humira. The regulator alleged that AbbVie engaged in a far-reaching scheme including cash, meals, drinks, gifts, trips and patient referrals, as well…
Rheumatoid Arthritis Patients on Biologics Remain At Risk of Infection
AMSTERDAM—With new therapies coming into the marketplace, researchers are working to tease out the risk of infection for rheumatoid arthritis (RA) patients. Existing data suggest the risk of infections—even fatal ones—is real. But over time, improvements have taken hold, particularly for tuberculosis, according to an infectious disease expert at EULAR: the Annual European Congress of…
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