(Reuters Health)—Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in JAMA, online Aug. 15. The Accelerated Approval pathway makes potentially promising investigational medicines available for use before the…
Articles by Natasha Yetman
FDA Approves Duzallo for Hyperuricemia in Patients with Uncontrolled Gout
(Reuters)—Ironwood Pharmaceuticals Inc. said on Monday the U.S. Food and Drug Administration (FDA) approved its oral drug to treat a condition associated with gout. The company’s once-daily drug, Duzallo (lesinurad and allopurinol), was approved to treat hyperuricemia in patients with gout, Ironwood said. Duzallo combines the standard-of-care treatment, allopurinol, with Ironwood’s lesinurad to treat inefficient…
Switching from Bisphosphonates to Teriparatide May Improve BMD in Women with RA
NEW YORK (Reuters Health)—Switching women with rheumatoid arthritis (RA) from oral bisphosphonates to teriparatide increases bone mineral density (BMD) and trabecular bone score, according to a new report. Researchers in Japan conducted an 18-month observational study of more than 175 women with RA (mean age: 66) who remained on oral bisphosphonates, switched to denosumab (DMAb),…
Lipids, Statin Treatment Linked to Revision Rate After Rotator Cuff Repair
NEW YORK (Reuters Health)—Elevated lipid levels are associated with an increased revision-surgery rate after arthroscopic rotator cuff repair, while statin use appears to mitigate that increase, according to a database review. “[Although] it supported our hypothesis, we found it interesting to finally demonstrate a link between hyperlipidemia and rotator cuff-repair failure resulting in revision surgery…
Some Jobs Tied to Higher Risk of RA
(Reuters Health)—Workers exposed to airborne toxins may have an elevated risk of developing rheumatoid arthritis (RA), an immune system disorder that causes debilitating swelling and pain in the joints, a Swedish study suggests. Among men, bricklayers, concrete workers and electricians had at least twice the risk of RA they would have in certain other occupations,…
Sleep Therapy May Help Ease Knee Pain
(Reuters Health)—Patients with knee osteoarthritis (OA) and insomnia may be less troubled by joint pain after they get treatment to help them sleep better, a recent study suggests. Knee OA, a leading cause of pain and disability in older adults, occurs when flexible tissue at the ends of bones wears down. Although it can’t be…
Little Evidence Shows Cannabis Helps Chronic Pain or PTSD
(Reuters Health)—Even though pain and posttraumatic stress disorder (PTSD) are among the most common reasons people use medical marijuana in the U.S., there isn’t much proof cannabis works for either one of these conditions, two research reviews suggest. That’s because there hasn’t been enough high-quality research to produce conclusive evidence of the benefits or harms…
S.C. Sues Purdue, Maker of OxyContin, Over Deceptive Marketing
(Reuters)—On Tuesday, South Carolina sued Purdue Pharma LP, becoming the latest state or local government to accuse the OxyContin maker of deceptive marketing practices that have contributed to a national opioid addiction epidemic. The lawsuit by South Carolina Attorney General Alan Wilson, filed in Richland County Court of Common Pleas in Columbia, accuses the company…
New Hampshire Sues Purdue Pharma over Opioid Marketing
(Reuters)—New Hampshire sued OxyContin maker Purdue Pharma LP on Tuesday, joining several state and local governments in accusing the drugmaker of engaging in deceptive marketing practices that have helped fuel a national opioid addiction epidemic. The lawsuit filed in Merrimack County Superior Court claimed that Purdue Pharma significantly downplayed the risk of addiction posed by…
DEA Proposes Cutting Production of Come Opioids
(Reuters)—The U.S. Drug Enforcement Administration (DEA) on Friday proposed a 20% reduction in the manufacture of certain commonly prescribed opioid painkillers, as well as other controlled substances for next year. The proposal comes as U.S. regulators and lawmakers take steps to limit the supply of opioids—a class of drugs that include prescription painkillers and heroin—to…
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