Commonly used arthritis drugs may cut diabetes risk among patients, study finds
NEW YORK — Patients with inflammatory conditions may have lower rates of diabetes if they take drugs commonly used to treat arthritis, according to a new study published in the Journal of the American Medical Association.
The study, conducted by researchers at Brigham and Women’s Hospital in Boston, examined nearly 14,000 patients with rheumatoid arthritis and psoriasis who took disease-modifying anthrheumatic drugs. Patients who have these diseases have significantly increased risk of developing cardiovascular disease and diabetes.
Patients were broken down into groups that took tumor-necrosis factor inhibitors — a biotech drug — methotrexate, hydroxychloroquine or non-biologic DMARDs. The researchers found that of all the groups, those taking TNF inhibitors or hydroxychloroquine had the lowest incidence of diabetes. Though the researchers found an association between lower diabetes risk and use of one of the two DMARDs, they remained uncertain as to whether the relationship was causal.
FDA accepts Endo’s resubmission for Opana ER
CHADDS FORD, Pa. — The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.
The agency had declined to approve Endo’s Opana ER (oxymorphone hydrochloride) in January for reasons that the company did not specify, though the agency did not request additional clinical studies in its statement, known as a complete response letter.
The drug is designed to prevent abuse by being resistant to crushing, which drug abusers often do with opioid painkillers so they can snort or inject them.
The agency plans to take action on the resubmission in December.
FDA panel recommends approval of Shire’s Firazyr
DUBLIN — A Food and Drug Administration expert panel has recommended approval of a drug made by Shire for a rare immune system disorder, the drug maker said.
Shire said the FDA’s Pulmonary-Allergy Drugs Advisory Committee recommended approval of Firazyr (icatibant) for treating acute hereditary angioedema attacks in adults. The committee also voted 11-1 to recommend approval of self-administration of the drug by patients.
HAE is a genetic and potentially fatal immune system disorder that causes swelling of the face and airways and result in airway blockage.
The FDA is not obligated to follow the recommendations made by advisory committees, but generally considers them when deciding whether or not to grant approval to a drug.