Mirtazapine has been prescribed off-label to fibromyalgia patients who have not responded to other treatments. However, a recent systemic review found no difference between mirtazapine and placebo for these patients, and any potential benefits from mirtazapine may not outweigh its potential harm, including drowsiness, weight gain and liver damage…
NEW YORK (Reuters Health)—Adverse drug events (ADEs) are more common when drugs are used off label, especially when the off-label use lacks strong scientific evidence, researchers from Canada report. “Our study demonstrated that physicians need to be cautious in prescribing off-label when there is a lack of strong scientific evidence for the use of the…
NEW YORK (Reuters)—Pacira Pharmaceuticals Inc. on Tuesday filed a lawsuit seeking a court order allowing it to promote its post-surgery pain drug, Exparel (bupivacaine liposome injectable suspension), for a wide range of surgeries, which the U.S. Food and Drug Administration opposes. The lawsuit, filed in federal court in Manhattan, cites another New York judge’s recent…
Last month’s “Rheumatology Practice Pearls” focused on the denial or return of preauthorization requests because of missing data. This month’s pearls focuses on obtaining authorization for off-label drugs and updating a previous preauthorization.