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Product Alert
No Approval for Rifaximin in IBS
The FDA has indicated that, before the antibiotic drug rifaximin (Xifaxan) can be approved for treating irritable bowel syndrome, its manufacturer must provide data on how the agent should be used in retreating patients with recurrent symptoms, the company said.
Mar 08, 2011
FDA Warns GERD Drugs May Deplete Magnesium
WASHINGTON -- Use of prescription or over-the-counter proton pump inhibitors (PPI) for a year or longer may lead to low levels of circulating magnesium, which may increase the risk of leg spasms, arrhythmias, and seizures, according to an FDA warning.
Mar 02, 2011
FDA Panel: Keep ECT Devices as High Risk
GAITHERSBURG, Md. -- The FDA should continue to regulate electroconvulsive therapy (ECT) machines as high-risk devices for treating depression and most other conditions for which ECT is typically used, members of the agency's Neurological Devices Advisory Committee agreed.
Jan 28, 2011
EMA Calls Halt to Reduced Dosing of Fabry Drug
Europe's equivalent of the FDA has advised that patients with Fabry disease receive the full label-recommended dosage of Genzyme's agalsidase-beta (Fabrazyme) despite the ongoing shortage of the drug, which is one of two enzyme replacement products available to treat the genetic disease.
Oct 29, 2010
ACC: Senate Probe Finds Evidence that Drug Firms Worked to Delay ENHANCE Results
CHICAGO -- E-mails made public today described outrage more than a year ago by the ENHANCE trial's principal investigator because he perceived that a drugmaker was withholding bad results about ezetimibe/simvastatin (Vytorin) for non-scientific reasons.
Mar 31, 2008
FDA Orders Black Box Warning for Gadolinium-Based Contrast Agents
ROCKVILLE, Md. -- The FDA today ordered black-box warnings for all gadolinium-based contrast agents for magnetic resonance imaging, detailing an increased risk for nephrogenic systemic fibrosis with kidney-disease patients.
May 23, 2007
FDA Warns on Mixing Antidepressants with Migraine Drugs
ROCKVILLE, Md. -- Mixing common migraine drugs such as Imitrex (sumatriptan) with antidepressants like Prozac (fluoxetine) or Cymbalta (duloxetine) can trigger a life-threatening condition called serotonin-syndrome, the FDA has warned.
Jul 20, 2006
ACP: Garlic, Ginseng, Ginkgo Biloba, and Ginger All Bad Actors with Coumadin
PHILADELPHIA - When it comes to adverse events associated with Coumadin (warfarin) therapy, beware of herbs and many supplements beginning with the letter G, according to a University of Washington investigator.
Apr 09, 2006
FDA Approves First Antidepressant Transdermal Patch
ROCKVILLE, Md. - The FDA has approved a once-a-day antidepressant patch that delivers a monoamine oxidase inhibitor. Called Emsam (selegiline), the patch can be used at its lowest dose without the dietary restrictions that accompany oral MAO inhibitors.
Mar 01, 2006