[update] The US FDA reviewed the results of the ORIENT and ROADMAP trials and determined that Benicar’s benefits, when used for the treatment of patients with high blood pressure, outweigh the potential risks. Nevertheless, Benicar use is not recommended as a treatment to delay or prevent protein in the urine (microalbuminuria) in diabetic patients. The [...]
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Oncology and Cardiology healthcare personnel are informed by the FDA that the injection form of Anzemet (dolasetron mesylate) should no longer be used to prevent nausea and vomiting related to cancer chemotherapy because the risk of developing abnormal heart rhythm exists. Background of Anzemet Cardiovascular safety concerns have already been noted by the FDA suggesting [...]
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After completion of the evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod) the US FDA could not definitively conclude that Gilenya was related to any of the deaths. Nevertheless the agency remains concerned about the cardiovascular effects of Gilenya after the first dose. Background [...]
Read more06/24/2011 The FDA has notified healthcare professionals that there are new, modified recommendations for using smaller doses of Erythropoiesis-Stimulating Agents (ESAs) in patients who have chronic kidney disease, that have been approved to improve the safe usage of the drug. ESAs are usually used to treat certain types of anemia by stimulating the bone marrow [...]
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