According to a new safety communication recently released by FDA, the agency is continuing to receive reports of a rare but aggressive white blood cell cancer often referred to as hepatosplenic T-cell lymphoma in patients receiving tumor necrosis factor blockers, azathioprine, and mercaptopurine.
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Rivaroxaban: a novel oral factor Xa inhibitor to prevent stroke in nonvalvular atrial fibrillation
July 1st 2011Rivaroxaban is an oral, direct factor Xa inhibitor under review by FDA for stroke prevention in patients with atrial fibrillation. Atrial fibrillation conveys a 5-fold increased risk for stroke.
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Adoption of evidence-based therapies associated with increased survival of STEMI patients
July 1st 2011In a recently published observational registry study, researchers have demonstrated that the utilizatio of evidence-based therapies in patients experiencing ST-elevation myocardial infarction is on the rise.
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Breaking news: FDA issues CRL for Remoxy, cites inconsistencies in its drug release performance
June 28th 2011Pfizer?s second attempt at an abuse-resistant formulation of oxycodone (Remoxy) recently received a complete response letter (CRL) from FDA. Just a week earlier, FDA approved another of the drug maker?s abuse-resistant products ? immediate-release Oxecta (oxycodone HCl) ? for the management of acute and chronic moderate-to-severe pain.
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Breaking news: FDA calls for changes in ESA dosing for patients with chronic kidney disease
June 28th 2011FDA has announced more conservative dosing recommendations for erythropoiesis-stimulating agents (ESAs) when they are used to treat anemia in patients with chronic kidney disease (CKD) because of increased risk of cardiovascular events such as stroke, thrombosis, and death.
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Crizotinib shows early promise as treatment for ALK+ NSCLC
June 24th 2011Crizotinib demonstrated an association with a sharp increase in survival rates for patients with advanced non-small cell lung cancer with an anaplastic lymphoma kinase positive genetic alteration, according to the results of a study presented at the annual meeting of the American Society of Clinical Oncology.
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FDA warns of adverse cardiovascular events associated with varenicline, notes label change
June 24th 2011Safety information regarding varenicline will be added to the Warnings and Precautions section of the label and to the patient Medication Guide because smoking cessation aid varenicline may be associated with an increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.
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