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Category Archives: Neurology
Tysabri (natalizumab) Drug Safety Communication
Tysabri (natalizumab): Drug Safety Communication – New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML) AUDIENCE: Neurology, Gastroenterology ISSUE: FDA notified healthcare profesisonals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal … Continue reading
Adcetris (brentuximab vedotin) Drug Safety Communication
Adcetris (brentuximab vedotin): Drug Safety Communication – Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity AUDIENCE: Oncology, Hematology, Neurology ISSUE: FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in … Continue reading
Posted in FDA 2011, FDA Label Change, FDA Notice, FDA Warning, Hematology, Neurology, Oncology
Tagged Adcetris, Adcetris (brentuximab vedotin) Drug Safety Communication, brentuximab vedotin, drug risks, Drug Safety Communication, FDA notice, FDA warning, Progressive Multifocal Leukoencephalopathy, Pulmonary Toxicity, safety label changes
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Gilenya (fingolimod) Drug Safety Communication
Gilenya (fingolimod): Drug Safety Communication – Safety Review of a Reported Death After the First Dose AUDIENCE: Neurology, Patients ISSUE: The FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking … Continue reading
Posted in FDA 2011, FDA Notice, multiple sclerosis (MS), Neurology
Tagged Drug Safety Communication, FDA notice, Gilenya (fingolimod), Gilenya (fingolimod) Drug Safety Communication, multiple sclerosis (MS), Neurology
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