August 23, 2019 – Progressive multifocal leukoencephalopathy (PML) is a rare and often fatal viral disease characterized by progressive damage or inflammation of the white matter of the brain at multiple locations (i.e., multifocal). It is caused by the JC virus, after …

Therapies that promote progressive multifocal leukoencephalopathy (PML) Read more »

Tagged with: , , , , , , , , , , , , , , , , , , , , , , , , , , ,

January 20, 2016 – The American Food and Drug Administration (FDA) just approved Ofatumumab (Arzerra)  Injection for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab, also …

Ofatumumab (Arzerra) approved for recurrent or progressive chronic lymphocytic leukemia (CLL) Read more »

Tagged with: , , , , , , , , ,

August 06, 1015 – The American Food and Drug Administration (FDA) has just issued a warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Fingolimod (Gilenya) for …

Fingolimod (Gilenya): Warning about rare cases of progressive multifocal leukoencephalopathy (PML) Read more »

Tagged with: , , , , , , , ,

April 11, 2015 – Dutch clinicians report what they believe is the first case of progressive multifocal leukoencephalopathy (PML) after treatment with compounded dimethyl fumarate (DMF) in a patient without severe lymphocytopenia. This situation was “previously thought to be unlikely,” Dennis …

Theragenomic medicine: First case of fumarate-linked progressive multifocal leukoencephalopathy (PML) in nonlymphopenic patient Read more »

Tagged with: , , , ,

November 7, 1014 –  This report originates from the meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) on 3-6 November 2014 at EMA. At this meeting, the PRAC took note and advised on informing about first case of PML in a patient …

First Case of Progressive Multifocal Leukoencephalopathy (PML) in a Patient Treated with Dimethyl Fumarate [Tecfidera] Read more »

Tagged with: , , , ,

May 22, 2014 – The U.S. Food and Drug Administration  approved  on May 20, 2014, Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease. Entyvio is approved to …

Vedolizumab [Entyvio]: FDA approves Entyvio to treat ulcerative colitis and Crohn’s disease Read more »

Tagged with: , , , , ,

January 16, 2012 – The American Food and Drug Administration ( FDA) released on January 13, 2012 the following drug safety communication: _________________ ISSUE: FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious …

Drug Safety Communication on Brentuximab Vedotin [Adcetris] – Progressive Multifocal Leukoencephalopathy (PML) and Pulmonary Toxicity Read more »

Tagged with: , , , ,

July 7, 2011 – Bristol-Myers Squibb (BMS) today informed healthcare professionals about a REMS (Risk Evaluation and Mitigation Strategy) that is required for Belatacept [Nulojix] to ensure that the benefits of Belatacept [Nulojix] outweigh the risks of Post-Transplant Lymphoproliferative Disorder …

Belatacept [Nulojix]: Increased Risk of Post-Transplant Lymphoproliferative Disorder (PTLD) and Progressive Multifocal Leukoencephalopathy (PML) Read more »

Tagged with: , , ,

July 04, 2010 – The arthritis pill Rofecoxib [Vioxx] was withdrawn from the market but menopause hormones were not, even though both were tied to heart risks. A multiple sclerosis medicine was pulled and later allowed back on. So, when …

When is a drug too risky to stay on the market? Read more »

Tagged with: , , , , ,

October 23, 2009 – Today, Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with Rituximab [Rituxan] who has not previously …

Rituximab [Rituxan] – Progressive Multifocal Leukoencephalopathy [PML] Read more »

Tagged with: ,