Blog Archives

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

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). 

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

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 multiple sclerosis (MS).

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

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 Nieuwkamp,

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

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 treated with Tecfidera.

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

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 treat those conditions when one or more standard therapies (corticosteroids,

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

January 16, 2012 – The American Food and Drug Administration ( FDA) released on January 13, 2012 the following drug safety communication:

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ISSUE: FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death,

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

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 (PTLD) and Progressive Multifocal Leukoencephalopathy (PML), both of which can be fatal.

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

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 is a drug too risky to stay on the market?

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Rituximab [Rituxan] – Progressive Multifocal Leukoencephalopathy [PML]

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 received treatment with a TNF antagonist.

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