Home» Medical News

FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)

Views: 506
Date: 29 Jan 2012
Definition of medical terminology for Food.
A microorganism smaller than a bacteria, which cannot grow or reproduce apart from a living cell.
Definition of medical terminology for Risk.
Definition of medical terminology for Progressive Multifocal Leukoencephalopathy.
The U.S. Food and Drug Administration (FDA) is informing the public that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML).

Definition of medical terminology for Brain.
Definition of medical terminology for Infection.
Definition of medical terminology for Multiple Sclerosis.
Definition of medical terminology for Sclerosis.
Definition of medical terminology for Disease.
Definition of medical terminology for Body Build.
Definition of medical terminology for Forms.
Definition of medical terminology for Multiple Sclerosis.
Definition of medical terminology for Sclerosis.
Definition of medical terminology for Disease.
Definition of medical terminology for Risks.
Definition of medical terminology for Patients.
An immunoglobulin, a specialized immune protein, produced because of the introduction of an antigen into the body, and which possesses the remarkable ability to combine with the very antigen that triggered its production.
Definition of medical terminology for Risk.
Definition of medical terminology for Patients.
Definition of medical terminology for Risk.
Definition of medical terminology for Risk.
Definition of medical terminology for Risk.
In anatomy, one of the two layers of compact bone
Definition of medical terminology for Risk.
In anatomy, one of the two layers of compact bone
An immunoglobulin, a specialized immune protein, produced because of the introduction of an antigen into the body, and which possesses the remarkable ability to combine with the very antigen that triggered its production.
An immunoglobulin, a specialized immune protein, produced because of the introduction of an antigen into the body, and which possesses the remarkable ability to combine with the very antigen that triggered its production.
Definition of medical terminology for Healthcare.
Definition of medical terminology for Professional Activity Studies.
An immunoglobulin, a specialized immune protein, produced because of the introduction of an antigen into the body, and which possesses the remarkable ability to combine with the very antigen that triggered its production.
Enzyme-linked immunosorbent assay
Definition of medical terminology for Person.
Definition of medical terminology for Past Trend.
Definition of medical terminology for Brain.
Definition of medical terminology for Nerve Fibers.
A microorganism smaller than a bacteria, which cannot grow or reproduce apart from a living cell.
Definition of medical terminology for Systems Agencies, Health.
Definition of medical terminology for Human Immunodeficiency Virus.
A microorganism smaller than a bacteria, which cannot grow or reproduce apart from a living cell.
Definition of medical terminology for Leukemia.

PML is a rare but serious brain infection associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) or Crohn`s disease.

Facts about Tysabri (natalizumab)

In a class of medications called immunomodulators. It works by stopping certain cells of the immune system from causing damage to the body .
Has been approved by the FDA for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn`s disease since January 2008.

The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML. Patients with all three known risk factors have an estimated risk of PML of 11/1,000 users. The risk factors are:

The presence of anti-JCV antibodies.
Longer duration of Tysabri treatment, especially beyond 2 years.
Prior treatment with an immunosuppressant medication (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, or mycophenolate mofetil).

The drug label for Tysabri has been revised to reflect this updated information including a table estimating the rate of PML stratified by the three known risk factors (see Table 1 below).

A patient`s anti-JCV antibody status may be determined using an anti-JCV antibody detection test that has been analytically and clinically validated, and has been ordered by a healthcare professional . The Stratify JCV Antibody ELISA test was cleared by FDA on January 20, 2012. Testing positive for anti-JCV antibodies means that a person has been exposed to JCV in the past .

PML is a rare disorder in which the coating (myelin) of some brain nerve fibers gets damaged. Although JCV is a common virus that is generally harmless and does not cause symptoms in people whose immune systems function normally, it can cause PML in people with weakened immune systems . Causes of a weakened immune system may include human immunodeficiency virus (HIV) infection, leukemia or lymphoma, or taking a medication such as Tysabri.


Source : DrugsFreeList.com
Tags: myelin, Tysabri, natalizumab, brain infection, progressive multifocal leukoencephalopathy

Latest Medical News

» U.S. Food And Drug Administration Approves Pfizer’s INLYTA (axitinib) For Patients With Previously Treated Advanced Renal Cell Carcinoma (RCC)
-Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved INLYTA® (axitinib), a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma (RCC)


» Pfizer Announces FDA Acceptance Of New Drug Application For Bosutinib For Patients With Previously Treated Ph Chronic Myeloid Leukemia
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for standard review of bosutinib as a treatment option for adult patients with previously treated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).


» FDA approves Inlyta to treat patients with a type of advanced kidney cancer
The U.S. Food and Drug Administration approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.


» FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
The U.S. Food and Drug Administration (FDA) is informing the public that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML).


» FDA. New and Generic Drug Approvals - January 27, 2012
New drugs approved. List of drugs approved by FDA to date January 27, 2012


» FDA. New and Generic Drug Approvals - January 26, 2012
New drugs approved. List of drugs approved by FDA to date January 26, 2012


» FDA. New and Generic Drug Approvals - January 25, 2012
New drugs approved.List of drugs approved by FDA to date January 25, 2012


» FDA. New and Generic Drug Approvals - January 24, 2012
New drugs approved. List of drugs approved by FDA to date January 24, 2012


» FDA. New and Generic Drug Approvals - January 23, 2012
New drugs approved.List of drugs approved by FDA to date January 23, 2012


» FDA. New and Generic Drug Approvals - January 20, 2012
New drugs approved. List of drugs approved by FDA to date January 20, 2012


» FDA. New and Generic Drug Approvals - January 19, 2012
New drugs approved. List of drugs approved by FDA to date January 19, 2012


» FDA. New and Generic Drug Approvals - January 18, 2012
New drugs approved. List of drugs approved by FDA to date January 18, 2012


» FDA expands use of endovascular graft to treat aortic tears
The U.S. Food and Drug Administration expanded the approved usage for an endovascular graft manufactured by W.L. Gore and Associates Inc. to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection).


» FDA approves Voraxaze to treat patients with toxic methotrexate levels
The U.S. Food and Drug Administration approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.


» FDA Drug Safety Communication: New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin)
The U.S. Food and Drug Administration (FDA) is notifying the public that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin).


General Search


Last medical tags:


Torisel, temsirolimus, Inlyta, chronic myeloid leukemia, bosutinib, Inlyta, renal cell carcinoma, kidney cancer, myelin, Tysabri, natalizumab, brain infection, progressive multifocal leukoencephalopathy, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, thoracic aortic transection, endovascular graft, methotrexate, Voraxaze, cancer chemotherapy drug, glucarpidase, Adcetris, bleomycin, multifocal leukoencephalopathy, CardioGen-82, radiation, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, raltegravir, Isentress, antiretroviral medicines, Theravance, Relovair, asthma, fluticasone, bronchitis, neuromuscular disease, SMA, muscle atrophy, Resolor, prokinetic, prucalopride, ADHD, psychiatric behavioural disorder, Venvanse, lisdexamfetamine dimesylate, type 2 diabetes mellitus, Actoplus Met XR, pioglitazone, Mylan, Eprosartan Mesylate Tablets, Teveten, antimicrobials, cephapirin, cephalosporin, teriflunomide, Rebif, alanine aminotransferase levels, flu-like symptoms, multiple sclerosis, electrical pulses, implantable pulse generator, Precision Plus Spinal Cord Stimulator, genetic blood clotting disorder, hemophilia A, Advate, bleeding episodes, heart failure, heart transplantation, Pediatric Medical Device Safety, pulsatile cardiac assist device, selective serotonin reuptake inhibitor, SSRI, pulmonary hypertension,
» All tags  
Sitemap