Tag: Novartis
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August 2015 Gilenya Label Change About PML Brain Infection Follows FDA Drug Safety Alert About This Serious Side Effect
These Two PML Cases Did Not Involve The Patients Previously Using The MS Drug Tysabri, As Did The One Which FDA Reported In August 2013 (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________…
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A New Case Of Progressive Multifocal Leukoencephalopathy (PML) In A Patient Using Gilenya Is Reported By Novartis In Canada
Company Is Investigating This Gilenya – PML Case To See Whether Brain Disease Might Be A Side Effect Of Its MS Drug (Posted by Tom Lamb at DrugInjuryWatch.com) Gilenya (fingolimod) capsules were approved by the FDA in…
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Various Drug Safety Issues Continue To Be Associated With Novartis Multiple Sclerosis (MS) Medication Gilenya
ISMP QuarterWatch Report From 2014 States Adverse Events Reports Show That Gilenya Cardiac Risks "were neither rare nor hypothetical" (Posted by Tom Lamb at DrugInjuryWatch.com)The safety profile for the Novartis drug Gilenya (fingolimod) has been controversial for…
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Tekturna And Other Aliskiren Related Blood Pressure Medications Can Cause Renal Failure, Kidney Complications, And Strokes
Concomitant Use Of Tekturna With ACE Inhibitors And ARBs Contraindicated In Patients With Diabetes; Plus An FDA Caution Regarding Renal Impairment (Posted by Tom Lamb at DrugInjuryWatch.com) Tekturna (aliskiren) was approved by the FDA…
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Multiple Sclerosis (MS) Medication Gilenya: Timeline Of Actions Taken In US, Canada, And Europe
Increasing Safety Concerns About Novartis Drug Gilenya Are Primarily Cardiovascular Side Effects And Unexplained Death (Posted by Tom Lamb at DrugInjuryWatch.com) In August 2012 Health Canada issued the latest drug safety alert concerning Gilenya…
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Reclast “Dear Doctor” Letter For Kidney Problems Should Be Sent By Novartis In U.S.
Public Citizen March 2011 Letter To FDA Points To Aclasta Safety Alert Material Sent In Canada During October 2010 (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: On September 1, 2011 the FDA announced…
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Osteoporosis Medication Aclasta Associated With Renal Impairment And Kidney Failure
Novartis Sends "Dear Doctor" Letter To Canadian Physicians With Health Canada Endorsed Safety Information (Posted by Tom Lamb at DrugInjuryWatch.com) In 2007 Aclasta (zoledronic acid 5mg) was approved by the FDA under the brand name Aclasta®…
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FDA And Novartis Announce A Label Change For Iron Chelating Drug Exjade In Mid-February 2010
Includes A New "Black Box" Warning About Renal Impairment, Liver Failure, And Gastrointestinal Hemorrhage (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-February 2010 the FDA and Novartis announced a change to the Prescribing Information…
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December 2009: Voltaren Gel And Other Products Containing Diclofenc Sodium Linked To Liver Problems
"Dear Doctor" Letter From Endo And Novartis Offers Information About Prevention And Diagnosis Of Drug-Induced Liver Injury (DILI) (Posted by Tom Lamb at DrugInjuryWatch.com) On December 4, 2009 the FDA issued this MedWatch alert, "Voltaren…