Category: “Dear Doctor” Letters
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Multaq: August 2011 Update: Another Liver Failure Case Report Article In Medical Journal
New Sanofi "Dear Doctor" Letter: Label Change Regarding Heart-Related Side Effects Coming Soon (Posted by Tom Lamb at DrugInjuryWatch.com)This August 2011 update on Multaq (dronedarone) covers both liver injury and cardiovascular side effects. The medical…
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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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Sanofi-Aventis “Dear Doctor” Letter Will Warn Heart Drug Multaq Associated With Liver Failure
Liver Toxicity And Cardiac Side Effects Cause Dr. Steven Nissen To Express "concerns about the safety, efficacy and tolerability of dronedarone" (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Multaq "safety warning" issued by…
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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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Antibiotic Avelox Linked To Severe Liver Injury Side Effects, Again
Will The FDA Be The Last To Insist On Increased Warning; In Fall 2007 Bayer Updated Its Avalox Label In Europe (Posted by Tom Lamb at DrugInjuryWatch.com) On March 22, 2010 Health Canada issued a press…
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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…
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Diabetes Drug Byetta Linked To Kidney Problems And Cases Of Renal Failure
October 2009 Byetta Label Change Follows Earlier Alert From U.K. About Kidney-Related Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) In March 2009 the Drug Safety Update Newsletter alerted us about reports of kidney-related…
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Hydroxycut Weight-Loss Products Are Recalled Due To Cases Of Serious Liver Injury
Reports Made To The FDA Have Involved Hepatitis, Liver Failure, Liver Transplant, And Death (Posted by Tom Lamb at DrugInjuryWatch.com) On May 1, 2009 the FDA warned people to stop using Hydroxycut products – made…