Tag: Health Canada
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Reports Of Male Breast Cancer Associated With The Use Of Propecia And Proscar
Recent Label Change For These Drugs Made In Canada But Not In U.S., Yet (Posted by Tom Lamb at DrugInjuryWatch.com)On August 4, 2011 Health Canada issued this Information Update, "Finasteride (Propecia, Proscar): Potential rare risk…
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YAZ / Yasmin / Ocella / Beyaz / Safyral: Drug Safety Regulators Focus On Blood Clot Side Effects
EMA Orders New Warning About Risk Of Venous Thromboembolism, While FDA And Health Canada Begin Safety Review (Posted by Tom Lamb at DrugInjuryWatch.com) In recent months there has been a flurry of activity by…
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Multaq Cardiovascular Deaths Overshadow Earlier Liver Injury Concerns For Drug Regulators
FDA Now Looking At Two-Fold Increase In CV Deaths, Strokes, And Heart Failure Hospitalizations From PALLAS Study Data (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "Multaq (dronedarone) – Information on Increase in Heart-Related…
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Actos-Related Bladder Cancer: June 2011 Review Of Regulatory Actions And Safety Warnings
FDA And Health Canada Warn About Increased Risk, While France And Germany Suspend Actos Sales (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines" (8/4/11)…
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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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Health Canada And FDA Issue Adverse Reaction Updates In Second Half Of 2010 Which Involve Popular Drug Zocor (Simvastatin)
Cases Of Interstitial Lung Disease (ILD) And Rhabdomyolysis / Myopathy Associated With Cholesterol Drugs Known As Statins, Including Zocor (Posted by Tom Lamb at DrugInjuryWatch.com) _________________________________________________________________________________________ UPDATE: FDA Drug Safety Communication: New restrictions, contraindications,…
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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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Asthma Drug Xolair Is Being Investigated By FDA For Possible Cardiac Problems
Serious Side Effects Include Heart Attacks, Abnormal Heart Rhythms, Heart Failure, And Various Conditions Caused By Blood Clots (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "Xolair Is Associated With Higher Than Expected Reporting…