Tag: drug safety
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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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Sanofi Heart Medication Multaq Has Constantly Been On FDA’s Radar During 2010 And 2011
Liver Failure, Renal Impairment, And Cardiovascular Problems Cited As Potential Signals Of Risk Involving Multaq (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Health Canada announced on July 21, 2011 that it is reviewing…
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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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Ortho Evra “Black-Box” Warning About Risks Of Blood Clots Added To Package Insert In March 2011
Warnings Increased About Risk Of Side Effects Like Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT) (Posted by Tom Lamb at DrugInjuryWatch.com)In March 2011 Ortho-McNeil-Janssen Pharmaceuticals, Inc. revised the Prescribing Information (more commonly called…
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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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Zithromax Label Adds Warning About Drug-Induced Liver Injury In February 2011
Adverse Reactions And Warnings Sections Now Include Hepatotoxicity, From Hepatic Dysfunction To Liver Failure (Posted by Tom Lamb at DrugInjuryWatch.com) The association between the antibiotic Zithromax (azithromycin) and drug-induced liver failure first received some real…
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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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Zocor Label Change: Interstitial Lung Disease (ILD) Added As Possible Adverse Reaction
November 2010 FDA Approval Of Merck Action Raises Profile Of This Emerging Drug Safety Issue (Posted by Tom Lamb at DrugInjuryWatch.com) As we reported recently, the October 2010 issue of the Canadian Adverse Reaction…
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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®…