Category: FDA Drug Safety Oversight
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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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Chantix Anti-Smoking Pill: How Significant Is The Heart Risk; Should Chantix Be Recalled
Canadian Medical Journal Article Suggests That The June 2011 Label Change By FDA And Pfizer Is Not Sufficient Measure (Posted by Tom Lamb at DrugInjuryWatch.com) As some may recall, in mid-June 2011 the FDA issued…
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June 2011 FDA Warning About 80 mg Dose Of Zocor, Simvastatin, And Vytorin Cholesterol Medications
Highest Simvastatin Dosage Linked To Potentially Fatal Rhabdomyolysis Muscle Injury And Kidney Failure (Posted by Tom Lamb at DrugInjuryWatch.com) On June 8, 2011 the FDA announced new dosing restrictions for Zocor and other prescription drug…
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Two New Books About Drug Injury Lawsuits, “All The Justice Money Can Buy” and “The Trial”
First Covers One Of The Early Vioxx Cases, Second Is Legal Thriller Fiction With Parallels To Ketek Fiasco (Posted by Tom Lamb at DrugInjuryWatch.com)As the summer reading season draws near, we take a break…
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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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FDA Seeks Information About Topamax-Related Oral Cleft Birth Defect Cases
Request For Historical Incidence Data Made In Connection With NDA For New Obesity Drug (Posted by Tom Lamb at DrugInjuryWatch.com)In mid-January 2011 the biopharmaceutical company Vivus, Inc. — while providing a regulatory update on…
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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…