Category: Drug Safety Alerts
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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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Actos And Avandia Use Associated With Diabetic Macular Edema, Which Can Lead To Blindness
New UK Study Found Three To Six Times Increased Risk Of Developing This Retinal Eye Disease Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Avandia, Actos May Raise Risk of Macular Edema…
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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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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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Acute Pancreatitis Case Associated With Victoza Use, Similar To Byetta And Januvia Case Reports
Drug Safety Issue Controversy Continues: True Serious Side Effect, Or Attributable To Type 2 Diabetes Condition (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Victoza (liraglutide [rDNA origin]) Injection: REMS – Risk of Thyroid…
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Bayer Affirms Safety Of YAZ / Yasmin And Refutes 2011 BMJ Articles About Risk Of Blood Clots
Just As It Did In 2010 Label Change, Bayer Contends New Medical Studies Are Less Reliable Than Other VTE Evidence (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: New research suggests that women who…
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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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Topamax During Pregnancy Increases Risk Of Cleft Lip And/Or Cleft Palate Birth Defects
Oral Clefts In Babies Are 20 Times More Likely With Women Who Used Topamax (topiramate) After Getting Pregnant (Posted by Tom Lamb at DrugInjuryWatch.com) In early March 2011 the FDA announced that the prescribing information…
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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…