Tag: FDA
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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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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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Another Rather “Odd” YAZ Label Change By Bayer: March 2011
Provides New Warnings About Certain Side Effects As Regards ALL Birth Control Pills (Not Specific To YAZ) (Posted by Tom Lamb at DrugInjuryWatch.com) The bottom line is this: There is nothing specific about YAZ…
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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…
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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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Avandia Recall Decision In Europe To Be Announced On Or About September 23, 2010
Will This September 2010 EMA Committee Meeting Result In A Consensus, Unlike July 2010 FDA Avandia Panel Voting (Posted by Tom Lamb at DrugInjuryWatch.com) _______________________________________________________________________ UPDATE: FDA Keeps Diabetes Pill on Market; Europe Suspends Sales …