Category: FDA Drug Safety Oversight
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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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Will The FDA Follow The EMA And Order A Meridia Recall After Its September 2010 Advisory Committee Meeting
NEJM Editorial: There Should Be A Meridia Recall As The Risk Of Heart-Related Side Effects Is Greater Than Any Weight-Loss Benefit (Posted by Tom Lamb at DrugInjuryWatch.com)______________________________________________________________________________ UPDATE: Abbott Pulls Meridia in U.S. Amid FDA Safety…
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Popular Seizure And Bipolar Disorder Medication Lamictal Associated With Aseptic Meningitis In August 2010
FDA Working With GlaxoSmithKline To Update Label, Or Package Insert, And Patient Medication Guide To Warn About This Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com)On August 12, 2010 the FDA announced that Lamictal…
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Mixed Signals About The Safety Of Acne Medication Accutane (Isotretinoin) Continue To Emerge In Summer 2010
FDA Says Accutane Was Not Withdrawn Because Unsafe Drug, While Medical Journal Article Finds Link Between Isotretinoin Therapy And Ulcerative Colitis (Posted by Tom Lamb at DrugInjuryWatch.com)When we last wrote about the acne medication Accutane…
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Zithromax (Azithromycin) And Zmax Associated With Liver Failure And Pyloric Stenosis, Respectively
FDA Is Continuing To Evaluate These Emerging Drug-Safety Issues To Determine Whether Any Regulatory Action Is Needed (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-May 2010 we wrote an article "Zithromax-Induced Liver Injury Case…
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June 2010: FDA Launches Its Postmarketing Drug Safety Evaluations Web Site
New FDA Site Will Include A Summary Analysis Of Recently Reported Adverse Events And Related Medical Articles (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-June 2010 the FDA announced that it will be making…
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Blood Pressure Medication Benicar (Olmesartan) Might Be Unsafe For Some Patients
Two Clinical Studies Find Patients With Type 2 Diabetes Taking Benicar Had Higher Rate Of Death From A Cardiovascular Cause (Posted by Tom Lamb at DrugInjuryWatch.com) On June 11, 2010 the FDA announced that…