Tag: FDA
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Topamax Taken During Pregnancy Associated With A Significant Increased Risk Of Cleft Lip For Infants Born To Those Mothers
Recently Revised Topamax Label Includes Data Of 2014 Annual Report From The North American Antiepileptic Drug (NAAED) Pregnancy Registry (Posted by Tom Lamb at DrugInjuryWatch.com) By means of an October 21, 2014 FDA letter to Janssen Pharmaceuticals,…
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Significantly Increased Risk Of Autism Spectrum Disorder (ASD) In Children Whose Mothers Used Depacon / Depakene / Depakote During Their Pregnancy
August 2014 Label Change By AbbVie Inc. (formerly Abbott) For These Valproate Migraine, Epilepsy/Seizure, And Bipolar Medications Was Done Rather Quietly (Posted by Tom Lamb at DrugInjuryWatch.com)Without much notice, e.g., no FDA Drug Safety Communication was issued,…
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Testosterone Drugs FDA Meeting In September 2014 Reveals That The Safety Of Products Like Axiron, AndroGel, And Testim Is Uncertain Or Unknown At Present Time
Key Advisory Panel Member Concedes It Is Medically Plausible That Testosterone Replacement Therapy Can Be Associated With Heart Attacks / Strokes Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) On September 17, 2014 members of the FDA's…
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Summer 2014 Update: Testosterone “Low-T” Drugs: New FDA Safety Warnings; Recent Medical Journal Article About Heart Risks Of Injectable TRT Products
All Testosterone Therapy Drugs Need To Warn About Blood Clots Side Effects Like DVT And PE; Older Depo-Testosterone Product May Be Safer Than New Gels Such As AndroGel And Testim (Posted by Tom Lamb…
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June 2014 Benicar FDA Drug Safety Communication: Did It Decrease Or Increase Public Concern About The Risk Of Cardiovascular Death
Benicar, Azor, Tribenzor, Benicar HCT, And Other Blood Pressure Medicines Containing Olmesartan: Cardiovascular Mortality In Not A Side Effect Risk, Or Is It (Posted by Tom Lamb at DrugInjuryWatch.com)______________________________________________________________________________ UPDATE: "FDA Once Again Reaches Conclusions At…
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Serious Nerve Damage Side Effect Peripheral Neuropathy Associated With Levaquin, Cipro, And Avelox May Be A Permanent Drug Injury
An August 2013 Label Change Mandated By The FDA For All Fluoroquinolone Antibiotics Was Intended To Raise The Profile Of This Relatively Unknown Risk (Posted by Tom Lamb at DrugInjuryWatch.com) _________________________________________________________________________ UPDATE: Fluoroquinolone Antibiotics…
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For Testosterone Therapy Drugs Like AndroGel / Axiron / Testim: Add “Black-Box” Warning To Label: Public Citizen’s Petition To FDA
Earlier In February 2014 The Endocrine Society Of Medical Doctors Urged Caution In The Prescribing Of These Products To Certain Middle-Aged And Older Men (Posted by Tom Lamb at DrugInjuryWatch.com)On February 25, 2014 a so-called Citizen Petition…
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FDA Drug Safety Concerns About Pradaxa And Serious Bleeding Side Effects Will Get Another Look By Means Of New 2014 Study
A Primary Focus Is Gastrointestinal And Intracranial Hemorrhages In Patients Using Pradaxa For Atrial Fibrillation (Posted by Tom Lamb at DrugInjuryWatch.com)Pradaxa, an anticoagulant drug from Boehringer Ingelheim, was approved by drug regulators in Europe…
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The Pradaxa Gastrointestinal (GI) Bleeding Debate Continues: Is There An Increased Risk Or A Risk Reduction With Pradaxa Use?
A Medical Journal Article About New Meta-Analysis Of Four Pradaxa Trials Shows More GI Bleeds With "New" Blood Thinner Pradaxa Vs. "Old" Warfarin Treatment (Posted by Tom Lamb at DrugInjuryWatch.com) A report published online in November 2013…
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Is Plavix-Related Hemophilia Side Effect Significant Enough For Label Change In Europe But Not In U.S.
Sanofi Has Sent Out "Dear Doctor" Letters About The Association Of Plavix (Clopidogrel) Acquired Hemophilia There — Why Not Here, Too (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: This label revision regarding hemophilia…