Category: FDA Drug Safety Oversight
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Cardiovascular Safety Issues For Onglyza And Kombiglyze Will Be Discussed At April 2015 FDA Advisory Committee Meeting
These Two New AstraZeneca Diabetes Medications With Saxagliptin Are Part Of The Incretin Mimetic Class Of Drugs (Posted by Tom Lamb at DrugInjuryWatch.com)At an April 14, 2015 meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, results of the…
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Various Drug Safety Issues Continue To Be Associated With Novartis Multiple Sclerosis (MS) Medication Gilenya
ISMP QuarterWatch Report From 2014 States Adverse Events Reports Show That Gilenya Cardiac Risks "were neither rare nor hypothetical" (Posted by Tom Lamb at DrugInjuryWatch.com)The safety profile for the Novartis drug Gilenya (fingolimod) has been controversial for…
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Xolair Is Associated With Higher Than Expected Reporting Of Arterial Thrombotic Events Such As Strokes And Cardiovascular Deaths
While European Drug Regulators Have Been Concerned About This Aspect Of Xolair Safety, FDA Has No Warning About Arteriothrombotic Risks Of Xolair (Posted by Tom Lamb at DrugInjuryWatch.com)In September 2014 the FDA issued an update about its…
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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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Xolair Asthma Drug Associated With Higher Rate Of Heart Attacks, Pulmonary Hypertension, Blood Clots Causing PEs And/Or DVTs, And Brain Blood Vessel Problems
Since FDA Early Communication About An Ongoing Safety Review Of Xolair Was Issued In 2009, The Agency Has Been Examining Xolair Safety Profile But FDA Is Still Unsure If This Drug Is Safe Or…
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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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July 2014 Boxed Warning For Linzess: Irritable Bowel Syndrome / Constipation Drug May Be Unsafe And Cause Diarrhea In Children
FDA Drug Alert Warns That Linzess Should Not Be Used In Children Under Age 6 And Neither Safety Nor Efficacy Established For Those Under 18 Years Old (Posted by Tom Lamb at DrugInjuryWatch.com) …
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AndroGel / Axiron / Testim: Heart Attacks, Strokes, And Other Cardiovascular Problems Will Be Subject Of FDA Advisory Panel Meeting In September 2014
Health Canada Orders Label Change For Testosterone Drugs In July 2014: Must Warn About Increased Risks Of Side Effects Including Blood Clots, DVTs, PEs (Posted by Tom Lamb at DrugInjuryWatch.com)The safety issues concerning the popular…
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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…