Category: FDA Drug Safety Oversight
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Blood Thinner Pradaxa Linked To More Cases Of Serious Bleeding Events And New FDA Study Confirms Increased Risk Of GI Bleeds Compared To Warfarin
More Than 2000 Pradaxa Lawsuits Have Been Filed Against Boehringer, And A Company Official Has Admitted That More Than 1400 Patients Bled To Death (Posted by Tom Lamb at DrugInjuryWatch.com)______________________________________________________________________________ UPDATE: Boehringer Pays $650 Million…
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Possible Link Between Heart Failure And Onglyza Diabetes Type 2 Drug Is Being Investigated By FDA, As Announced In February 2014
This Cardiovascular Side Effect Issue Also Involves Kombiglyze XR, A Saxagliptin – Metformin Combo Diabetes Medication (Posted by Tom Lamb at DrugInjuryWatch.com)AstraZeneca's diabetes drugs Onglyza and Kombiglyze, both of which contain the active ingredient saxagliptin,…
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Like Depakote, Stavzor Can Cause Liver Failure, Usually During First 6 Months; Children Under Age 2 Are At A Higher Risk, As Are Patients with Mitochondrial Disease
Black-Box Warning Added To Stavzor Label Announced By FDA In March 2014, Almost Full Year After Similar Label Change For Depakote Hepatotoxicity (Posted by Tom Lamb at DrugInjuryWatch.com)Stavzor, a lesser known valproic acid medication…
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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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Antidepressant-Related Birth Defect: Heart And Lung Disorder PPHN – Persistent Pulmonary Hypertension Of The Newborn
Increased Risk Of PPHN When Women Use SSRIs Medications Like Celexa, Lexapro, Paxil, Prozac, And Zoloft After Their 20th Week Of Pregnancy (Posted by Tom Lamb at DrugInjuryWatch.com) A recent medical journal article, "Prenatal…
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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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Pfizer’s Lipitor Statin Drug For Treatment Of High Cholesterol Linked To An Increased Risk Of Type-2 Diabetes In Some Older And Post-Menopausal Women
February 2012 FDA Drug Safety Warning About Lipitor Label Change Concerning New-Onset Diabetes Mellitus (DM) Has Gone Largely Unnoticed To Date (Posted by Tom Lamb at DrugInjuryWatch.com)Statins are a class of prescription drugs used…
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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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Flomax Can Cause Severe Hypotension According To A New Medical Study Article Published In November 2013 BMJ Journal
Low Blood Pressure Can Lead To Loss Of Consciousness / Fainting With A Fall Down Resulting In Injury And Hospital Admission (Posted by Tom Lamb at DrugInjuryWatch.com) Flomax® (tamsulosin) received its initial FDA approval…
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October 2013 NuvaRing Label Change: Warnings And Precautions Section Sets Forth Two Competing Medical Studies About Side Effects
In Addition, The New Package Insert No Longer States It Is Unknown If NuvaRing Has A Different Blood Clot (VTE) Risk Than Some Birth Control Pills (Posted by Tom Lamb at DrugInjuryWatch.com) On October…