Category: FDA Drug Safety Oversight
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Tasigna Side Effects Include Ischemic Cerebrovascular Events, Ischemic Heart Disease, And Peripheral Arterial Occlusive Disease
Less Warning About These Atherosclerosis-Related Diseases By Novartis In The US, It Seems, Compared To What Has Been Done By The Drug Company In Canada (Posted by Tom Lamb at DrugInjuryWatch.com) Tasigna…
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Ocaliva Black-Box Warning About Liver Failure Due To Incorrect Doses Added In Early 2018
This Ocaliva Label Change Follows September 2017 Dear Doctor Letter Sent By Intercept Pharmaceuticals (Posted by Tom Lamb at DrugInjuryWatch.com) An earlier blog post, "Will Ocaliva Get Black-Box Warning For Liver Injury…
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Drug-Induced Liver Injury Warning Added To OFEV Label In Canada As Done Earlier In US
This Relatively New Idiopathic Pulmonary Fibrosis (IPF) Pill Is Clearly On The Radar Of Drug Safety Regulators (Posted by Tom Lamb at DrugInjuryWatch.com) OFEV (nintedanib) capsules were approved by the FDA in 2014…
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Gadolinium-Containing Contrast Agents Omniscan And Magnevist Being Recalled In The United Kingdom In February 2018
In Comparison, This December 2017 Regulatory Action By FDA In The US: “new class warning… for all gadolinium-based contrast agents” (Posted by Tom Lamb at DrugInjuryWatch.com) There seems to be a consensus…
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FDA Recommends A Recall For Limbrel “Medical Food” Product But Primus Pharmaceuticals Is Not Complying
Reports Of Drug-Induced Liver Injury And Hypersensitivity Pneumonitis Are At Center Of This Unusual Drug Safety Controversy (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: Primus Pharmaceuticals Inc. Finally Removes Its Osteoarthritis Capsule Limbrel…
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New Heart Failure Drug Entresto Apparently Has Safety Signal For Hypotension (Low Blood Pressure) Side Effect
Will Recent ISMP QuarterWatch Report Prompt FDA Regulatory Action, Including Possible Drug Label Change By Novartis? (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA approved Entresto™ (sacubitril and valsartan) tablets in July…
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Association Of Melanoma With Viagra, Cialis, Other PDE-5 Drugs: Fall 2017 Review Of Recent Medical Articles
FDA Investigation Of Potential Link Between Melanoma Skin Cancer And ED Drugs As Well BPH And PAH Medicines Continues (Posted by Tom Lamb at DrugInjuryWatch.com) From this FDA watch list of drugs…
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Viberzi – Pancreatitis Side Effects Can Develop At Any Time While Taking This IBS Drug, According To FDA Safety Warning
Severe Cases Of Pancreatitis And Sphincter Of Oddi Spasm Reported Even After Just The First Dose Of Viberzi, With Some Resulting In Patient Deaths (Posted by Tom Lamb at DrugInjuryWatch.com) In March…
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Potential Safety Signal: Rhabdomyolysis May Be Linked To Onglyza, Nesina, Januvia, And Other Diabetes Drugs
FDA Was Already Investigating The Dipeptidyl Peptidase IV (DPP-IV) Inhibitor Class Of Diabetes Drugs For Kidney Or Renal Failure (Posted by Tom Lamb at DrugInjuryWatch.com) According to a new FDA quarterly report,…