Tag: FDA
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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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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,…
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August 2017 ED Drugs Label Change Warns That Some Users Of Cialis, Levitra, And Viagra Have Developed NAION Vision Loss
There Is An Approximate Two Times Increased Risk Of NAION According To Recent Medical Study, Which Is Consistent With Some Earlier Medical Research (Posted by Tom Lamb at DrugInjuryWatch.com) As reported previously,…
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Analysis Of FDA Adverse Event Reports Describes Extent And Nature of Invokamet / Invokana – Amputation Side Effect
This New Medical Research Was Published Just Before “Black-Box Warning” About Lower Limb Amputations Added To Drug Labels (Posted by Tom Lamb at DrugInjuryWatch.com) In the final week of July 2017, the…
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European Drug Regulator EMA Suspends Use Of MRI Drugs Magnevist, Omniscan, And OptiMARK In July 2017
The Drug Safety Concern Is That Use Of These Gadolinium Contrast Agents Can Leave Gadolinium Deposits In Brain Tissues (Posted by Tom Lamb at DrugInjuryWatch.com) The European Medicines Agency (EMA) recently announced…
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Invokana – Amputation Side Effect Gets “Black-Box Warning” On Revised Drug Label Issued In July 2017
This Label Change Was Previewed In A May 2017 FDA Drug Safety Communication About Increased Risk Of Leg And Foot Amputations (Posted by Tom Lamb at DrugInjuryWatch.com) A June 2017 article, “Invokana…