Tag: “Dear Doctor” letter
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Syfovre Retinal Vasculitis And Severe Intraocular Inflammation Cases Reported By Ophthalmologists
A July 2023 "Dear Doctor" Letter From Apellis Acknowledges This Developing Syfovre Safety Signal Situation (Posted by Tom Lamb at Drug Injury Watch) UPDATE: From this February 28, 2024, Fierce Pharma news report, "Apellis cites current…
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Elmiron Pigmentary Maculopathy Risk Warning Issued by Janssen and Health Canada in December 2020
New Medical Article Describes How to Identify, Image, and Diagnose Pigmentary Maculopathy Caused by Elmiron Use (Posted by Tom Lamb at Drug Injury Watch) On December 15, 2020 a Dear Healthcare Professional…
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Gilenya Safety Alert November 2020: Cases of Acute Liver Failure Requiring Liver Transplant
European Medicines Agency (EMA) and Novartis Issue Dear Doctor Letter About Gilenya Label Change (Posted by Tom Lamb at DrugInjuryWatch.com) A recent periodic review of Gilenya safety data by the European Medicines…
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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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May 2017 “Dear Doctor” Letter About Aranesp Cases Of Stevens-Johnson Syndrome (SJS) And Toxic Epidermal Necrolysis (TEN)
Current U.S. Version Of Full Prescribing Information Document For Aranesp Mentions Skin Rash Among Other Serious Allergic Reactions (Posted by Tom Lamb at DrugInjuryWatch.com) Aranesp (darbepoetin alfa) products for subcutaneous and intravenous…
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Zecuity Recall: Teva Migraine Drug Patch Gets FDA Warning About Reports Of Serious Burns And Potential Permanent Scarring
Drug Company Announces It Will Recall Zecuity Skin Patches From Pharmacies As Well As Temporarily Suspend Sales, Marketing, And Distribution Of Product (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: Zecuity Migraine…
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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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December 2012 Pradaxa Label Change: Contraindication: Use By Mechanical Heart Valves Patients
A Look At The Events And The Evidence Leading Up To This Latest FDA Action Concerning The Safety Of Pradaxa (Posted by Tom Lamb at DrugInjuryWatch.com) We set the stage with this December 19,…
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Multaq: August 2011 Update: Another Liver Failure Case Report Article In Medical Journal
New Sanofi "Dear Doctor" Letter: Label Change Regarding Heart-Related Side Effects Coming Soon (Posted by Tom Lamb at DrugInjuryWatch.com)This August 2011 update on Multaq (dronedarone) covers both liver injury and cardiovascular side effects. The medical…
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Sanofi-Aventis “Dear Doctor” Letter Will Warn Heart Drug Multaq Associated With Liver Failure
Liver Toxicity And Cardiac Side Effects Cause Dr. Steven Nissen To Express "concerns about the safety, efficacy and tolerability of dronedarone" (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Multaq "safety warning" issued by…