Tag: drug safety
-
Waiting To See Whether FDA Approves Zelnorm In 2018 After Zelnorm Was Withdrawn In 2007 For Safety Reasons
Earlier Zelnorm Recall Was Due To Potential Cardiovascular Safety Signal, With Suicidal Ideation And Behavior Being Another Issue (Posted by Tom Lamb at DrugInjuryWatch.com) On October 17, 2018 the FDA’s Gastrointestinal Drugs…
-
Newer Diabetes Drugs Side Effect: Fournier’s Gangrene, Serious Infection Of Genital Area
FDA Mandates Label Changes With New Warnings For Invokana, Farxiga, Jardiance, Other SGLT2 Inhibitors (Posted by Tom Lamb at DrugInjuryWatch.com) In late August 2018 the FDA warned doctors and patients that cases…
-
Pradaxa-Related Liver Injury: Health Canada’s Drug Safety Review Of Pradaxa Concludes There Is A Link
Remains Unknown Whether Pradaxa Label Change About Liver Damage In Canada Will Be Followed By Similar FDA Action In US (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2018 Health Canada announced…
-
Gout Drug Uloric Recall By FDA Requested In June 2018 Public Citizen Petition Letter
Consumer Group Contends That The Evidence Of Harmful Uloric Side Effects Outweighs Any Real Benefit To Patients (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA should order Takeda Pharmaceuticals to immediately withdraw from…
-
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…
-
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…
-
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…
-
Jardiance – Amputations Drug Safety Issue Remains Uncertain Due To Admitted “inherent limitations of… post hoc analyses”
Jardiance Seemingly Not Associated With Amputations Per Reexamination Of Drug Company Funded EMPA-REG OUTCOME® Trial Data (Posted by Tom Lamb at DrugInjuryWatch.com) In April 2016 the European Medicines Agency (EMA) warned that…
-
Medical Researchers Continue To Study Bladder Cancer As A Possible Side Effect Of Jardiance
New Analysis Finds Significant Increased Risk Of Bladder Cancer For SGLT2 Inhibitors With Empagliflozin (Posted by Tom Lamb at DrugInjuryWatch.com) For years there has been a lingering concern over whether Sodium-Glucose Co-Transporter-2…
-
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…