Xarelto: Drug-Induced Liver Injury Warning Should Be Added To Drug Label...
Medical Journal Article Reports On Two Patients Who Experienced Severe Liver Damage Onset During Xarelto Treatment SUMMARY: A recent article published by the medical journal JAMA Internal Medicine,...
View ArticleMultiple Myeloma Drug Pomalyst Associated With Side Effects Risks Of Cardiac...
In May 2015 The Medicines and Healthcare Products Regulatory Agency In UK Issued A Drug Safety Update; Will There Be Similar FDA Action? SUMMARY: Pomalidomide (brand name: Pomalyst in the US; Imnovid...
View ArticleHep C Drugs Viekira Pak And Technivie: FDA Warnings About Liver Injury
On October 22, 2015 the FDA issued this announcement, “Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication – Risk of Serious Liver Injury”, from which we get this warning...
View ArticleRisk of Hepatitis B Reactivation Associated With Gleevec And Iclusig
Currently available medicines in the BCR-ABL TKIs class of drugs include Gleevec and Iclusig, as well as Tasigna, Bosulif, and Sprycel. These BCR-ABL tyrosine kinase inhibitors (TKIs) are used for the...
View ArticleWarnings About Significant Liver Injury Added To Tecfidera Drug Label
In January 2017 liver injury was added to the Warnings and Precautions part of the Prescribing Information document, or drug label, for Tecfidera (dimethyl fumarate), which was approved by the FDA in...
View ArticleSovaldi / Harvoni: “Black-Box” Warning About Hepatitis B Reactivation
In February 2017 a so-called “black-box” warning was added to the drug labels for Harvoni, Sovaldi, Technivie, Viekira Pak, and other direct-acting antivirals, warning doctors and patients that cases...
View ArticlePradaxa Liver Injury: Label Changes Warning About This Increased Risk
We are watching to see whether the FDA and/or European drug regulators require a Pradaxa liver injury label change adding a new warning about an increased risk of acute liver failure and drug-induced...
View ArticleEsmya and Risk of Serious Liver Injury: UK Drug Regulator Issues Safety Alert...
In early August 2018 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued an alert to healthcare professionals concerning the risk of serious liver damage from Esmya (ulipristal...
View ArticleLemtrada Safety Issues Lead To Use Restrictions In Europe
Drug safety regulators for the European Union recently recommended that Lemtrada use be restricted to certain limited patient populations due to serious side effects linked to Lemtrada. This November...
View ArticleLemtrada-Related Cardiovascular Reactions And Immune-Mediated Reactions
Lemtrada (alemtuzumab) is a monoclonal antibody (mAb) authorized for the treatment of adults with relapsing-remitting multiple sclerosis (MS). Some recent significant safety findings for this MS drug...
View ArticleXarelto: Drug-Induced Liver Injury Warning Should Be Added To Drug Label...
Medical Journal Article Reports On Two Patients Who Experienced Severe Liver Damage Onset During Xarelto Treatment SUMMARY: A recent article published by the medical journal JAMA Internal Medicine,...
View ArticleMultiple Myeloma Drug Pomalyst Associated With Side Effects Risks Of Cardiac...
In May 2015 The Medicines and Healthcare Products Regulatory Agency In UK Issued A Drug Safety Update; Will There Be Similar FDA Action? SUMMARY: Pomalidomide (brand name: Pomalyst in the US; Imnovid...
View ArticleHep C Drugs Viekira Pak And Technivie: FDA Warnings About Liver Injury
On October 22, 2015 the FDA issued this announcement, “Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication – Risk of Serious Liver Injury”, from which we get this warning...
View ArticleRisk of Hepatitis B Reactivation Associated With Gleevec And Iclusig
Currently available medicines in the BCR-ABL TKIs class of drugs include Gleevec and Iclusig, as well as Tasigna, Bosulif, and Sprycel. These BCR-ABL tyrosine kinase inhibitors (TKIs) are used for the...
View ArticleWarnings About Significant Liver Injury Added To Tecfidera Drug Label
In January 2017 liver injury was added to the Warnings and Precautions part of the Prescribing Information document, or drug label, for Tecfidera (dimethyl fumarate), which was approved by the FDA in...
View ArticleSovaldi / Harvoni: “Black-Box” Warning About Hepatitis B Reactivation
In February 2017 a so-called “black-box” warning was added to the drug labels for Harvoni, Sovaldi, Technivie, Viekira Pak, and other direct-acting antivirals, warning doctors and patients that cases...
View ArticlePradaxa Liver Injury: Label Changes Warning About This Increased Risk
We are watching to see whether the FDA and/or European drug regulators require a Pradaxa liver injury label change adding a new warning about an increased risk of acute liver failure and drug-induced...
View ArticleEsmya and Risk of Serious Liver Injury: UK Drug Regulator Issues Safety Alert...
In early August 2018 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued an alert to healthcare professionals concerning the risk of serious liver damage from Esmya (ulipristal...
View ArticleLemtrada Safety Issues Lead To Use Restrictions In Europe
Drug safety regulators for the European Union recently recommended that Lemtrada use be restricted to certain limited patient populations due to serious side effects linked to Lemtrada. This November...
View ArticleLemtrada-Related Cardiovascular Reactions And Immune-Mediated Reactions
Lemtrada (alemtuzumab) is a monoclonal antibody (mAb) authorized for the treatment of adults with relapsing-remitting multiple sclerosis (MS). Some recent significant safety findings for this MS drug...
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