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MS Drugs Ocrevus and Gilenya Linked to Melanoma, Other Skin Cancers

April 15, 2022 By Law Offices of Thomas J. Lamb, P.A.

Multiple sclerosis (MS) drugs Ocrevus and Gilenya have been linked to melanoma, with Gilenya linked to squamous cell carcinoma and basal cell carcinoma, also. These new drug safety findings come from an analysis of skin cancer cases reported to the FDA Adverse Event Reporting System (FAERS) for patients receiving certain multiple sclerosis (MS) … [Read more...]

Filed Under: Unsafe Drugs Tagged With: basal cell carcinoma, Gilenya, Lemtrada, Mayzent, melanoma skin cancer, Ocrevus, skin cancers, squamous cell carcinoma

Gilenya Label Change with New Liver Injury Risk Warnings in Canada

January 22, 2021 By Law Offices of Thomas J. Lamb, P.A.

In the final two months of 2020, we saw a Gilenya label change adding new liver risk warnings announced by drug regulators in Europe, first, and the United Kingdom (UK), later.  Next, in January 2021, Health Canada posted a Gilenya drug safety alert about patients developing Gilenya-associated liver injury, including acute liver failure … [Read more...]

Filed Under: Unsafe Drugs Tagged With: Gilenya, liver failure, liver injury

Gilenya Linked To Acute Liver Failure, Drug-induced Liver Injury

November 13, 2020 By Law Offices of Thomas J. Lamb, P.A.

As reported in this European Medicines Agency (EMA) periodic safety update report, “Gilenya (fingolimod): Updated recommendations to minimise the risk of drug-induced liver injury (DILI)”, published November 10, 2020, there have been cases of Gilenya-related liver failure and drug-induced liver injury associated with Gilenya. A Direct Healthcare … [Read more...]

Filed Under: Unsafe Drugs Tagged With: drug-induced liver injury, Gilenya, liver failure, liver injury

Warning About Gilenya Birth Defects From Health Canada In December 2019

December 24, 2019 By Law Offices of Thomas J. Lamb, P.A.

This December 2019 Health Canada warning about Gilenya birth defects, ” “GILENYA (fingolimod) – Risk of Congenital Malformations”, starts with these two points: When used during pregnancy, GILENYA (fingolimod) has been associated with an increased risk of major congenital malformations, including congenital heart disease such as atrial septal … [Read more...]

Filed Under: Unsafe Drugs Tagged With: birth defects, congenital birth defects, congenital heart defects, Gilenya

EU Calls for Strengthened and Revised Warnings for MS Drug Gilenya

December 19, 2017 By Law Offices of Thomas J. Lamb, P.A.

UPDATE:  On December 15, 2017, the FDA released an updated drug label for Gilenya with increased warnings. (12/27/17). Background After conducting a routine review of the immunosuppressive drug Gilenya (fingolimod), the Medicines and Healthcare Products Regulatory Agency (MHRA) recently suggested that the drug label for Gilenya be … [Read more...]

Filed Under: Unsafe Drugs Tagged With: cardiovascular events, drug label warnings, EMA, EU, European Medicines Agency, FDA, fingolimod, food and drug administration, Gilenya, gilenya side effects, immunosuppressive drugs, lymphoma, MHRA, MS drugs, multiple sclerosis drugs, pml, serious infections, skin cancers

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