Similar Gilenya Drug Label Changes Were Made in Europe and UK During Past Few Months
On January 18, 2021 Health Canada posted a Gilenya drug safety alert about patients developing Gilenya-associated liver injury, including acute liver failure requiring liver transplant. In the final two months of 2020 we saw similar Gilenya liver risk warnings announced by drug regulators in Europe and the United Kingdom (UK).
This Health Canada Dear Healthcare Professional Letter, "GILENYA (fingolimod) - Risk of Liver Injury", presented this Gilenya drug safety issue as follows:
Post-market cases of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have been reported in multiple sclerosis (MS) patients treated with GILENYA. Some of these cases have resulted in acute liver failure requiring a liver transplant.
Health Canada provided some background, as well as adding new information, in that January 2021 Gilenya drug safety alert:
The most recent periodic review of international safety data identified cases of liver failure, some requiring liver transplant, in patients treated with GILENYA. Other cases of clinically significant liver injury were also reported in patients treated with GILENYA. Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have appeared shortly following the initiation of treatment as well as after prolonged use.
During clinical trials, an increase in hepatic enzymes was identified as a very common adverse drug reaction associated with GILENYA. Given the seriousness and severity of recently reported post-market cases, the Canadian Product Monograph (CPM) for GILENYA has been updated to further inform on the risk of liver injury and to include revised guidance for monitoring liver function and criteria for treatment interruption and/or discontinuation.
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We have written about the Gilenya drug label changes with increased liver risk warnings added in Europe and the UK in these previous articles:
- 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
- Gilenya Associated with Cases of Liver Injury, Including Acute Hepatic Failure Requiring Liver Transplant -- January 2021 Drug Safety Update for Gilenya Issued by Medicines and Healthcare products Regulatory Agency
In the US, the Gilenya drug label was revised back in November to add warnings about Gilenya-associated liver injury, including acute liver failure requiring a liver transplant. See 5 WARNINGS AND PRECAUTIONS, 5.5 Liver Injury.
We will watch to see whether the FDA mandates any further Gilenya drug label changes with increased liver risk warnings here in the US going forward.
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