Public recall detail

GILENYA (fingolimod) - Risk of Liver Injury

high
Recall Safety notice
Quick summary

Quick summary: GILENYA (fingolimod) - Risk of Liver Injury .

Recommended action

Recommended action: stop using or consuming the product if you believe it matches the recall, review the official details, and follow the instructions from the official source.

Recall details

Quick summary: GILENYA (fingolimod) - Risk of Liver Injury .

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

Brand

Issue

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 liver transplant.

Additional official information
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