Public recall detail

ESBRIET (pirfenidone) and the Risk of Drug-Induced Liver Injury

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Recall Safety notice
Quick summary

Quick summary: ESBRIET (pirfenidone) and the Risk of Drug-Induced 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: ESBRIET (pirfenidone) and the Risk of Drug-Induced 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

Drug-induced liver injury (DILI) in the form of transient and clinically silent elevations in transaminases has been commonly reported in patients treated with ESBRIET. Rare DILI cases have been associated with serious clinical consequences including isolated cases with fatal outcome.

Additional official information
AudienceHealthcare professionals including respirologists, prescribing physicians, emergency room physicians, and selected pharmacists.
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Companies
AudiencesHealthcare professionals including respirologists, prescribing physicians, emergency room physicians, and selected pharmacists.

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