FDA adds liver injury warning to PYRUKYND label for PK deficiency

AGIOS PHARMACEUTICALS, INC.

FDA approved update to PYRUKYND USPI: liver injury observed in patients with another condition at higher doses.
New Warnings: obtain liver tests before initiation, monthly for first 6 months, interrupt if ALT >5x ULN.
All patients with liver injury discontinued PYRUKYND and improved upon discontinuation.
Adverse Reactions section updated to reflect hepatocellular injury in another condition.

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