FDAsafety guidance72% confidence
Hepatitis C Medicines (Mavyret, Zepatier, and Vosevi): Drug Safety Communication - Due to Rare Occurrence of Serious Liver Injury in Some patients with Advanced Liver Disease
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ild) as Boehringer Ingelheim.
Regulatory Analysis
FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure.
Supporting Context
- Therapeutic area
- Pulmonology · Pulmonary Fibrosis
- Sub-indication
- Ild
Related signal: Boehringer Ingelheim Initiates Long-term Study of Nerandomilast in Pulmonary Fibrosis Patients