Were there any potential safety signals for severe liver injury with orlistat use during clinical trials?
A. No safety concerns for severe liver injury were identified in the clinical trials submitted for the Xenical approval. There were seven clinical studies that involved approximately 2,847 subjects. Of these subjects, 2,153 received at least one year of orlistat treatment and 884 received at least two years of orlistat treatment. Monitoring for liver injury was routinely performed in all seven clinical trials. No significant increases in liver enzymes (a sign of potential severe liver injury) were observed in patients who were taking orlistat compared to those taking a placebo.
