Nomination Summary for Clarithromycin (N99022)
Nominated Substances: Clarithromycin
Nomination Date: 05/19/1999
Nominator: FDA
Rationale: Used in the treatment of mild to moderate infections caused by specific microorganisms. Hepatotoxicity, testicular atrophy, lymphoid depletion and renal tubular degeneration were observed in rats, dogs, and monkeys exposed to Clarithromycin. Lack of carcinogenicity data; current use patterns and rapid absorption and distribution into body tissues