Marketed Human Pharmaceuticals Reported to be Tumorigenic in Rodents

The 1994 U.S. Physicians' Desk Reference reports the results of rodent carcinogenicity tests on 241 pharmaceutical agents. Positive results were reported for 101 agents, with a class label implying a carcinogenic hazard also attached to 9 estrogenic, 4 androgenic, and 3 progestogenic agents. Of the positive agents tested in both rats and mice, 39 of 72 were positive in both species, 22 were positive in rats only, and 11 were positive in mice only. There were few (19) unequivocally genotoxic agents, and only one of these was not reported to be tumorigenic to rodents. The liver was a common target organ in rats and mice. In rats, the other most common target organs for tumors were (in decreasing order) the thyroid, testis, mammary, adrenal, and pituitary. In mice, the only other common target organ was the lung.