This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Bendele, R. A. Articles by Morton, D. M. Search for Related Content PubMed PubMed Citation Articles by Bendele, R. A. Articles by Morton, D. M.

Carcinogenicity Studies of Fluoxetine Hydrochloride in Rats and Mice

Toxicology Research Laboratories, Lilly Research Laboratories, a Division of Eli Lilly and Company, Greenfield, Indiana 46140

¹ To whom requests for reprints should be addressed.

The antidepressant drug fluoxetine HCl was tested for carcinogenicity in three well designed and controlled studies in Fischer rats and C57BL/6 x C3H F₁ mice. The compound was administered to the animals for 24 months at dietary doses of approximately 0, 0.5, 2.0, or 10.0 mg/kg body weight in rats and 1.0, 5.0, or 10.0 mg/kg in mice. The highest dose tested was a maximum tolerated dose for both species as evidenced by clinical signs (rats and mice) and some mortality (mice) referable to central nervous system pharmacological effects, decreased weight gain (rats), and histopathological changes of phospholipidosis (rats) and hepatic fatty change (mice). There was no evidence of an increased incidence of any type of unusual or commonly occurring spontaneous neoplasm in either rats or mice. There were statistically significant decreases in a few commonly occurring neoplasms. The data reported herein provide convincing evidence that fluoxetine is neither a complete carcinogen nor a tumor promoter.

The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked advertisement in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.

Received 9/28/92. Accepted 10/27/92.

This article has been cited by other articles:

				A. Steingart, M. Cotterchio, N. Kreiger, and M. Sloan Antidepressant medication use and breast cancer risk: a case-control study Int. J. Epidemiol., December 1, 2003; 32(6): 961 - 966. [Abstract] [Full Text] [PDF]

				X. Lin, D. A. Levitsky, J. M. King, and T. C. Campbell The promotion effect of anorectic drugs on aflatoxin B1-induced hepatic preneoplastic foci Carcinogenesis, September 1, 1999; 20(9): 1793 - 1799. [Abstract] [Full Text] [PDF]