Carcinogenicity of psychotropic drugs: A systematic review of US Food and Drug Administration-required preclinical in vivo studies.
OBJECTIVE
The US Food and Drug Administration approval process for psychotropic drugs requires safety studies of carcinogenicity in animals. These studies are consistently conducted and provide a database for assessment of potential biological risk of carcinogenicity in humans. This report is a systematic review of that database for psychotropic drugs.


METHODS
US Food and Drug Administration-approved registration data ('package inserts') were examined, where available, for all psychotropic drugs in the following classes: antidepressants, antipsychotics, benzodiazepines/sedative-hypnotics, amphetamines and anticonvulsants.


RESULTS
Overall, new generation (atypical) antipsychotics (90%, 9/10 agents) and anticonvulsants (85.7%, 6/7 agents) showed the highest evidence of carcinogenicity among psychotropic drugs classes assessed. Antidepressants (63.6%, 7/11) and benzodiazepines/sedative-hypnotics (70%, 7/10) were next, and stimulants (with the exception of methylphenidate) were last (25%, 1/4 agents). Overall, 71.4% of all drugs examined (30/42) showed evidence of carcinogenicity in 43.2% (38/88) of specific experimental studies.


CONCLUSIONS
US Food and Drug Administration-based analyses demonstrate that almost all atypical antipsychotics and anticonvulsants are carcinogenic in animals, as are the majority of antidepressants and benzodiazepines and methylphenidate. These animal-based results are not sufficient to draw definitive conclusions in humans, but they provide data that could be acknowledged in the informed consent process of clinical treatment.
Section of Psychiatry, Department of Neuroscience, University of Parma, Parma, Italy Mood Disorders Program, Tufts Medical Center, Boston, MA, USA andrea.amerio@studenti.unipr.it.
Andrea
A
Amerio
Mood Disorders Program, Tufts Medical Center, Boston, MA, USA Javeriana University School of Medicine, Bogotá, Colombia.
Juan Francisco
JF
Gálvez
Public Health Unit, School of Medicine, University of Parma, Parma, Italy Department of Global Health & Social Medicine, Harvard Medical School, Boston, MA, USA.
Anna
A
Odone
Department of Clinical Psychology, Roosevelt University, Chicago, IL, USA.
Shannon A
SA
Dalley
Mood Disorders Program, Tufts Medical Center, Boston, MA, USA Tufts University School of Medicine, Boston, MA, USA.
S Nassir
SN
Ghaemi
D000818:Animals; D015197:Carcinogenicity Tests; D004353:Drug Evaluation, Preclinical; D006801:Humans; D011619:Psychotropic Drugs / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration
D011619:Psychotropic Drugs
Food and Drug Administration; Psychotropic drugs; carcinogenicity; preclinical studies