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. Method: US Food and Drug Administration-approved registration data (â package insertsâ (tm)) 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.

Carcinogenicity of psychotropic drugs: A systematic review of US Food and Drug Administration-required preclinical in vivo studies / Amerio, Andrea; Gálvez, Juan Francisco; Odone, Anna; Dalley, Shannon A; Ghaemi, S. Nassir. - In: AUSTRALIAN AND NEW ZEALAND JOURNAL OF PSYCHIATRY. - ISSN 0004-8674. - 49:8(2015), pp. 686-696. [10.1177/0004867415582231]

Carcinogenicity of psychotropic drugs: A systematic review of US Food and Drug Administration-required preclinical in vivo studies

AMERIO, Andrea;ODONE, Anna;
2015-01-01

Abstract

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. Method: US Food and Drug Administration-approved registration data (â package insertsâ (tm)) 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.
Carcinogenicity of psychotropic drugs: A systematic review of US Food and Drug Administration-required preclinical in vivo studies / Amerio, Andrea; Gálvez, Juan Francisco; Odone, Anna; Dalley, Shannon A; Ghaemi, S. Nassir. - In: AUSTRALIAN AND NEW ZEALAND JOURNAL OF PSYCHIATRY. - ISSN 0004-8674. - 49:8(2015), pp. 686-696. [10.1177/0004867415582231]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2817733
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