Drugs and cancer: an analysis of the French Pharmacovigilance Database.

BACKGROUND

Our knowledge on cancers related to drugs remains limited. Among the different pharmacoepidemiological approaches assessing this risk, analysis of reports to pharmacovigilance (PV) system is uncommon.

OBJECTIVES

To review cancers registered as adverse drug reactions (ADRs) in the French Pharmacovigilance Database (FPVDB).

METHODS

This study was based on spontaneous reports of ADRs submitted to the French PV system. All cases of cancers reported in the FPVDB between 1995 and 2006 were reviewed. Cases with transgenerational effects, cases from patients with an history of primary cancer and cancers associated with antineoplastic drugs were excluded. Drugs were classified according ATC classification. Results. Out of 207 000 notifications, 414 cases of cancer (998 citations of drugs) were identified. Report s increased from 19 cases in 1995 to 70 in 2006. Patients' age ranged from 2 to 95 years. Gender was equally distributed. Most frequently reported cancers were lymphomas (22.7%), b asal or squamous cell carcinomas (16.4%) and leukemias (13.8%). Immunosuppressants (37.6%) were ranked in the first position followed by corticosteroids (9.3%). Potential drug-cancer associations, previously described in the literature (immunosuppressants, hydroxycarbamide, mitoxantrone, cyproterone and hormone replacement therapy) were found in the database. Other potential drug-cancer associations (leukemia and non-Hodgkin's lymphoma after exposition to nucleoside reverse-transcriptase inhibitors or interferon) were also identified.

CONCLUSIONS

Cancer notifications in a PV database, although usually considered as poorly generalizable to the general population, appears to be useful in the surveillance of cancer risk associated to drugs. It allows both confirmation of already known data and detection of new signals. Combination of present data with pharmacoepidemiological studies and collaborations with cancer registries would allow better identification of these risk signals.