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Follow-up study of a pharmacovigilance signal: no evidence of increased risk with risperidone of pituitary tumor with mass effect.
J Clin Psychopharmacol. 2012 Dec; 32(6):743-9.JC

Abstract

INTRODUCTION

Pharmacovigilance studies of spontaneous adverse event report databases are used to raise hypotheses about potential safety events. Such studies have found a disproportionately higher number of pituitary tumor reports for risperidone. Because there is a high prevalence of clinically "silent" pituitary adenomas, any increased workup in risperidone users, for example, secondary to hyperprolactinemia, might account for the increased reports. We undertook a detailed study of medical record-confirmed newly diagnosed pituitary tumors with mass effect in patients prescribed antipsychotics to evaluate the effect of risperidone.

METHODS

We conducted retrospective studies in 2 large administrative health care databases with access to medical records. Patients were classified into risperidone or other atypical antipsychotic exposure groups. Records with administrative codes indicative of possible cases in the follow-up period were reviewed to confirm the diagnosis of new pituitary tumor and presence of mass effects.

RESULTS

The hazard ratio of confirmed pituitary tumors with mass effect was 1.0 (95% confidence interval, 0.5-1.9). Whereas the precision of the hazard ratio was limited by low event rates, despite examination of 409,823 patients' records, ancillary analyses supported the interpretation of no elevated risk. Evidence was found for detection bias that may explain previous pharmacovigilance findings.

DISCUSSION

There was no evidence of increased risk of pituitary tumor with mass effect with risperidone in either cohort or case-control analyses. We cannot rule out a small risk (<2-fold), or a risk that may develop with additional years of exposure or follow-up, or a risk of microadenomas or prolactinomas.

Authors+Show Affiliations

Department of Veterans Affairs, Veterans Health Administration, Pharmacy Benefits Management Services, Hines, IL 60141, USA. madeline.mccarren@va.govNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23131882

Citation

McCarren, Madeline, et al. "Follow-up Study of a Pharmacovigilance Signal: No Evidence of Increased Risk With Risperidone of Pituitary Tumor With Mass Effect." Journal of Clinical Psychopharmacology, vol. 32, no. 6, 2012, pp. 743-9.
McCarren M, Qiu H, Ziyadeh N, et al. Follow-up study of a pharmacovigilance signal: no evidence of increased risk with risperidone of pituitary tumor with mass effect. J Clin Psychopharmacol. 2012;32(6):743-9.
McCarren, M., Qiu, H., Ziyadeh, N., Jiang, R., Wang, Y., & McAfee, A. T. (2012). Follow-up study of a pharmacovigilance signal: no evidence of increased risk with risperidone of pituitary tumor with mass effect. Journal of Clinical Psychopharmacology, 32(6), 743-9. https://doi.org/10.1097/JCP.0b013e318271069d
McCarren M, et al. Follow-up Study of a Pharmacovigilance Signal: No Evidence of Increased Risk With Risperidone of Pituitary Tumor With Mass Effect. J Clin Psychopharmacol. 2012;32(6):743-9. PubMed PMID: 23131882.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Follow-up study of a pharmacovigilance signal: no evidence of increased risk with risperidone of pituitary tumor with mass effect. AU - McCarren,Madeline, AU - Qiu,Hong, AU - Ziyadeh,Najat, AU - Jiang,Rong, AU - Wang,Yu, AU - McAfee,Andrew T, PY - 2012/11/8/entrez PY - 2012/11/8/pubmed PY - 2013/8/27/medline SP - 743 EP - 9 JF - Journal of clinical psychopharmacology JO - J Clin Psychopharmacol VL - 32 IS - 6 N2 - INTRODUCTION: Pharmacovigilance studies of spontaneous adverse event report databases are used to raise hypotheses about potential safety events. Such studies have found a disproportionately higher number of pituitary tumor reports for risperidone. Because there is a high prevalence of clinically "silent" pituitary adenomas, any increased workup in risperidone users, for example, secondary to hyperprolactinemia, might account for the increased reports. We undertook a detailed study of medical record-confirmed newly diagnosed pituitary tumors with mass effect in patients prescribed antipsychotics to evaluate the effect of risperidone. METHODS: We conducted retrospective studies in 2 large administrative health care databases with access to medical records. Patients were classified into risperidone or other atypical antipsychotic exposure groups. Records with administrative codes indicative of possible cases in the follow-up period were reviewed to confirm the diagnosis of new pituitary tumor and presence of mass effects. RESULTS: The hazard ratio of confirmed pituitary tumors with mass effect was 1.0 (95% confidence interval, 0.5-1.9). Whereas the precision of the hazard ratio was limited by low event rates, despite examination of 409,823 patients' records, ancillary analyses supported the interpretation of no elevated risk. Evidence was found for detection bias that may explain previous pharmacovigilance findings. DISCUSSION: There was no evidence of increased risk of pituitary tumor with mass effect with risperidone in either cohort or case-control analyses. We cannot rule out a small risk (<2-fold), or a risk that may develop with additional years of exposure or follow-up, or a risk of microadenomas or prolactinomas. SN - 1533-712X UR - https://www.unboundmedicine.com/medline/citation/23131882/Follow_up_study_of_a_pharmacovigilance_signal:_no_evidence_of_increased_risk_with_risperidone_of_pituitary_tumor_with_mass_effect_ L2 - https://doi.org/10.1097/JCP.0b013e318271069d DB - PRIME DP - Unbound Medicine ER -