Tags

Type your tag names separated by a space and hit enter

Antipsychotics and pituitary tumors: an analysis of the European pharmacovigilance database (EudraVigilance).
Int Clin Psychopharmacol. 2019 03; 34(2):89-92.IC

Abstract

One of the possible long-term consequences of antipsychotic-induced hyperprolactinemia is the development of pituitary tumors - prolactinomas. So far, two pharmacovigilance studies of spontaneous adverse event report databases have suggested an increased risk, whereas a longitudinal study carried out with risperidone showed no evidence of increased risk of tumors with mass effect. Besides, information on amisulpride and paliperidone is lacking. Thus, in this study, we aimed to analyze the European pharmacovigilance database (EudraVigilance) to shed light on this issue. We searched for all suspected spontaneous cases of pituitary tumors associated with antipsychotics in EudraVigilance up to 23 March 2017. To assess the association between pituitary tumor cases and each antipsychotic, we calculated the proportional reporting ratios. Among 4 964 866 events of all types recorded in EudraVigilance, we found 292 cases of pituitary tumors associated with antipsychotics. All atypical antipsychotics except clozapine fulfilled the criteria to generate a safety signal. The highest proportional reporting ratio values were found for amisulpride 51.57 (36.3-73.2), risperidone 21.83 (18.4-25.8), and paliperidone 19.95 (14.7-27.1). Sulpiride and haloperidol showed a higher risk among typical antipsychotics 12.4 (5.89-26.1) and 7.0 (4.35-11.3). Notably, we found that a mass effect was present in 16% of the cases. Besides, 18 cases occurred in patients aged below 18 years. Our analysis of the data in EudraVigilance confirms the safety signal detected by previous studies. Interestingly, for the first time, we show that the association seems to be the strongest for amisulpride and that a mass effect was present in around 16% of the cases.

Authors+Show Affiliations

Departments of Pharmacy.Faculty of Pharmacy, University of the Basque Country UPV/EHU, Vitoria-Gasteiz.Internal Medicine, Araba Psychiatric Hospital, Araba Mental Health Network.Department of Psychiatry, Bizkaia Mental Health Network, Portugalete.Basque Pharmacovigilance Unit, Galdakao-Usánsolo Hospital, Galdakao.Basque Pharmacovigilance Unit, Galdakao-Usánsolo Hospital, Galdakao. Department of Pharmacology, School of Medicine and Nursing, University of the Basque Country, Leioa, Spain.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30531551

Citation

Lertxundi, Unax, et al. "Antipsychotics and Pituitary Tumors: an Analysis of the European Pharmacovigilance Database (EudraVigilance)." International Clinical Psychopharmacology, vol. 34, no. 2, 2019, pp. 89-92.
Lertxundi U, Erezuma I, Hernandez R, et al. Antipsychotics and pituitary tumors: an analysis of the European pharmacovigilance database (EudraVigilance). Int Clin Psychopharmacol. 2019;34(2):89-92.
Lertxundi, U., Erezuma, I., Hernandez, R., Medrano, J., Garcia, M., & Aguirre, C. (2019). Antipsychotics and pituitary tumors: an analysis of the European pharmacovigilance database (EudraVigilance). International Clinical Psychopharmacology, 34(2), 89-92. https://doi.org/10.1097/YIC.0000000000000247
Lertxundi U, et al. Antipsychotics and Pituitary Tumors: an Analysis of the European Pharmacovigilance Database (EudraVigilance). Int Clin Psychopharmacol. 2019;34(2):89-92. PubMed PMID: 30531551.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Antipsychotics and pituitary tumors: an analysis of the European pharmacovigilance database (EudraVigilance). AU - Lertxundi,Unax, AU - Erezuma,Itsasne, AU - Hernandez,Rafael, AU - Medrano,Juan, AU - Garcia,Montserrat, AU - Aguirre,Carmelo, PY - 2018/12/12/pubmed PY - 2020/2/19/medline PY - 2018/12/12/entrez SP - 89 EP - 92 JF - International clinical psychopharmacology JO - Int Clin Psychopharmacol VL - 34 IS - 2 N2 - One of the possible long-term consequences of antipsychotic-induced hyperprolactinemia is the development of pituitary tumors - prolactinomas. So far, two pharmacovigilance studies of spontaneous adverse event report databases have suggested an increased risk, whereas a longitudinal study carried out with risperidone showed no evidence of increased risk of tumors with mass effect. Besides, information on amisulpride and paliperidone is lacking. Thus, in this study, we aimed to analyze the European pharmacovigilance database (EudraVigilance) to shed light on this issue. We searched for all suspected spontaneous cases of pituitary tumors associated with antipsychotics in EudraVigilance up to 23 March 2017. To assess the association between pituitary tumor cases and each antipsychotic, we calculated the proportional reporting ratios. Among 4 964 866 events of all types recorded in EudraVigilance, we found 292 cases of pituitary tumors associated with antipsychotics. All atypical antipsychotics except clozapine fulfilled the criteria to generate a safety signal. The highest proportional reporting ratio values were found for amisulpride 51.57 (36.3-73.2), risperidone 21.83 (18.4-25.8), and paliperidone 19.95 (14.7-27.1). Sulpiride and haloperidol showed a higher risk among typical antipsychotics 12.4 (5.89-26.1) and 7.0 (4.35-11.3). Notably, we found that a mass effect was present in 16% of the cases. Besides, 18 cases occurred in patients aged below 18 years. Our analysis of the data in EudraVigilance confirms the safety signal detected by previous studies. Interestingly, for the first time, we show that the association seems to be the strongest for amisulpride and that a mass effect was present in around 16% of the cases. SN - 1473-5857 UR - https://www.unboundmedicine.com/medline/citation/30531551/Antipsychotics_and_pituitary_tumors:_an_analysis_of_the_European_pharmacovigilance_database__EudraVigilance__ L2 - https://doi.org/10.1097/YIC.0000000000000247 DB - PRIME DP - Unbound Medicine ER -