α1-Adrenergic receptor antagonists and gynecomastia. A case series from the Italian spontaneous reporting system and VigiBase™

Viola, Ermelinda; Opri, Sibilla; Moretti, Ugo; Leone, Roberto; Casini, Maria Luisa; Ruggieri, Sara; Minore, Claudia; Conforti, Anita

doi:10.1007/s00228-014-1700-3

Cited by 6 publications

(3 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The patient was also taking tamsulosin, a potential cause of gynecomastia. 3 However, gynecomastia did not recur when he was no more exposed to atorvastatin even though tamsulosin was continued. It is also unlikely that the androgen-receptor abnormalities caused by the previous treatment with bicalutamide could be present many years later and play a role in the development of gynecomastia.…”

Section: To the Editormentioning

confidence: 96%

Atorvastatin-Associated Gynecomastia

Famularo¹,

Sarrecchia²

2021

Ann Pharmacother

View full text Add to dashboard Cite

Section: To the Editormentioning

confidence: 96%

Atorvastatin-Associated Gynecomastia

Famularo¹,

Sarrecchia²

2021

Ann Pharmacother

View full text Add to dashboard Cite

“…In summary, to make the best use of available resources, detected SDRs require clinical review of the reports (Wisniewski et al, 2016). Examples of works that combine DA with a clinical review of reports may be found (de Jong et al, 2012;Tarapués et al, 2013;Viola et al, 2014;Béné et al, 2016;Valdiserra et al, 2023).…”

Section: Signals Signals Of Disproportionate Reporting and Risksmentioning

confidence: 99%

Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems

Cutroneo,

Sartori,

Tuccori

et al. 2024

Front. Drug Saf. Regul.

Self Cite

View full text Add to dashboard Cite

Spontaneous reporting systems remain pivotal for post-marketing surveillance and disproportionality analysis (DA) represents a recognized approach for early signal detection. Although DAs cannot be used per se as a standalone approach to assess a drug-related risk and cannot replace clinical judgment in the individual patient, their role remain irreplaceable for rapid detection of rare and unpredictable adverse drug reactions with strong drug-attributable component (e.g., designated medical events), especially when developed by a multidisciplinary team and combined with a careful case-by-case analysis (individual inspection of reports for causality assessment or to uncover reporting patterns and clinical features). In the recent past, a remarkable increase in publications of pharmacovigilance studies using DAs was observed, albeit the quality was debated: several publications contained “spin”, namely, misinterpretation of results to infer causality, calculate incidence, or provide risk stratification, which may ultimately result in unjustified alarm. The development of dedicated Guidelines by the international READUS-PV project (https://readus-statement.org/) will allow reproducible and transparent publication of accurate DAs, thus supporting their real transferability and exploitation by regulators and clinicians. This review offered a perspective on methodological aspects (and understanding) of DAs, their rationale, design, reporting, and interpretation.

show abstract

“…New member countries developed PV centers to report the ADRs and coordinate with the WHO center in Uppsala, where VigiBase is based. VigiBase contains more than 8 million ADR reports from more than 110 countries 62 . VigiFlow is an internet-based system that offers free access to all member countries to see all information and reports in VigiBase, and their analysis from all over the world 63 .…”

Section: Policies and Procedures For Implementing Pharmacovigilancementioning

confidence: 99%

Pharmacovigilance in perspective: drug withdrawals, data mining and policy implications

2019

View full text Add to dashboard Cite

Considering that marketed drugs are not free from side effects, many countries have initiated pharmacovigilance programs. These initiatives have provided countries with methods of detection and prevention of adverse drug reactions at an earlier stage, thus preventing harm occurring in the larger population. In this review, examples of drug withdrawals due to effective pharmacovigilance programs have been provided with details. In addition, information concerning data mining in pharmacovigilance, an effective method to assess pharmacoepidemiologic data and detecting signals for rare and uncommon side effects, is also examined, which is a method synchronized with information technology and advanced electronic tools. The importance of policy framework in relation to pharmacovigilance is discussed in detail, and country experiences upon implementation of pharmacovigilance policies is highlighted.

show abstract

α1-Adrenergic receptor antagonists and gynecomastia. A case series from the Italian spontaneous reporting system and VigiBase™

Abstract: In this study, we highlight a possible association between gynecomastia and tamsulosin use. To our knowledge, this association has not been described before and could represent a potential signal.

Cited by 6 publications

References 13 publications

Atorvastatin-Associated Gynecomastia

Atorvastatin-Associated Gynecomastia

Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems

Pharmacovigilance in perspective: drug withdrawals, data mining and policy implications

Contact Info

Product

Resources

About