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Postmarketing Safety Evaluation of Aliskiren Hemifumarate, a New Molecular Entity.
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 Material Information
Title: Postmarketing Safety Evaluation of Aliskiren Hemifumarate, a New Molecular Entity.
Physical Description: Conference Papers
Creator: Ayad K Ali
Conference: 2010 PSWC and AAPS Annual Meeting and Exposition.
Publisher: Springer and the American Association of Pharmaceutical Scientists.
Place of Publication: USA
Publication Date: November 25, 2010
 Notes
Abstract: Purpose. To evaluate the safety profile of aliskiren by calculating the adjusted reporting ratios of specific adverse events. Methods. The Food and Drug Administration’s (FDA) Adverse Event Reporting System (AERS) data are utilized to conduct this retrospective pharmacovigilance study. Adverse event (AE) reports submitted to the AERS during the period of January 2007 through December 2008 are included in the analysis. Systematic Multi-item Gamma Poisson Shrinker (MGPS) data mining algorithm is applied to calculate the adjusted reporting ratios (ARR) of AE, which are estimated by the Empiric Bayes Geometric Mean (EBGM) values and their 95% confidence intervals (95%CI). EBGM values of >2.0 are considered as safety signals significant for regulatory decisions. Reports for aliskiren and other drugs affecting the Renin-Angiotensin-Aldosterone System (RAAS) are identified using the verbatim names for each individual class member. Reports for specific AE are identified by the utilized Preferred Terms of the Medical Dictionary for Regulatory Activities coding scheme (MedDRA PT) in the AERS. Results. During the study period, a total number of 2,154 reports for aliskiren are received by the AERS. Seventy four percent (1,592) of these reports had valid MedDRA terms, and included in the analysis. Compared to other RAAS modulators, aliskiren was associated with the highest ARR for angioedema (EBGM 3.9, 95%CI 3.2-4.7), renal dysfunction (EBGM 3.4, 95%CI 2.6-4.5), dry cough (EBGM 11.0, 95%CI 7.8-14.2), and diarrhoea (EBGM 4.3, 95%CI 3.2-5.8). Aliskiren ranked the second after aldosterone antagonists in hyperkalaemia (EBGM 7.4, 95%CI 3.4-13.0). Conclusion. Treatment with aliskiren may be associated with angioedema and renal dysfunction. Patients with signs and symptoms of angioedema should stop aliskiren and seek urgent medical help. Aliskiren should not be used by patients with risks of renal dysfunction. While additional longitudinal studies and clinical awareness is warranted, regulatory changes in product label and safety communications, e.g. dear-healthcare-professional letters are recommended meanwhile actions.
Acquisition: Collected for University of Florida's Institutional Repository by the UFIR Self-Submittal tool. Submitted by Ayad K Ali.
Publication Status: Published
General Note: Citation: The AAPS Journal. November 2010;12(S2):W4001.
 Record Information
Source Institution: University of Florida Institutional Repository
Holding Location: University of Florida
Rights Management: All rights reserved by the source institution.
System ID: IR00000604:00001

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Postmarketing Safety Evaluation of Aliskiren Hemifumarate, a New Molecular Entity. A. Ali 1 1 University of Florida Purpose. To evaluate the safety profile of aliskiren by calculating the adjusted reporting ratios of specific adverse events. Methods. The Food and Drug Administration’s (FDA) Adverse Event Reporting System (AERS) data are ut ilized to conduct this retrospective pharmacovigilance study. Adverse event (AE) reports submitted to the AERS during the period of January 2007 through December 2008 are included in the analysis. Systematic Multi-item Gamma Poisson Shrinker (MGPS) data mining algorithm is applied to calculate the adjusted reporting ratios (ARR) of AE, which are estimated by the Empiric Bayes Geometric Mean (EBGM) values and their 95% confidence intervals (95%CI). EBGM values of >2.0 are considered as safety signals significant for regulatory decisions. Reports for aliskiren and other drugs affecting the Renin-AngiotensinAldosterone System (RAAS) are identified using the verbatim names for each individual class member. Reports for specific AE are identified by the utilized Preferred Terms of the Medical Dictionary for Regulatory Activities coding scheme (MedDRA PT) in the AERS. Results. During the study period, a total number of 2,154 reports for aliskiren are received by the AERS. Seventy four percent (1,592) of these reports had valid MedDRA terms, and included in the analysis. Compared to other RAAS modulators, aliskiren was associated with the highest ARR for angioedema (EBGM 3.9, 95%CI 3.2-4.7), renal dysfunction (EBGM 3.4, 95%CI 2.64.5), dry cough (EBGM 11.0, 95%CI 7.8-14.2), and diarrhoea (EBGM 4.3, 95%CI 3.2-5.8). Aliskiren ranked the second after aldosterone antagonists in hyperkalaemia (EBGM 7.4, 95%CI 3.4-13.0). Conclusion. Treatment with aliskiren may be associated with angioedema and renal dysfunction. Patients with signs and symptoms of angioedema should stop aliskiren and seek urgent medical help. Aliskiren should not be used by patients with risks of renal dysfunction. While additional longitudinal studies and clinical awareness is warranted, regulatory changes in product label and safety communications, e.g. dear-healthcare-professional letters are recommended meanwhile actions.


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