NDLI: Safety profile of the fluoroquinolones: analysis of adverse drug reactions in relation to prescription data using four regional pharmacovigilance databases in Italy.

Please wait, while we are loading the content...

Identifying major congenital malformations in the UK General Practice Research Database (GPRD): a study reporting on the sensitivity and added value of photocopied medical records and free text in the GPRD.

Paediatric postmarketing pharmacovigilance using prescription-event monitoring: comparison of the adverse event profiles of lamotrigine prescribed to children and adults in England.

Completeness of published case reports on suspected adverse drug reactions: evaluation of 100 reports from a company safety database.

Adverse drug reaction reporting in the UK: a retrospective observational comparison of yellow card reports submitted by patients and healthcare professionals.

Safety profile of the fluoroquinolones: analysis of adverse drug reactions in relation to prescription data using four regional pharmacovigilance databases in Italy.

Year: 2010 Volume: 33 Issue: 8

Year: 2010 Volume: 33 Issue: 7

Year: 2010 Volume: 33 Issue: 6

Year: 2010 Volume: 33 Issue: 5

Year: 2010 Volume: 33 Issue: 4

Year: 2010 Volume: 33 Issue: 3

Year: 2010 Volume: 33 Issue: 2

Year: 2010 Volume: 33 Issue: 1

Year: 2009 Volume: 32

Year: 2008 Volume: 31

Safety profile of the fluoroquinolones: analysis of adverse drug reactions in relation to prescription data using four regional pharmacovigilance databases in Italy.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Lapi, Francesco Tuccori, Marco Motola, Domenico Pugi, Alessandra Vietri, Michele Montanaro, Nicola Vaccheri, Alberto Leoni, Olivia Cocci, Alfredo Leone, Roberto Conforti, Anita Moretti, Ugo Sessa, Emiliano Mazzaglia, Giampiero Mugelli, Alessandro Mazzei, Teresita Vannacci, Alfredo
Spatial Coverage	Italy
Description	Country affiliation: Italy Author Affiliation: Lapi F ( Department of Pharmacology, University of Florence, Tuscan Regional Centre of Pharmacovigilance, Florence, Italy. francesco.lapi@unifi.it)
Abstract	BACKGROUND: Fluoroquinolones are widely used both in primary care and in hospital settings. Since the last comparison performed in Italy on the safety profiles of different fluoroquinolones, a new molecule, prulifloxacin, has been introduced into the market and several warnings concerning this class of drugs have been released. The aim of this study was to reassess the safety profiles of fluoroquinolones using the database of the Italian Interregional Group of Pharmacovigilance (IGP) and the administrative data of fluoroquinolone prescriptions. METHODS: All adverse drug reactions (ADRs) reported in four Italian regions (Lombardy, Veneto, Emilia Romagna and Tuscany) were retrieved from the IGP database. Consumption data (defined daily dose [DDD]/1000 inhabitants/day) were used as denominators. Both single reports and all ADRs (classified by System Organ Classes and MedDRA Preferred Term [PT]) due to fluoroquinolones were considered as numerators of each analysis, comparing two periods (2005 vs 2006). All fluoroquinolones with at least ten reports per year were included in the analysis. RESULTS: On the basis of 272 reports (532 single ADRs or PTs), patients did not show any statistically significant differences between 2005 and 2006 in terms of sex, age and number of concurrent medications. After adjustment for drug consumption, moxifloxacin showed the highest reporting rate (84.6 reports/DDD/1000 inhabitants/day; 15.4 serious reports/DDD/1000 inhabitants/day) followed by prulifloxacin (72.2; 22.2 serious) and levofloxacin (55.3; 30.6 serious) in 2005. An increment of ADR/report rates was observed over the 2 years for all fluoroquinolones except prulifloxacin, which had the lowest ADR reporting rate in 2006 (25.0; 12.5 serious). In 2006, the rate of serious ADRs associated with prulifloxacin was lower than with ciprofloxacin, while in 2005 serious events were almost equal for both compounds (55.6 vs 47.6 serious ADRs/DDD/1000 inhabitants/day). Ciprofloxacin showed the highest proportion of cutaneous PTs (e.g. rash, exanthema). Tendinopathies were mainly due to levofloxacin. CONCLUSIONS: These data suggest that different fluoroquinolones are characterized by different rates and types of ADRs. Among them, prulifloxacin was associated with more ADRs than other fluoroquinolones in 2005 but with fewer ADRs in 2006, when its consumption increased. Although these findings may represent an encouraging perspective towards a more appropriate use of fluoroquinolones because of their individual safety profiles, further pharmacoepidemiological studies must be performed to substantiate these results.
File Format	HTM / HTML
ISSN	01145916
Issue Number	9
Volume Number	33
e-ISSN	11791942
Journal	Drug Safety
Language	English
Publisher	Springer
Publisher Date	2010-09-01
Publisher Place	New Zealand (Aotearoa)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Toxicology Adverse Drug Reaction Reporting Systems Statistics & Numerical Data Anti-infective Agents Adverse Effects Databases, Factual Fluoroquinolones Adolescent Adult Aged Aged, 80 And Over Administration & Dosage Child Female Humans Italy Male Middle Aged Young Adult Comparative Study Journal Article
Content Type	Text
Resource Type	Article
Subject	Toxicology Pharmacology Pharmacology (medical)

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Effect of pharmacist involvement on patient reporting of adverse drug reactions: first Italian study.

Drug Fever: a descriptive cohort study from the French national pharmacovigilance database.

Global patterns of adverse drug reactions over a decade: analyses of spontaneous reports to VigiBase™.

Safety profile of antiviral medications: a pharmacovigilance study using the Italian spontaneous-reporting database.

Adverse drug reactions to self-medication: a study in a pharmacovigilance database.

Ten years of pharmacovigilance in Italy: the experience of Emilia-Romagna region in the monitoring of drug's safety profile.

Identifying adverse drug reactions associated with drug-drug interactions: data mining of a spontaneous reporting database in Italy.

Incretin-mimetics associated pancreatitis: evidence from the spontaneous adverse drug reactions reporting in Italy.

Adverse drug reactions to local anaesthetics: a review of the French pharmacovigilance database.

Safety profile of the fluoroquinolones: analysis of adverse drug reactions in relation to prescription data using four regional pharmacovigilance databases in Italy.

Similar Documents

Effect of pharmacist involvement on patient reporting of adverse drug reactions: first Italian study.

Drug Fever: a descriptive cohort study from the French national pharmacovigilance database.

Global patterns of adverse drug reactions over a decade: analyses of spontaneous reports to VigiBase™.

Safety profile of antiviral medications: a pharmacovigilance study using the Italian spontaneous-reporting database.

Adverse drug reactions to self-medication: a study in a pharmacovigilance database.

Ten years of pharmacovigilance in Italy: the experience of Emilia-Romagna region in the monitoring of drug's safety profile.

Identifying adverse drug reactions associated with drug-drug interactions: data mining of a spontaneous reporting database in Italy.

Incretin-mimetics associated pancreatitis: evidence from the spontaneous adverse drug reactions reporting in Italy.

Adverse drug reactions to local anaesthetics: a review of the French pharmacovigilance database.

Safety profile of the fluoroquinolones: analysis of adverse drug reactions in relation to prescription data using four regional pharmacovigilance databases in Italy.