title: Safety profile of antiviral medications: a pharmacovigilance study using the Italian spontaneous-reporting database.
abstract: OBJECTIVE
  The results of an analysis of suspected antiviral-associated adverse drug reactions (ADRs) in Italy over a 22-year period are presented.
  
  
  METHODS
  A case/non-case analysis was conducted using ADR reports compiled in the nationwide spontaneous-reporting database through September 2010. All reported events included in the analysis were evaluated and coded by drug safety experts; causality assessments were performed according to the algorithm of Naranjo et al. The association between an adverse reaction and antiviral use was assessed by estimating the reporting odds ratio (ROR), with 95% confidence interval (CI), as a measure of disproportionality.
  
  
  RESULTS
  Overall, 863 reports of suspected ADRs involving antivirals and 42,430 reports of adverse reactions to other drugs were identified; of those events, 3.3% and 64.3% were determined to be definite or probable ADRs, respectively, and an additional 32.4% were deemed possibly drug related. Several ADRs were disproportionately associated with antivirals relative to other drugs: renal colic (ROR, 25.5; 95% CI, 13.3-49.0), lactic acidosis (ROR, 18.6; 95% CI, 9.2-37.7), depression (ROR, 18.0; 95% CI, 11.6-27.9), anemia (ROR, 15.9; 95% CI, 12.3-20.4), hallucination (ROR, 4.3; 95% CI, 2.7-7.1), neutropenia (ROR, 4.1; 95% CI, 2.9-5.8), acute renal failure (ROR, 3.9; 95% CI, 2.3-6.4), fever (ROR, 3.8; 95% CI, 2.8-5.1), hyperpyrexia (ROR, 2.9; 95% CI, 1.7-4.9), and asthenia (ROR, 1.8; 95% CI, 1.2-2.8).
  
  
  CONCLUSIONS
  Analysis of data from a large Italian database showed that, among antiviral agents, the ribavirin-interferon combination, acyclovir, valacyclovir, indinavir, and zidovudine accounted for the most serious hematologic, neuropsychiatric, and renal ADRs.
authors.affiliation: Department of Neuroscience, Psychology, Drug Research and Child Health, Interuniversity Center of Molecular Medicine and Applied Biophysics (CIMMBA), University of Florence, Florence, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Pugi
authors.forename: Roberto
authors.initials: R
authors.lastname: Bonaiuti
authors.forename: Valentina
authors.initials: V
authors.lastname: Maggini
authors.forename: Martina
authors.initials: M
authors.lastname: Moschini
authors.forename: Marco
authors.initials: M
authors.lastname: Tuccori
authors.forename: Roberto
authors.initials: R
authors.lastname: Leone
authors.forename: Marco
authors.initials: M
authors.lastname: Rossi
authors.forename: Domenico
authors.initials: D
authors.lastname: Motola
authors.forename: Carlo
authors.initials: C
authors.lastname: Piccinni
authors.forename: Fernanda
authors.initials: F
authors.lastname: Ferrazin
authors.forename: Laura
authors.initials: L
authors.lastname: Sottosanti
authors.forename: Alessandro
authors.initials: A
authors.lastname: Mugelli
authors.forename: Alfredo
authors.initials: A
authors.lastname: Vannacci
authors.forename: Francesco
authors.initials: F
authors.lastname: Lapi
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007558:Italy; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D000998:Antiviral Agents