title: Possible occurrence of paraesthesia in patients taking norethisterone: an analysis on the WHO Global Individual Case Reports database (VigiBase).
abstract: OBJECTIVE
  Progestogens are widely used to treat a large number of common conditions. We aimed to investigate a potential signal concerning progestogens and paraesthesia.
  
  
  METHODS
  Data were obtained from the VigiBase, the WHO Global Individual Case Safety Reports (ICSR) database, which is maintained by the Uppsala Monitoring Centre. We collected all suspected reports of paraesthesia associated with oral progestogens, reported between January 1972 and June 2012 and classified in VigiBase according to WHO-Adverse Reaction Terminology critical term 'paraesthesia'. A disproportionality analysis was conducted using the Information Component (IC) and the standard deviation (IC025) as a measure.
  
  
  RESULTS
  Out of the total number of reports collected in the VigiBase (7,332,991), paraesthesia was associated with progestogen therapy in 920 reports, coming from 22 countries. Progestogens had the highest number of suspected reports (n = 864) than the other Anatomical Therapeutic Chemical (ATC) considered. Only norethisterone was associated with paraesthesia with positive IC (0.47) and IC025 (0.02).
  
  
  CONCLUSIONS
  Norethisterone-associated paraesthesia appears to be a rare outcome. However, the widespread use of progestogens in medical practice suggests that it is a complaint that can affect a large number of women. Since paraesthesia can be caused by several drugs, clinicians should consider that it may be also caused by norethisterone.
authors.affiliation: University of Bologna, Department of Medical and Surgical Sciences, Unit of Pharmacology, Bologna, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Buccellato
authors.forename: Chiara
authors.initials: C
authors.lastname: Biagi
authors.forename: Alberto
authors.initials: A
authors.lastname: Vaccheri
authors.forename: Mauro
authors.initials: M
authors.lastname: Melis
authors.forename: Nicola
authors.initials: N
authors.lastname: Montanaro
authors.forename: Domenico
authors.initials: D
authors.lastname: Motola
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D016208:Databases, Factual; D005260:Female; D006801:Humans; D008297:Male; D009640:Norethindrone / Q000009:adverse effects*; D010292:Paresthesia / Q000139:chemically induced*; D014944:World Health Organization
chemical_list: D009640:Norethindrone