title: Emergency contraceptive pill safety profile. Comparison of the results of a follow-up study to those coming from spontaneous reporting.
abstract: BACKGROUND
  The emergency contraceptive pill (ECP) containing levonorgestrel is dispensed without a prescription in Spain since 2009. An easy access could diminish unwanted pregnancies; however, there is a risk of misuse and, in any case, of developing some adverse events. The aim of the present study is to further learn the adverse effects of this ECP.
  
  
  METHODS
  An ad hoc follow-up study was carried out in three community pharmacies in a city of Central Spain; the sample was composed of those women asking for the ECP; they were interviewed by telephone after at least a month since the last menses. We completed the safety profile obtained with that coming from spontaneous reporting in Spain.
  
  
  RESULTS
  Out of 139 women surveyed, 113 developed any adverse event--two considered as severe; the most frequently reported events were menstrual disturbances, which accounted for 21% of all events. Through spontaneous reporting, 36 cases of whatever adverse events related to levonorgestrel as ECP were identified. Twenty-five cases were considered as severe. Both types of reaction and severity were significantly different in the follow-up study and in the spontaneous reporting. Some of the reactions identified, such as miscarriage, febrile neutropenia, and porphyria, are not included in the Summary of Product Characteristics.
  
  
  CONCLUSIONS
  Levonorgestrel as an ECP is mostly safe. Attention should be paid to some severe events and particularly to those risk factors for them to appear. Combining spontaneous reporting with an ad hoc follow-up study, the whole safety profile of a given medication can be obtained.
authors.affiliation: Centro de Estudios sobre la Seguridad de los Medicamentos (CESME), Universidad de Valladolid, Valladolid, Spain.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Carvajal
authors.forename: María
authors.initials: M
authors.lastname: Sáinz
authors.forename: Verónica
authors.initials: V
authors.lastname: Velasco
authors.forename: Pilar
authors.initials: P
authors.lastname: García Ortega
authors.forename: Carlos
authors.initials: C
authors.lastname: Treceño
authors.forename: Luis H
authors.initials: LH
authors.lastname: Martín Arias
authors.forename: María
authors.initials: M
authors.lastname: Pellón
authors.forename: Luis
authors.initials: L
authors.lastname: García Sevillano
mesh_terms: D000293:Adolescent; D000328:Adult; D003281:Contraceptives, Postcoital / Q000008:administration & dosage / Q000009:adverse effects*; D003625:Data Collection / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D008599:Menstruation Disturbances / Q000139:chemically induced / Q000453:epidemiology; D008875:Middle Aged; D057566:Self Report / Q000592:standards*; D055815:Young Adult
chemical_list: D003281:Contraceptives, Postcoital
keywords: ADR spontaneous reporting; adverse events; emergency contraceptive pill (ECP); follow-up study; pharmacoepidemiology