Leuprorelin and medication error and lack of effect - An analysis of EudraVigilance

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Case series review of Pharmacovigilance data
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Descriptive study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LEUPRORELIN
• Medical condition to be studied:
  Medication error
• Additional medical condition(s):
  Consequences of medication errors with leuprorelin

Population studied

• Short description of the study population:
  The study focused on medication errors and lack of efficacy reports of leuprorelin-containing medicinal products identified from EudraVigilance database.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1707

Study design details

• Main study objective:
  The objective was to describe the characteristics of reports of medication errors and lack of effect to leuprorelin and potential consequences.
• Data analysis plan:
  Descriptive statistics were performed to characterise the reports. These included an overview of case reports by population and drug characteristics, time-trend of case reports and distribution of reported reactions. Disproportionality statistics were calculated for at High level term (HLT) level. To perform the calculation at HLT level, all HLTs under the SMQs and SOCs as well as the HLT Reproductive hormone analyses were used.

Documents

Study results

Leuprorelin and ME and LE - EV report - 20190731