Severe hypersensitivity reactions associated with i.v. iron containing medicinal products in countries of the European Economic Area – before and after implementation of risk minimisation measures

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-population study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  This is a pharmacoepidemiologic study with case-population design using established data sources.

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B03AC) Iron, parenteral preparations

  Iron, parenteral preparations
• Medical condition to be studied:
  Anaphylactoid shock

  Anaphylactic reaction

Population studied

• Short description of the study population:
  All available records of anaphylactic reactions and anaphylactoid reactions associated with ferric carboxymaltose, iron sucrose, iron (III) isomaltoside 1000, iron dextran, iron gluconate/ferric gluconate or ferumoxytol in EEA countries in the time period 1 January 2010 to 31 December 2017 in EudraVigilance were considered for the analysis.
• Age groups:
  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:
  99999999

Study design details

• Main study objective:
  To evaluate the overall and substance-specific reporting rate of anaphylactic/anaphylactoid reactions associated with i.v. iron-containing substances with respect to overall exposure of each i.v. iron substance in EEA countries for the 4-year period preceding the implementation of risk minimization measures (2010-2013) and the 4-year period after the implementation (2014-2017)
• Data analysis plan:
  In a descriptive analysis reporting rates of severe hypersensitivity reactions defined as anaphylactic reaction, anaphylactic shock, anaphylactoid reaction and anaphylactoid shock will be determined by number of reports divided by the number of 100 mg dose equivalents (DEq, =DDD) of iron sold.