A Post-Marketing Surveillance of the Abuse of Eluxadoline using Poison Centre Data in the United States and Canada

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Observational surveillance
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational surveillance

Study drug and medical condition

• Name of medicine, other:
  Eluxadoline

Population studied

• Short description of the study population:
  All cases of human exposure to eluxadoline recorded in the National Poison Data System from January 2017 to December 2019 and in the Canadian Poison Centre Network Program from January 2018 to December 2019 will be identified and included in the analyses.; Exposures confirmed to be non-exposures and non-human exposures will be excluded.
• 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:
  10000

Study design details

• Main study objective:
  To quantify the rate of abuse and serious adverse events for eluxadoline during a 3-year post approval period
• Outcomes:
  Rate of abuse and serious adverse events
• Data analysis plan:
  • All cases of exposure to eluxadoline recorded in the National Poison Data System from January 2017 to December 2019 and in the Canadian Poison Centre Network Program from January 2018 to December 2019 will be identified and included in the analyses • Cases of eluxadoline exposure will be presented descriptively by patient demographics, reason and medical outcome, by quarter. Population-adjusted rates and 95% confidence intervals will be calculated using census data in order to adjust for exposure in the covered population quarterly and cumulatively

Documents

Study results

RADARS System Allergan EUPAS 25247 2019_Abstract

Study, other information

RADARS System Annual Study Report Allergan 2018_Abstract

Truberzi Canada_RADARS System (1st Interim Report Abstract)