Depression following exposure to anastrozole

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39771
• EU PAS number:
  EUPAS39770
• Study ID:
  39771
• Official title and acronym:
  Depression following exposure to anastrozole
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Anastrozole is drug that is widely used for the treatment of certain types of breast cancer in older women. Recently, its use has been reported as being associated with the onset of depressive illness. This issue is being evaluated by the European Union’s Pharmacovigilance Risk Assessment Committee (PRAC), which is a regulatory body responsible for assessing and monitoring the safety of human medicines. This study simply describes how often depressive illness occurs after patients are prescribed anastrozole and shows how this varies with time. To allow contextualisation of the results, the same analysis has also been done in two other groups of patients. The first group are patients prescribed a similar medicine also used in the treatment of breast cancer (tamoxifen). The second group are patients who have had breast cancer and are then prescribed a medicine which is not used for the treatment of breast cancer and which is not known to cause depression (bendroflumethiazide). The results of this study will be used by the PRAC in its decision-making process by helping to decide if regulatory action needs to be taken to protect patients taking anastrozole in the future.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 01/09/2020

Actual: 01/09/2020

Study start date

Planned: 01/09/2020

Actual: 01/09/2020

Date of final study report

Planned: 08/12/2020

Actual: 08/12/2020

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable