Study identification

PURI

https://redirect.ema.europa.eu/resource/44568

EU PAS number

EUPAS44548

Study ID

44568

Official title and acronym

Study of exposure and use patterns of alternatives to ranitidine-containing medicines in patients treated with ranitidine (Ranitidine)

DARWIN EU® study

No

Study countries

Belgium
France
Germany
Netherlands
Spain
United Kingdom

Study description

Ranitidine is a competitive and reversible inhibitor of the action of histamine and indicated for the management of peptic ulceration (with or without Helicobacter Pylori), Gastro-Esophageal Reflux Disease (GERD), reflux oesophagitis and Zollinger-Ellison syndrome. In 2019, results of a preliminary laboratory analysis have shown the presence of N-Nitrosodimethylamine (NDMA), a human carcinogen, in ranitidine. Many ranitidine-containing medicines have not been available in the EU for several months since the initiation of the referral, because national competent authorities have recalled them either due to levels of NDMA found in the products or as a precaution while the EMA review is ongoing. Healthcare professionals have been asked to advise patients on alternative medicines. In addition, in some Member States the outcome of the referral was communicated at national level through media campaigns, involving learned societies and medical associations to inform prescribing physicians and health care organisations about these changes. The unavailability of ranitidine-containing medicines is expected to cause patients to switch treatment to alternative medicines or alternative treatment strategies. The extent of switches to alternative medicines remains unknown as well as the rate of patients permanently discontinuing treatment following unavailability of ranitidine-containing medicines. The overall aim of this study is to evaluate the impact of the regulatory actions taken for ranitidine containing medicinal products following the 2019 referral procedure, using healthcare databases of six European countries. Data from these databases have been mapped to the OMOP Common Data Model.

Study status

Finalised
Research institution and networks

Institutions

Multiple centres: 6 centres are involved in the study, Erasmus University Rotterdam

Contact details

Katia Verhamme

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

ranitidine protocol_16thseptember2021_clean

English (2.14 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable