Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Medication safety

EMA to begin review of ranitidine medicines after impurity found

The probable human carcinogen N-nitrosodimethylamine has been found in the heartburn and stomach ulcer medicine ranitidine.

guido-rasi-executive-director-european-medicines-agency-14

Source: European Mediciens Agency

Guido Rasi, executive director at the European Medicines Agency, said: “It is of paramount importance that we learn from our experience with sartans and take a proactive approach for other classes of medicines”

The European Medicines Agency (EMA) is to start a review of ranitidine medicines after tests revealed that some products contain the impurity N-nitrosodimethylamine (NDMA).

NDMA is classified as a probable human carcinogen, but is not thought to cause harm when ingested at very low levels.

In 2018, NDMA and similar compounds known as nitrosamines were found in several blood pressure medicines known as ‘sartans’, leading to recalls and an EU review which set strict new manufacturing requirements for these medicines. According to the EMA, the impurity has also been detected in a few batches of the type 2 diabetes mellitus medicines, pioglitazone.

Ranitidine medicines, which belong to a class of medicines known as histamine-2 blockers, are used widely to reduce the production of stomach acid in patients with conditions such as heartburn and stomach ulcers. They are available over-the-counter and on prescription.

The EMA will be evaluating whether patients using ranitidine are at any risk and will provide information as soon as it is available.

The agency has also asked the Committee for Medicinal Products for Human Use to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances. The guidance will be directed at marketing authorisation holders, who will be expected to consider it alongside their knowledge of the manufacturing processes of their products.

The committee will also evaluate all available scientific knowledge on the presence of nitrosamines in medicines and advise regulatory authorities on actions to take if companies find nitrosamines in their medicines.

“We will continue to work with our partners to address the presence of nitrosamines and reassure patients about the quality of their medicines,” said Guido Rasi, executive director at the EMA.

“It is of paramount importance that we learn from our experience with sartans and take a proactive approach for other classes of medicines.”

A spokesperson for the Medicines and Healthcare products Regulatory Agency said it was aware of the EMA review, but not of any specific information that would indicate that there was any risk to patients and was not currently initiating any product recalls.

“We are monitoring the issue, [will] continue to liaise with our European counterparts and will take appropriate action if necessary,” they said.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20207071

Readers' comments (1)

  • I don't know what happened with sartans after the dust settled. It'll be interesting to know what happens here, especially as Ranitidine was one of the much-trumpeted POM to P items, unlike sartans.

    Unsuitable or offensive? Report this comment

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 1 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £138.50Buy now
  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 2 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £262.50Buy now
  • Pharmaceutical Statistics

    Pharmaceutical Statistics

    This book on basic statistics has been specifically written for pharmacy students.

    £33.00Buy now
  • Pharmaceutical Toxicology

    Pharmaceutical Toxicology

    Explains the methodology and requirements of pre-clinical safety assessments of new medicines. Includes registration requirements and pharmacovigilance.

    £40.00Buy now
  • Strategic Medicines Management

    Strategic Medicines Management

    A practical guide to influencing the availability of medicines, and policies of their use. Focuses on the strategic elements of medicines management.

    £33.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Jobs you might like

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.