Ranitidine Medicines Suspended

Another drug, another suspension over Nitrosamine impurities.

The European Medicines Agency human medicines committee (CHMP) has followed the lead of the US FDA and recommended the suspension of all Ranitidine medicines in the EU due to the low level presence of N-nitrosodimethylamine (NDMA).

In a recently issued notification it was made clear that NDMA, which is classified as a probable human carcinogen, has been found beyond acceptable levels in several ranitidine medicines.

While many ranitidine medicines have not been available in the EU for several months while a review was ongoing, the drug itself, most commonly used for reducing levels of stomach acid in patients with conditions such as heartburn and stomach ulcers, has now been suspended until the time that more data is available.

While it is not clear whether NDMA can be formed from Ranitidine inside the body itself, evidence shows that NDMA may form, with increasing levels, from the degradation of Ranitidine over its shelf life, especially in warmer temperatures and that of course causes serious concern.

NDMA, which is present in some foods and water supplies and is not expected to cause harm when ingested at very low levels, however, NDMA has been found in several ranitidine medicines above levels considered acceptable, and in addition there are unresolved questions about the source of the impurities. It is therefore no longer optional, but rather it is critical to conduct a risk evaluation which can identify active substances and finished products at risk of N-nitrosamine formation or (cross-)contamination.  

Learn how Quinta can help with such testing using our isotopically labeled standard detection methods for APIs, solid dosage forms, solutions for infusion, oral solutions, semi-finished products and more.

Sources:

https://www.ema.europa.eu/en/news/suspension-ranitidine-medicines-eu

https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market

Posted on

May 13, 2020

Heading

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Posted on

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse varius enim in eros elementum tristique. Duis cursus, mi quis viverra ornare, eros dolor interdum nulla, ut commodo diam libero vitae erat. Aenean faucibus nibh et justo cursus id rutrum lorem imperdiet. Nunc ut sem vitae risus tristique posuere.

in

Text Link

category

related
We're there now! Please visit us at stand 121B56.
We're there now! Please visit us at stand 121B56.
We're at CPhI Worldwide! Visit us at stand 121B56.
Let's Go!