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 at the EMA

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.

Last updated
The Pharmaceutical Journal, PJ, October 2019, Vol 303, No 7930;303(7930):DOI:10.1211/PJ.2019.20207071

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