At the request of the European Commission, the European Medicines EMA triggered a review of ranitidine medicines after tests showed that some of these products contained an impurity called Nnitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen (a substance that could cause cancer) on the basis of animal studies.
Ranitidine
belongs to a class of medicines known as H2 (histamine-2) blockers, which work
by blocking histamine receptors in the stomach and reducing the production of
stomach acid. It is used to treat and prevent conditions caused by excess acid
in the stomach such as heartburn and stomach ulcers. Ranitidine-containing
medicines are authorised by national authorities and are available as tablets
and injectable formulations (EMA, 2019).
In
2018, NDMA and similar compounds known as nitrosamines were found in a number
of blood pressure medicines known as ‘sartans’, leading to some recalls and to
an EU review, which set strict new manufacturing requirements for these
medicines. In 2019, a nitrosamine impurity has been detected in a few batches
of pioglitazone from one company and in batches of ranitidine.
The
chemical is present in some foods and in water supplies but is not expected to
cause harm when ingested in very low levels.
The
review of ranitidine medicines was initiated on 12 September 2019 at the
request of the European Commission, under Article 31 of Directive 2001/83/EC. The
review will be carried out by the Committee for Medicinal Products for Human
Use (CHMP), responsible for questions concerning medicines for human use, which
will adopt an opinion. The CHMP opinion will then be forwarded to the European
Commission, which will issue a final legally binding decision applicable in all
EU Member States. The EMA evaluated the data to assess whether patients using
ranitidine are at any risk from NDMA and undertook to provide information about
this (at the time of writing, no further information was made available) (EMA,
2019b).
In
2019, the FDA announced that a voluntary recall of 14 lots of prescription
ranitidine capsules distributed by Sandoz Inc., used to decrease the amount of
acid created by the stomach, had taken place in relation to N-nitrosodimethylamine
(FDA, 2019b).
EMA
(2019a) EMA to provide guidance on avoiding nitrosamines in human medicines,
European Medicines Agency, at: https://www.ema.europa.eu/en/documents/press-release/ema-provide-guidance-avoiding-nitrosamines-human-medicines_en.pdf (accessed 6th November 2019)
EMA
(2019b) EMA to review ranitidine medicines following detection of NDMA.
European Medicines Agency, at: https://www.ema.europa.eu/en/documents/referral/ranitidine-article-31-referral-ema-review-ranitidine-medicines-following-detection-ndma_en.pdf (accessed 6th
November 2019)
FDA
(2019a) Statement alerting patients and health care professionals of NDMA found
in samples of ranitidine, US Food and Drug Administration at: https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine (accessed 6th
November 2019)
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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