Review of ranitidine-containing drugs due to possible contamination with NDMA.

Measures at EU level

At the request of the European Commission, the European Medicines Agency (EMA) has begun reviewing medicines containing ranitidine after investigations found contamination with N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen based on animal studies. It is also present in small amounts in some foods and water supplies, but NDMA is not expected to cause harm if ingested in very small amounts. EMA is currently evaluating data to assess the risk to patients treated with ranitidine-containing medicines who have come into contact with NDMA through ingestion. As soon as results are available, information will be published. Ranitidine-containing medicines are widely used medicines to reduce gastric acid production in reflux disease and ulcer therapies. These drugs are available in the European Union both by prescription and over the counter. In Austria, the currently approved drugs are only available by prescription. Patients who have concerns about therapy based on the available evidence may wish to consult the attending physician, pharmacist, or pharmacist. Other drugs or alternatives are approved for the same treatment areas as ranitidine. NDMA and related substances, which are generally referred to as nitrosamines, were found in some blood pressure medications (also known as angiotensin II receptor blockers or "sartans") in 2018. This led to recalls across Europe and subsequently to strict new requirements for the manufacture of medicines containing sartans. EMA is currently working on a guideline to avoid nitrosamines in other drug classes. EMA will continue to work with national medicines authorities, EDQM (European Directorate for the Quality of Medicines), and international partners to protect patient health and take effective action to ensure medicines are free of nitrosamine-containing impurities. Update 09/26/2019: Due to initial results on ranitidine-containing medicines tested positive for NDMA in Europe, the CEP (Certificate of Suitability of Monographs of the European Pharmacopoeia concerning the active substance) of "SARACA LABORATORIES LIMITED IN 502 319 Gaddapotharam Village" (hereinafter abbreviated as "Saraca"), R1-CEP 2004-057-Rev 07, was suspended by EDQM (European Directorate for the Quality of Medicines) as of 09/19/2019.

About medicines containing ranitidine

Ranitidine belongs to the class of medicines known as H2 blockers (histamine-2 blockers). They block histamine receptors in the stomach, thus reducing the production of stomach acid. Ranitidine is used to treat and prevent conditions caused by excess stomach acid such as heartburn and stomach ulcers. Medicines containing ranitidine are approved by national drug regulatory authorities and marketed as tablets or injection/infusion in the European Union.

About the procedure

The procedure for the review of medicinal products containing ranitidine was launched on September 12, 2019, at the request of the European Commission as an Article 31 procedure (Article 31 of Directive 2001/83/EC). The procedure is conducted and decided by the CHMP ("Committee for Medicinal Products for Human Use" or Committee for Medicinal Products for Human Use). This CHMP decision will be forwarded to the European Commission after evaluation and will finally become a legally binding requirement for all European member states.

Situation in Austria

Update Sept. 26, 2019:Since NDMA is classified as a probable human carcinogen and the CEP on Ranitidine hydrochloride of "Saraca" has been suspended, those medicinal products or batches manufactured with active ingredient of "Saraca" are recalled as a precautionary measure down to the pharmacy level. Corresponding investigations have been initiated in order to identify possible further affected ranitidine-containing medicinal specialties that are on the market in Austria. BASG will take further action and provide information according to these results and assessment of benefits and risks. In Austria, therefore, further medicinal specialties affected by possible NDMA contamination are being recalled as a precautionary measure down to the pharmacy level (as of Sept. 26, 2019):

1. Ranitidine Accord 150 mg film-coated tablets
2. Ranitidine Accord 300 mg film-coated tablets
3. Zantac 150 mg - Effervescent Tablets
4. Zantac 300 mg - Effervescent Tablets
5. Ranitidine "ratiopharm" 150 mg - film-coated tablets
6. Ranitidine "ratiopharm" 300 mg - film-coated tablets

The following drug products have already been recalled: 7 . ranitidine 1A Pharma 300 mg - film-coated table ts 8 . Ranic Hexal 150 mg - film-coated tablets 9 . Ranic Hexal 300 mg - film -coated tablets Information on the affected lot numbers or recalls can also be found in the BASG Official News.

The BASG has not received any adverse event reports from Austria for the above-mentioned drugs that are relevant to this issue.

Recommendations of the BASG

Recommendations for users:

Please evaluate the use of an alternative medicinal product.

Recommendations for patients:

There is no acute danger. From today's point of view, there is therefore no acute need to discontinue an opened package. If you have any further questions or feel unsure, please contact your doctor. Your doctor may prescribe another suitable medicine if necessary.

Further information

European Medicines Agency press release (Sept. 13, 2019): EMA to review ranitidine medicines following detection of NDMAEMA to provide guidance on avoiding nitrosamines in human medicines

Queries (technical):

Dr. Christoph Baumgärtel, Tel: 050555 - 36004 Email: christoph.baumgaertel@ages.at

Queries (for media):

Communications Management, Tel: 050555 - 25000 E-mail: presse-basg@basg.gv.at

Further inquiry note

basg_anfragen@basg.gv.at