European Medicines Agency (EMA) announces that its human medicines committee (CHMP) has recommended the suspension of all ranitidine medicines in the EU due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on animal studies. It is present in some foods and water supplies and is not expected to cause harm when ingested at very low levels.
Available safety data do not show that ranitidine increases the risk of cancer, and any possible risk is likely to be very low. However, NDMA has been found in several ranitidine medicines above levels considered acceptable, and there are unresolved questions about the source of the impurities. There is some evidence that NDMA may form from the degradation of ranitidine itself with increasing levels seen over its shelf life. It is not clear whether NDMA can also be formed from ranitidine inside the body. Some studies suggest that it can while others do not. Given the uncertainties, the CHMP has recommended a precautionary suspension of these medicines in the EU.
Ranitidine medicines are used for reducing levels of stomach acid in patients with conditions such as heartburn and stomach ulcers. Alternatives are available and patients should contact their healthcare professionals if they need advice about which medicine to take. Many ranitidine medicines have not been available in the EU for several months. This is because national authorities have recalled them as a precaution while the EMA review was ongoing. EMA has also recommended conditions for lifting the suspension of ranitidine medicines, including requirements for companies to provide more data.
Since 2018 NDMA and similar compounds known as nitrosamines have been detected in a number of medicines, with EU regulators taking action to identify possible sources of the impurities and set strict new requirements for manufacturers. EMA will continue working with national authorities, the European Directorate for the Quality of Medicines and Healthcare (EDQM), the European Commission and international partners to make sure that effective measures are taken to prevent the presence of these impurities in medicines.
Information for patients:
- Ranitidine medicines are being suspended in EU as a precaution because of the presence at low levels of an impurity called NDMA.
- Alternative medicines are available. Contact their doctor or pharmacist if they have any questions about which alternative to take.
- If they have been prescribed ranitidine, their doctor will advise them on an alternative.
Information for healthcare professionals:
- Ranitidine medicines are being suspended in the EU due to the presence of NDMA impurities.
- Although the exact source of the impurity in ranitidine is yet to be determined, it is possible that NDMA may form from the degradation of ranitidine even under normal storage conditions. Some studies indicated that ranitidine may cause additional endogenous NDMA formation by its degradation or metabolism in the gastro-intestinal tract, although other studies did not.
- Available clinical and epidemiological data do not show that ranitidine increases the risk of cancer.
- While ranitidine medicines are unavailable, advise patients on alternative medicines.
- Healthcare professionals should advise patients who need assistance, including those who have been taking ranitidine without a prescription, on how to treat or manage conditions such as heartburn and gastric ulcers.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/suspension-ranitidine-medicines-eu
Currently, there are 64 registered pharmaceutical products containing ranitidine in Hong Kong. These products in the forms of oral preparations and injections are controlled as over-the-counter medicines and prescription-only medicines respectively. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to ranitidine.
Related news on the detection of NDMA in ranitidine products was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 16 Sep 2019, with the latest update posted on 3 Apr 2020. Letters to inform local healthcare professionals were issued by the DH on 18 Sep 2019 and 2 Apr 2020. The DH has contacted the relevant overseas drug regulatory authorities for further information regarding the detection of NDMA in ranitidine products, and continues to remain vigilant on the update findings and investigation result announced by the authorities.
The DH has contacted the certificate holders of all registered ranitidine products for follow up on the local impact of the issue; and to provide evidence that NDMA in the products are below the acceptable limit, and samples of ranitidine-containing products have been collected from the market for analysis. When any health risks are posed to the public, a press statement will be issued as soon as possible. The following are the main content of the press statements issued previously:
- On 24 Sep 2019, the DH endorsed a licensed drug wholesaler, GlaxoSmithKline Ltd, to recall all Zantac products (HK-42792, HK-42793, HK-30459, HK-42045) from the Hong Kong market as a precautionary measure due to the presence of NDMA in the products.
- On 25 Sep 2019, the DH endorsed licensed drug wholesalers Hind Wing Co Ltd and Top Harvest Pharmaceuticals Co Ltd to recall Apo-Ranitidine Tablets (HK-42273, HK-41873) and Zantidon Tablets 150mg (HK-64329) respectively.
- On 27 Sep 2019, the DH endorsed licensed drug manufacturer APT Pharma Limited and licensed drug wholesaler Eugenpharm International Limited to recall Amratidine Tablets 150mg (HK-53143) and Peptil H 150 Tablets 150mg (HK-65103) respectively.
- On 30 Sep 2019, the DH endorsed licensed drug wholesaler Vast Resources Pharmaceutical Limited to recall Weidos Tablets 150mg (HK-62210).
- On 11 Oct 2019, the DH endorsed licensed drug wholesaler Hind Wing Co Ltd to recall Epadoren Solution for Injection 50mg/2ml (HK-61752).
- On 1 Nov 2019, the DH endorsed licensed drug wholesaler Welldone Pharmaceuticals Limited to recall 6 ranitidine-containing products: Epirant Tab 150mg (HK-56826), Welldone Ranitidine Tab 150mg (HK-57473), Kin Pak Tab 150mg (HK-56824), Wah Tat Tab 150mg (HK-56823), Super Pro Tab 150mg (HK-56825) and Glo-Tac Tab 150mg (HK-57472).
- On 7 Nov 2019, the DH endorsed licensed drug wholesalers Healthcare Pharmascience Limited, Julius Chen & Co (HK) Limited and Atlantic Pharmaceutical Limited to recall 5 ranitidine-containing products: Raniplex 150 Tablet 150mg (HK-43456), Tupast Tablet 150mg (HK-50378), Wontac Tablet 150mg (HK-60085), Jecefarma Ranitidine Tablet 150mg (HK-64041) and Ratic Tablet 150mg (HK-61083).
- On 12 Nov 2019, the DH endorsed registration certificate holder Medreich Far East Limited to recall Ulticer Tab 150mg (HK-53488).
- On 27 Nov 2019, the DH endorsed drug suppliers Cera Medical Limited and Sincerity (Asia) Company Limited to recall Emtac 150 Tab 150mg (HK-59353) and Ranitid 150 Tab 150mg (HK-59429) respectively.
As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons for consideration of any action deemed necessary.
Patients who are taking ranitidine-containing products should seek advice from their healthcare professionals for proper arrangement, e.g. use of alternative medicines with similar uses.
Ends/Saturday, May 2, 2020
Issued at HKT 12:00
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