The US Food and Drug Administration (FDA) announces that it has asked manufacturers of ranitidine and nizatidine products to expand their testing for NDMA to include all lots of the medication before making them available to consumers. If testing shows NDMA above the acceptable daily intake limit (96 nanograms per day or 0.32 parts per million for ranitidine), the manufacturer must inform the agency and should not release the lot for consumer use.
FDA continues to work with industry and regulatory agencies around the world to determine the reasons for NDMA in these drugs and have developed and posted multiple testing methods to identify NDMA in ranitidine. FDA’s scientists have determined ranitidine does not form NDMA in typical stomach conditions. However, FDA needs further investigation to fully test how ranitidine and nizatidine behave in the human body and have plans to study this. There is also some evidence that there may be a link between the presence of nitrites and the formation of NDMA in the body if ranitidine or nizatidine is also present. Because of this, consumers who wish to continue taking these drugs should consider limiting their intake of nitrite-containing foods, e.g. processed meats and preservatives like sodium nitrite.
Consumers may also consider alternative treatments that are approved for the same or similar uses as ranitidine and nizatidine. To date, FDA’s testing has not found NDMA in Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), or Prilosec (omeprazole).
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
In Hong Kong, there is no registered pharmaceutical product containing nizatidine.
Currently, there are 67 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 N-nitrosodimethylamine (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 25 Nov 2019. Letters to inform local healthcare professionals were issued by the DH on 18 Sep 2019. 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 for consideration of any action deemed necessary.
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.
Patients who are taking ranitidine-containing products should not stop taking the medicines, but should seek advice from their healthcare professionals for proper arrangement, e.g. use of alternative medicines with similar uses.
Ends/ Thursday, Dec 5, 2019
Issued at HKT 16:00
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