The Therapeutic Goods Administration (TGA) is advising consumers and health professionals that several ranitidine-containing products have been removed from the Australian market due to contamination with an impurity called N‑nitrosodimethylamine (NDMA).
Ranitidine tablets and oral liquids are now in short supply as a number of commonly-used brands have been recalled from pharmacies, hospitals, wholesalers, and other retail outlets, such as supermarkets and online stores. Additional brands may be recalled as the TGA continues testing and discussions with companies that supply ranitidine.
People who use ranitidine may need to switch to alternative therapies because there is a shortage of ranitidine tablets and oral liquids due to the recalls. There are other medicines available to treat heartburn, ulcers and reflux, including prescription medicines and products that can be purchased without a prescription from pharmacies, supermarkets and other retailers.
Ranitidine injection has not been recalled at this time.
Retail level recalls relating to this issue are being undertaken for various strengths, pack sizes and dosage forms for:
- Sandoz ranitidine (marketed under the brand names "Sandoz Ranitidine" and "Mylanta Ranitidine")
- Aspen ranitidine (marketed under the brand name "Zantac")
- Alphapharm ranitidine (marketed under the brand name "RANI 2")
- Apotex ranitidine (marketed under the brand names "APO", "CHEMMART", "TERRY WHITE CHEMISTS" and "APOHEALTH")
- Symbion ranitidine (marketed under the brand names "Pharmacy Choice Acid and Heartburn Relief" / "Extra Strength")
- Cipla Australia ranitidine (marketed under the brand names "AMCAL" and "Pharmacy Care")
- Generic Health ranitidine (marketed under the brand name "Pharmacy Action").
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/ranitidine-0
In Hong Kong, the following ranitidine products are registered pharmaceutical products:
- Ranital Tab 150mg (HK-34755; a Sandoz product currently not available for sale) registered by Novartis Pharmaceuticals (HK) Limited.
- Zantac Syrup 150mg/10ml (HK-30459), Zantac Tab 75mg (HK-41114; currently not available for sale), Zantac Tab 150mg (HK-42792) and Zantac Tab 300mg (HK-42793) registered by GlaxoSmithKline Limited.
- Apo-Ranitidine Tab 150mg (HK-42273) and Apo-Ranitidine Tab 300mg (HK-41873) registered by Hind Wing Co Ltd.
The other products recalled in Australia are not registered pharmaceutical products.
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 European Medicines Agency, the United States Food and Drug Administration (FDA), Health Canada, Singapore Health Sciences Authority (HSA), Australia Therapeutic Goods Administration, Taiwan Food and Drug Administration (TFDA) and Macau Health Bureau, and was posted on the Drug Office website since 16 Sep 2019, with the latest update posted on 2 Oct 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).
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/Friday, Oct 4, 2019
Issued at HKT 16:00
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