Therapeutic Goods Administration (TGA) is advising consumers and health professionals that it is aware of international reports of contamination of ranitidine medicines with an impurity called N-nitrosodimethylamine (NDMA). This issue may affect multiple Australian supplied ranitidine products.
NDMA is a type of N-nitroso compound. N-nitroso compounds are commonly found in low levels in a variety of foods, particularly smoked and cured meats, as well as in some drinking water and in air pollution. Long-term exposure, over years, can increase an individual's risk of developing cancer. The additional risk posed by NDMA from ranitidine, at the levels identified to date, is considered to be very low. However, such contamination is considered unacceptable for a medicine. The actual health risks depend on dose and will vary from person to person. The risks from short-term use of ranitidine are expected to be extremely low.
People who use ranitidine products should be aware of this issue. There is no immediate health risk associated with this medication as the risks are associated with long-term use. There are similar medicines to ranitidine that are available over the counter and on prescription in Australia. Individuals who are taking ranitidine without a prescription who are concerned should speak to their pharmacist or doctor about their treatment options. For individuals that have been prescribed ranitidine, the risks of not treating the condition may pose a greater risk to health than the potential contamination with NDMA. Therefore, individuals should continue taking ranitidine until they have spoken to their doctor about an alternative treatment.
Acceptable levels of nitrosamines are set in nanograms (ng). They are based on what is considered safe if a patient continues to take the affected medicine every day over a lifetime of 70 years. The levels of NDMA contamination detected in ranitidine to date, if taken over decades, may modestly increase an individual's risk of developing cancer. While acceptable levels have been derived from animal carcinogenicity studies and incorporate a wide margin of safety, it is not possible to provide an accurate number estimate of the magnitude of carcinogenic risk associated with NDMA contamination based on currently available safety data.
The TGA is working with international regulators and medicine sponsors to investigate this issue. The TGA is also undertaking testing of Australian ranitidine medications to determine if these batches are affected. This issue may lead to a shortage of ranitidine, and potentially alternative medicines used to treat the same conditions. The TGA will publish updated information as it becomes available. In the meantime, if consumers have any questions or concerns about this issue, they should speak to their health professional.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/ranitidine
In Hong Kong, there are 67 registered pharmaceutical products containing ranitidine. These products in the forms of oral preparations and injections are controlled as over-the-counter medicines and prescription-only medicines respectively. So far, 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 European Medicines Agency, the US Food and Drug Administration, Health Canada and Singapore Health Sciences Authority, and was posted on the Drug Office website on 16 Sep 2019 and 17 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.
The DH has been contacting the certificate holder of all registered ranitidine products for follow up on the local impact of the issue. The DH keeps vigilant on the development of the issue and any safety update of the drug issued by overseas drug regulatory authorities for consideration of any action deemed necessary.
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/Wednesday, Sep 18, 2019
Issued at HKT 17:00
|
