Other safety alerts
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| Australia: Safety advisory: Fluoxetine: Presence of low levels of N‑nitrosofluoxetine |
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Therapeutic Goods Administration (TGA) is investigating the presence of low levels of the nitrosamine impurity known as N‑nitrosofluoxetine in medicines containing fluoxetine.
TGA determines acceptable intake (AI) limits for nitrosamines in medicines to ensure that these impurities do not pose a safety concern for patients. TGA has set an AI limit for N-nitrosofluoxetine over a lifetime exposure (i.e. long-term exposure). Some Australian sponsors of fluoxetine products have reported that their products currently contain levels of N-nitrosofluoxetine that are higher than this limit. TGA has determined that there are no health concerns associated with the short-term use of these medicines. Nitrosamine impurities also affect fluoxetine products supplied overseas, and TGA’s approach is similar to other regulators such as the European Medicines Agency.
Alphapharm Pty Ltd, the sponsor that supplies Zactin Tabs (fluoxetine 20 mg dispersible tablets), has provided information to TGA that this product contains levels of N-nitrosofluoxetine above the temporary higher limit. As a precautionary measure, Alphapharm has paused distribution of the product and recalled stock from wholesalers while this issue is investigated.
Fluoxetine capsule products remain available.
N-nitrosofluoxetine is a type of nitrosamine that is present as an impurity. Nitrosamines are a group of compounds which can damage DNA. They are commonly found in low levels in a variety of foods, including smoked and cured meats, dairy products, vegetables, 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 that would be posed by the trace levels of N-nitrosofluoxetine being detected in fluoxetine is likely to be very low. However, the presence of nitrosamine impurities is generally considered unacceptable for a medicine. The actual health risk depends on the medicine and dose taken and will vary from person to person.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-alerts/safety-advisory-fluoxetine
In Hong Kong, Zactin Tabs is not a registered pharmaceutical product.
There are 22 registered pharmaceutical products containing fluoxetine in Hong Kong. All products are prescription-only medicines. So far, the Department of Health (DH) has received 22 cases of adverse drug reaction related to fluoxetine. None of them is concluded to be related to the presence of N-nitrosofluoxetine. The DH will remain 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 fluoxetine-containing products should not stop taking the medicines unless advised by their prescribers.
Ends/Tuesday, Nov 28, 2023
Issued at HKT 15:00
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