其 他 安 全 警 示
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| European Union: EMA starts review on screening patients before treatment with fluorouracil, capecitabine, tegafur and flucytosine (English Only) |
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European Medicines Agency (EMA) announces that it has started a review of medicines containing fluorouracil (also known as 5-fluorouracil or 5-FU) and the related medicines capecitabine, tegafur and flucytosine, which are converted to fluorouracil in the body. The review will examine existing screening methods and their value in identifying patients at increased risk of severe side effects.
Fluorouracil (given by injection), capecitabine and tegafur are cancer medicines, whereas topical (applied to the skin) fluorouracil is used for various skin conditions and flucytosine is a medicine used in severe fungal infections.
It is known that some patients lack a working enzyme called dihydropyrimidine dehydrogenase (DPD) which is needed to break down fluorouracil. Prescribers may be unaware that their patients lack working DPD, and if these patients are given fluorouracil or related substances, their bodies cannot break fluorouracil down, resulting in its build-up in the blood. Build-up of high levels of fluorouracil seen with some of these medicines can lead to severe and lifethreatening side effects such as neutropenia (low levels of neutrophils, a type of white blood cells needed to fight infection), neurotoxicity (damage to the body’s nervous system), severe diarrhoea and stomatitis (inflammation of the lining of the mouth). Patients with a complete deficiency of DPD should therefore not be given fluorouracil, or medicines that can form it in the body.
The product information for most of these medicines states that they should not be used in patients with complete DPD deficiency. Genetic testing for DPD deficiency is recommended for most medicines used in the treatment of cancer, but systematic screening for DPD deficiency before starting treatment is not mandatory. In addition, new data on genetic testing and other DPD screening methods were recently published which may impact current recommendations.
EMA will now assess the available data in relation to existing screening methods to detect DPD deficiency and recommend whether any changes are needed to the way these medicines are used in order to ensure their safe use. Patients who have concerns about their medicines should consult their doctor and should not stop taking their medicines without seeking medical advice.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/documents/../fluorouracil-fluorouracil-related-substances-article-31-referral-ema-starts-review-screening_en.pdf
In Hong Kong, there are 4 registered pharmaceutical products containing fluorouracil, 20 products containing capecitabine and 4 products containing tegafur. All products are prescription-only medicines. There is no registered pharmaceutical product containing flucytosine. So far, the Department of Health (DH) has received 86 cases of adverse drug reaction related to fluorouracil, 36 cases related to capecitabine (of which one case is related to dihydropyrimidine dehydrogenase deficiency) and 1 case related to tegafur. The DH has not received any case of adverse drug reaction related to flucytosine. In light of the above EMA’s announcement, letters to inform local healthcare professionals will be issued, and the DH will remain vigilant on the conclusion of the review and any safety updates issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Monday, Mar 18, 2019
Issued at HKT 16:00
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