其 他 安 全 警 示
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| European Union: EMA starts review of meningioma risk with nomegestrol- and chlormadinone-containing medicines (English only) |
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The European Medicines Agency (EMA) announces that it has started a review of medicines containing the active substance nomegestrol or chlormadinone. These medicines can be used, alone or in combination with other active substances, to treat gynaecological disorders such as amenorrhea (absence of menstrual periods) and other menstrual disorders, uterine bleeding, endometriosis (a condition in which tissue similar to the lining of the womb grows elsewhere in the body), breast tenderness, as hormone replacement therapy or as contraceptives (birth control).
The review was requested by the French medicines agency (ANSM) following new data from two epidemiological studies carried out in France in women taking these medicines to investigate the risk of meningioma, a tumour of the membranes covering the brain and spinal cord. This tumour is usually non-malignant and is not considered to be a cancer, but due to their location in and around the brain and spinal cord, meningiomas can in rare cases cause serious problems.
In light of these new data concerning the risk of meningioma, EMA's safety committee (PRAC) will now examine the available evidence and make recommendations as to whether the marketing authorisations for nomegestrol- and chlormadinone-containing medicines should be amended across the EU.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/ema-starts-review-meningioma-risk-nomegestrol-chlormadinone-containing-medicines
In Hong Kong, there is no registered pharmaceutical products containing nomegestrol. There is 1 registered pharmaceutical product (HK-65918) containing chlormadinone in combination with ethinyloestradiol in tablet dose form. The product is a prescription-only medicine. So far, the Department of Health (DH) has not received cases of adverse drug reaction related to chlormadinone. In light of the above EMA’s announcement, 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/ Saturday, October 02, 2021
Issued at HKT 12:30
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