其 他 安 全 警 示
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| European Union: New measures to minimise risk of meningioma with medicines containing nomegestrol or chlormadinone (English only) |
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The European Medicines Agency (EMA) announces that its human medicines committee (CHMP) has endorsed the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the benefits of medicines containing nomegestrol or chlormadinone outweigh the risks, provided new measures are taken to minimise the risk of meningioma.
A meningioma is a tumour of the membranes covering the brain and spinal cord. It is usually benign 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.
The CHMP has recommended that medicines containing high-dose nomegestrol (3.75 – 5 mg) or high-dose chlormadinone (5 – 10 mg) should be used at the lowest effective dose and for the shortest duration possible, and only when other interventions are not appropriate. In addition, low- and high-dose nomegestrol- or chlormadinone-containing medicines must not be used by patients who have, or have had, meningioma.
As well as restricting the use of the high-dose medicines, the CHMP has recommended that patients should be monitored for symptoms of meningioma, which can include change in vision, hearing loss or ringing in the ears, loss of smell, headaches, memory loss, seizures and weakness in arms or legs. If a patient is diagnosed with meningioma, treatment with these medicines must be permanently stopped.
The product information for the high-dose medicines will also be updated to include meningioma as a rare side effect.
The CHMP opinion has been sent to the European Commission, which will issue a legally binding decision valid across the EU.
Information for healthcare professionals:
- Meningiomas (single and multiple) have been reported with the use of nomegestrol- or chlormadinone-containing medicines, particularly at high doses and for prolonged time. The risk increases with increasing cumulative doses.
- The use of these medicines at high doses should be restricted to situations where other interventions are considered inappropriate, and they should be used at the lowest effective dose and for the shortest duration.
- Nomegestrol- or chlormadinone-containing medicines are contraindicated in patients with meningioma or a history of meningioma.
- Patients should be monitored for signs and symptoms of meningiomas in line with clinical practice. If a patient is diagnosed with meningioma, treatment with these medicines should be permanently stopped.
- Available evidence suggests that the risk of meningioma decreases after treatment discontinuation of the nomegestrol- or chlormadinone-containing medicine.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/new-measures-minimise-risk-meningioma-medicines-containing-nomegestrol-chlormadinone
Local Situation in Hong Kong: In Hong Kong, there is no registered pharmaceutical product 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. Related news was previously issued by EMA, and was posted on the Drug Office website on 2 Oct 2021 and 9 Jul 2022. Letters to inform local healthcare professionals were issued by the DH on 11 Jul 2022. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, Sep 3, 2022
Issued at HKT 12:00
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