ADR that result in revision of patient information
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| European Union: EMA recommends measures to minimise the risk of meningioma with medicines containing medroxyprogesterone acetate |
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European Medicines Agency (EMA) announces that its safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), has recommended measures to minimise the risk of meningioma, a type of brain tumour, with medicines containing medroxyprogesterone acetate.
These medicines are used for gynaecological (including contraception and endometriosis) and oncological indications.
Meningiomas are tumours of the tissue layer surrounding the brain and spinal cord. Usually they are benign (non-cancerous) and grow slowly but, depending on the size or location, they can cause serious problems.
The committee’s recommendations followed a review of data from epidemiological studies, case studies from the medical literature and cases reported in the pharmacovigilance database of the European Union. These data show an increased risk of meningioma in people taking high doses of medroxyprogesterone acetate (injectables and ≥100 mg tablets) for several years. Although the relative risk of meningioma is significantly increased with the use of high-dose medroxyprogesterone acetate, the absolute risk is very small.
PRAC recommended that, in patients who have a meningioma or have had one in the past, medicines containing high-dose medroxyprogesterone acetate must not be used, unless medroxyprogesterone acetate is needed for the treatment of an oncological indication.
PRAC also recommended that patients taking high doses of medroxyprogesterone should be monitored for symptoms of meningioma, which can include change in vision, hearing loss or ringing in ears, loss of smell, headaches, memory loss, seizures and weakness in arms and legs. If a patient treated for a non-oncological indication is diagnosed with meningioma, treatment with high-dose medroxyprogesterone acetate must be stopped. If a patient treated for an oncological indication is diagnosed with meningioma, the need for further treatment with high-dose medroxyprogesterone should be carefully considered, on a case-by-case basis, taking into account individual benefits and risks.
The product information for medicines containing high-dose medroxyprogesterone acetate will be updated to include meningioma as a possible side effect of unknown frequency.
The PRAC has agreed a direct healthcare professional communication (DHPC) to inform healthcare professionals of the increased risk of developing meningioma with high doses of medroxyprogesterone acetate (all injectable and ≥100 mg oral formulations), primarily after prolonged use (several years). The DHPC will highlight that medicines containing high doses of medroxyprogesterone acetate, when used for contraception or non-oncological indications, are contraindicated in patients with meningioma or with a history of meningioma. If a meningioma is diagnosed in a patient treated with high doses medroxyprogesterone acetate, treatment must be stopped.
If a meningioma is diagnosed in an oncological patient treated with high doses medroxyprogesterone acetate, the need to continue the treatment should be carefully reconsidered, on a case-by-case basis taking into account individual benefits and risks.
Patients treated with high doses medroxyprogesterone acetate should be monitored for signs and symptoms of meningioma in accordance with clinical practice.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-2-5-september-2024
In Hong Kong, there are 10 registered pharmaceutical products containing medroxyprogesterone acetate and 6 of them contain high doses of medroxyprogesterone acetate (injectable and ≥100 mg oral formulations). All products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reactions related to medroxyprogesterone acetate. In light of the above EMA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Saturday, Sep 7, 2024
Issued at HKT 12:15
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