The European Medicines Agency (EMA) recommended a Depo-Provera warning about meningioma in September 2024. One wonders why the FDA has not followed this EMA regulatory action. Therefore, the Depo-Provera drug label in the US still does not include a warning about meningioma.
The following information about the Depo-Provera warning about meningioma in Europe comes from this EMA document, “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2024”:
The PRAC has recommended measures to minimise the risk of meningioma, a type of brain tumour, with medicines containing medroxyprogesterone acetate [such as Depo-Provera]….
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.
An important issue in the increasing number of Depo-Provera meningioma drug injury lawsuits will be why the drug companies responsible for Depo-Provera used by women in the US did not, and still do not, include any Depo-Provera warning about meningioma in their drug label.
We will watch for developments regarding this Depo-Provera drug safety and legal issue.
[Read the article in full at source]Depo-Provera Contraceptive Injection
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