The European Medicines Agency (EMA) recommended a Depo-Provera meningioma increased risk warning 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 the meningioma increased risk associated with Depo-Provera.
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 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….
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 a Depo-Provera meningioma increased risk warning in their drug label.
We will watch for developments regarding this Depo-Provera drug safety and legal issue.
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