Why Has This September 2024 European Medicines Agency (EMA) Action Not Been Followed by FDA in US?
(Posted by Tom Lamb at Drug Injury Watch)
One of the primary issues in the increasing number of Depo-Provera meningioma lawsuits will likely be why the drug label in the US still does not include a meningioma warning. Lawyers who are starting to prepare these cases for court trials in the future will probably explore the fact that the European Medicines Agency (EMA) recommended a meningioma warning for Depo-Provera (medroxyprogesterone acetate) back in September 2024.
The following information about the September 2024 drug regulator action on this Depo-Provera meningioma warning is found in this EMA document: "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2024."
We begin with this excerpt from the section titled "New recommendations to minimise the risk of meningioma with medicines containing medroxyprogesterone acetate":
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. 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....
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Next, from the section titled "Medroxyprogesterone: increased risk of meningioma with high doses and after prolonged use" in that same September 2024 EMA document:
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.
One wonders why the FDA has not followed this EMA regulatory action since it was taken in September.
But the more important question in these Depo-Provera meningioma 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 meningioma warning in their drug label.
We will monitor the drug regulatory realm for further developments regarding the Depo-Provera drug label and watch the Depo-Provera meningioma lawsuits to learn more about this issue.
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