8legs: Food and drug administration

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FDA approves label change for Depo-Provera, adding brain tumor warning

The FDA approved a label change for Depo-Provera to warn about meningioma risk on the drug’s label.
Pfizer defended the drug’s safety while supporting the label update as a safety measure.
The update follows a lawsuit alleging Pfizer failed to warn about meningioma risks associated with Depo-Provera.
Global agencies previously noted meningioma as a possible side effect with higher-dose progestins.
The decision covers Depo-Provera CI and Depo-Subq Provera 104 injections.
Pfizer’s ongoing legal case claims delayed warning about the risk.
The FDA noted that available observational studies alone do not support a warning for some products.
Regulators in Europe, Canada, and South Africa had already flagged meningioma risks.
The FDA’s latest action specifically affects two versions of the injection.
Pfizer emphasized Depo-Provera’s role in reproductive health despite the warning.

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