The new warning was based on observational studies that found an association between MPA use and meningioma. In one case-control analysis that included 18,061 women who had intracranial surgery for a meningioma over a period of 9 years and 90,305 controls, a significantly greater percentage of patients in the case group had been exposed to injectable MPA for >1 year (0.04% vs 0.01%).1,2 In a retrospective cohort study in >10 million women, use of injectable MPA for >4 years or in those ≥31 years old was associated with a significantly greater risk of meningioma compared to controls (7.39 vs 3.05 cases per 100,000 patient-years; relative risk 2.43 [95% CI 1.77-3.33]). Oral MPA was also associated with an increased risk of meningioma, but to a lesser degree.3

The updated labels recommend monitoring for signs and symptoms of meningioma and stopping the drug if a meningioma is detected.