EMA’s PRAC Begins Review of Medicines Containing Nomegestrol or Chlormadinone

The European Medicines Agency (EMA)’s Phamacovigilance Risk Assessment Committee (PRAC) has recommended new safety measures for medicines containing nomegestrol or chlormadinone, to minimize the risk of meningioma, which is a tumor of the membranes covering the brain or spinal cord.

PRAC has recommended that medicines containing high-dose chlormadinone (5-10 mg) or high-dose nomegestrol (3.75 – 5 mg) should be used at the lowest effective dose and for the shortest duration possible, and only when other interventions are not appropriate.

Drugs containing nomegestrol or chlormadinone are typically used for gynecological and menstrual disorders, hormone replacement therapy and, at lower doses, as hormonal contraceptives.

Although meningiomas are usually benign, the condition can cause serious problems in rare cases.