New regs to minimize risk of nomegestrol or chlormadinone meds

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended new measures to minimize the risk of meningioma with medicines containing nomegestrol or chlormadinone, which are used for gynecological and menstrual disorders, hormone replacement therapy and, at lower doses, as hormonal contraceptives (birth control).

Meningioma is a tumor of the membranes covering the brain and spinal cord. It is usually benign and is not considered to be a cancer, but due to their location in and around the brain and spinal cord, meningiomas can in rare cases cause serious problems.

The 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. In addition, low- and high-dose nomegestrol or chlormadinone medicines must not be used by patients who have, or have had, meningioma.