Women who have or have had a meningioma were already banned from using nomegestrol-containing contraceptives. The reason for the new safety measure is an investigation by the safety committee of the European Medicines Agency, the PRAC, which looked at post marketing-data and two recent epidemiological studies. The Committee concluded from this that the risk of meningiomas increases with a high dose and long-term use and that extra measures are therefore required.
A meningioma is a tumor in the meninges of the brain and spinal cord. It is usually benign, but in rare cases the location of the tumor can cause serious problems. Symptoms of a meningioma include blurred vision, double vision, hearing loss, ringing in the ears, loss of smell, memory loss, seizures, and muscle weakness in the arms and legs.
Nomegestrol is available in the Netherlands in combination with estradiol as the contraceptive pill Zoely. This fourth-generation pill consists of a strip of 24 tablets of estradiol and nomegestrol and four placebo tablets.