EU Regulator Warns of Small Brain Tumor Risk with Desogestrel and Etonogestrel Contraceptives

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has agreed on new safety information for contraceptives containing desogestrel and etonogestrel, indicating a small increased risk of meningioma (a type of brain tumor) with current, prolonged use (over one year). While the overall likelihood of developing meningioma remains very low, these medicines are now contraindicated in women with a current or past history of meningioma, and patients should be monitored for symptoms such as vision changes, hearing loss, or worsening headaches.

Context

Desogestrel and etonogestrel are progestin-only contraceptives commonly prescribed for birth control. The European Medicines Agency's Pharmacovigilance Risk Assessment Committee has identified a small increased risk of developing meningioma with prolonged use of these contraceptives. Meningioma is a type of brain tumor that can have serious health implications, although the overall risk remains low.

Why it matters

This warning from the EU regulator highlights potential health risks associated with widely used contraceptives. Understanding these risks is crucial for informed decision-making among women considering these options. The contraindication for women with a history of meningioma underscores the importance of personalized medical advice in contraceptive use.

Implications

Women using desogestrel and etonogestrel may need to reconsider their contraceptive options, particularly those with a history of brain tumors. This development could lead to increased scrutiny of contraceptive safety and potential changes in regulatory guidelines. The warning may also impact the prescribing habits of healthcare professionals, as they weigh the benefits and risks of these contraceptives.

What to watch

Healthcare providers may begin to adjust their prescribing practices in light of this new information. Patients currently using these contraceptives should discuss their options with their doctors, especially those with a history of meningioma. Monitoring for symptoms related to meningioma will likely become a standard part of care for women using these medications.