BRUSSELS: Millions of women using hormonal contraceptives containing desogestrel and etonogestrel may soon see updated safety warnings after Europe's medicines regulator concluded that prolonged use of these widely prescribed birth control medicines is associated with a small increased risk of meningioma, a usually non-cancerous tumor that develops in the membranes surrounding the brain and spinal cord.
The European Medicines Agency (EMA) announced the recommendations following a review by its Pharmacovigilance Risk Assessment Committee (PRAC), which evaluated evidence from a large French epidemiological study. While the committee confirmed a small increase in risk with long-term use, it stressed that the overall likelihood of developing a meningioma remains very low.
The updated guidance is expected to affect product information for contraceptive pills, implants and vaginal rings containing these hormones across the European Union.
What are desogestrel and etonogestrel?
Desogestrel and etonogestrel are synthetic progestins, hormones commonly used in modern contraceptives.
Desogestrel is primarily available in progestin-only oral contraceptive pills.
Etonogestrel is used in contraceptive implants and certain vaginal rings, often in combination with estrogen.
These medicines are prescribed worldwide because they are among the most effective methods of preventing pregnancy.
What did the EMA find?
After reviewing the latest scientific evidence, the EMA concluded that women using desogestrel- or etonogestrel-containing contraceptives for prolonged periods face a small but measurable increase in the risk of intracranial meningioma.
The risk appears to increase with longer duration of use and may be higher in women who have previously taken other progestogen medicines already associated with meningioma, including:
• Cyproterone
• Nomegestrol
• Medroxyprogesterone
• Chlormadinone
Despite the finding, the regulator emphasized that the condition remains rare.
Current estimates suggest there is approximately one additional case of meningioma for every 67,300 women using these medicines, highlighting that the absolute risk remains extremely low.
What is a meningioma?
A meningioma is a tumor that develops from the meninges—the protective membranes covering the brain and spinal cord.
Most meningiomas are benign (non-cancerous) and grow slowly. However, depending on their size and location, they can place pressure on nearby brain tissue or nerves, potentially causing serious neurological symptoms.
Possible warning signs include:
• Persistent or worsening headaches
• Changes in vision
• Hearing loss or ringing in the ears
• Loss of smell
• Memory problems
• Seizures
• Weakness or numbness in the limbs
The EMA advises women using these contraceptives to seek medical attention if they experience any of these symptoms.
Who should not use these contraceptives?
The regulator now recommends that women with a current or previous history of meningioma should not use contraceptives containing desogestrel or etonogestrel.
If a woman is diagnosed with a meningioma while taking either medicine, healthcare professionals should discontinue treatment and consider appropriate alternative contraceptive options.
The EMA also recommends that clinicians carefully review patients' medical histories before prescribing these medicines, particularly if they have previously used other progestogen-containing medications associated with meningioma.
New warnings to appear on product labels
Following the safety review, the EMA has recommended updating prescribing information for medicines containing desogestrel and etonogestrel throughout the European Union.
The revised product information will:
• List meningioma as a possible adverse effect with unknown frequency.
• Include strengthened safety warnings.
• Add a contraindication for women with a current or previous history of meningioma.
Healthcare professionals will also receive updated prescribing guidance to support informed decision-making and patient counseling.
Should women stop taking their contraceptives?
The EMA is not advising women to stop taking their contraceptives on their own.
Instead, the agency emphasizes that the benefits of these contraceptives continue to outweigh their risks for most women when used appropriately.
Women who have concerns about their contraceptive method or who develop neurological symptoms are encouraged to consult their doctor before making any changes to treatment.
Experts caution that abruptly discontinuing contraception without medical advice may increase the risk of unintended pregnancy.
Why this matters
Hormonal contraceptives are among the most commonly prescribed medicines worldwide, making even rare safety findings important for patients, clinicians and regulators.
The latest recommendations highlight the importance of ongoing post-marketing drug safety surveillance, which allows regulators to detect uncommon adverse effects that may only become apparent after medicines have been used by large populations over many years.
For healthcare professionals, the new guidance reinforces the need for individualized contraceptive counseling, careful assessment of medical history and prompt investigation of persistent neurological symptoms.
For women, the message is one of awareness—not alarm. While the risk of meningioma remains extremely low, understanding the updated safety advice can help patients make informed decisions in partnership with their healthcare providers.
As the EMA moves to update product labeling across Europe, the recommendations are likely to be closely watched by regulators, clinicians and public health authorities around the world.
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