EU warns of brain tumour risk with some contraceptives

EU pharmaceutical safety advisers have said that commonly used contraceptives may carry a small risk of a type of brain cancer with prolonged use, and recommended countermeasures.

The warning from the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) covers contraceptives that include two progestogen components – desogestrel and etonogestrel – which are found in some progestogen-only 'mini pills,' with ethinyloestradiol in combined pills, and in various subdermal implants and vaginal rings.

According to the panel, there is a "small increased risk" of meningioma – the most common type of primary brain tumour – if desogestrel- or etonogestrel-containing contraceptives are used for a year or longer, with the risk increasing with longer duration of use.

The overall likelihood of developing meningioma remains very low, with about one additional case estimated for ​every 67,300 women ​using the ⁠contraceptive medicines, it said.

Meningiomas are tumours of the tissue layer surrounding the brain and spinal cord. Usually, they are benign and grow slowly, but depending on the size or location, they can cause serious problems.

The warning stems from a large French epidemiological study of all women resident in France, regardless of age, published in the British Medical Journal last year. The analysis did not find any evidence of elevated risk with levonorgestrel, another common progestogen used in contraceptive products.

The updated advice from PRAC means that these two progestogens are also contraindicated in women who have a meningioma or have had one in the past.

Meanwhile, women taking them should be monitored for any sign of meningioma, such as "changes in vision, hearing loss or ringing in the ears, loss of smell, worsening headaches, memory loss, seizures or weakness in arms and legs," according to the PRAC.

"If a woman using desogestrel or etonogestrel is diagnosed with meningioma, use of the medicine must be discontinued," it added.

Litfulo warnings strengthened

At its last meeting, the PRAC also tightened up warnings on Pfizer's JAK inhibitor Litfulo (ritlecitinib), used to treat hair loss caused by alopecia areata, to bring its labelling into line with other drugs in the class.

Specifically, Litfulo will now carry warnings of an increased risk of serious side effects, including cardiovascular problems, blood clots, cancer, and serious infections, with a boxed warning that it should be used in some patient groups – such as the over-65s, people with heart conditions, and smokers – only if no suitable treatment alternatives are available.

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