The drug cyproterone is being investigated by the European Medicines Agency (EMA) for possible links to patients developing a specific type of tumour.
Meningioma is a largely non-malignant tumour of the membranes that cover the brain and spinal cord in humans.
Cyproterone patients, being treated with the drug for androgen-based conditions such as Female Pattern Hair Loss, hirsutism, acne, endometriosis and as part of hormone replacement therapy, including during male to female transitioning, may potentially have an increased risk of developing these rare tumours.
Known risk may be higher than first thought
The possible links to meningioma were established in 2008 and have been listed as a known possible adverse event on cyproterone patient information leaflets and prescribers' information since then.
Patients who have already been previously diagnosed with meningioma are already advised not to take this medication.
However, France - which has voiced these concerns for the past year - has requested the latest review of the drug given its data suggests the risk of these side effects may be higher than previously reported when long-term use is considered.
The French noted that a recent study carried out in their country showed patients using medications containing cyproterone or cyproterone acetate, such as Bayer's Androcur, still had a higher risk of developing meningioma even one year - or more - after finishing treatment.
The EMA, according to MedScape, will receive a report and recommendations on the matter from its Pharmacovigilance Risk Assessment Committee (PRAC), in November 2019.
Side effects of tumour removal
Whilst meningioma is rarely malignant, there are a host of side effects associated with its surgical removal; patients risk developing memory loss, epilepsy, and losing their sense of taste and/or smell.
The EMA, which is the European equivalent of the UK's MHRA and the FDA in the USA, is carrying out an investigation as the drug is largely used in European countries.
The oral tablet has not been marketed in the USA nor Japan, although it is used in the UK for some conditions.
It is not, however, meant to be used to treat Female Pattern Hair Loss in the UK; this common genetic hair loss condition which presents as thinning hair along the top of the scalp and temporal areas is caused by an inherited sensitivity to the androgen hormone DHT. It is also known as androgenic or androgenetic alopecia.
Currently high strength minoxidil is the only clinically-proven, MHRA-licensed women's hair loss treatment available for androgenic alopecia.
This is a topical drug which comes in a range of formulations designed to encourage localised hair growth and can be used alongside additional hair growth supporting products, as recommended by a professional hair loss specialist based on their findings and the individual's specific medical needs.
Due to the relative ease at which illegal, counterfeit and mislabeled prescription medication can be purchased online without the relevant medical information and authorisations, situations such as this remind people to only purchase appropriate, prescribed treatments for any health issue from reputable, licensed pharmacies.
Not only will that ensure you are receiving genuine medication that is suitable for your specific situation but they will warn you of any potential issues - often being able to contact you about such matters even if you are no longer taking the medication.