Androcur: patients with serious tumors long after stopping treatment

A new study confirms concerns around the drug Androcur. Conducted by the Fernand-Widal regional pharmacovigilance center in Paris, it reveals that 4 women suffered from serious intracranial tumors during their pregnancy, several years after having stopped taking the drug.

Drugs often prescribed without marketing authorization

“The occurrence and severity of these four cases raises the question of what action to take in women planning a pregnancy following treatment with Androcur or one of its generics”, indicates the National Agency for the Safety of Medicines (ANSM) . The organization relayed this study on the drug Androcur. She focuses on nearly 300 cases of meningioma reported between 2014 and 2018. The objective of this research was to better understand the risk of intracranial tumor associated with Androcur. In 56% of cases, the drug was prescribed outside the marketing authorization, either as a contraceptive or to treat acne. Patients took the treatment for an average of 14.7 years.

A risk of meningioma multiplied by 20

Since the 1980s, Androcur has been prescribed for hirsutism, abnormal hair growth, severe acne, endometriosis and even as a contraceptive. It can sometimes also be used to treat men with advanced prostate cancer. In the summer of 2018, Health Insurance published an alarming study on the drug: it could increase the risk of intracranial tumors by 20 when taken for 5 years. This risk would be even higher for women treated for a long time with high doses.

From July 1, patient information will become mandatory: all those starting treatment must be informed of the associated tumor risk. An annual information certificate must be signed and each year, the interest of the prescription will be reassessed. These patients will also have to do MRIs, before and during their treatment.

Since the warnings from the National Medicines Safety Agency (ANSM) in October 2018, sales of the drug have fallen by 50%.