ANSM: Lotényl and Lotéran: upcoming documents to strengthen patient information

ANSM ANDROCUR

Lotényl and Lotéran: upcoming documents to strengthen patient information

09/02/2021

To support the implementation of the new recommendations for the use of Lutényl, Lutéran, and their generics regarding the risk of meningioma, an information campaign, developed in conjunction with a committee of physicians and representatives from patient associations, is being prepared. Inspired by the communication tools implemented in 2019 to significantly reduce the use of another progestin medication associated with an increased risk of meningioma (Androcur and its generics), the information campaign will initially focus on two tools:

  • An information document to be given to each patient starting or continuing treatment . This document will explain what a meningioma is and outline the level of risk depending on the treatment taken. It will warn of the clinical signs that may be associated with the presence of a meningioma and specify the appropriate course of action for each situation (reassessments at least once a year of the treatment's relevance, conditions for performing brain imaging, etc.).
  • An annual information form to be completed by the patient and her doctor  will facilitate communication during consultations and ensure that women are informed about both the benefit/risk ratio of these medications and the imaging follow-up procedures in the event of treatment. This information form will need to be presented at the pharmacy to obtain the medication, under conditions yet to be specified.

These documents will be available during spring.

In connection with the CNAM we study the possibility of sending an individual letter to the doctors who prescribed Lotényl or Lotéran and their generics to invite them to regain contact with the patients concerned in order to re-evaluate the merits of their treatment. In parallel, patients would also receive a personal letter inviting them to consult their doctor.

All of these tools will help limit the use of these drugs to situations only for which their prescription is justified.