Ansm article
Progestins and risk of meningioma: strengthening of the prescription and delivery conditions of DEPO Provera 150 mg/3 ml and colprone 5 mg
From July 1 , 2024, the conditions of prescription and issuance (CPD) of medicines based on medroxyprogesterone acetate (DEPO Provera 150 mg/3 ml) and Médrogestone (Colprone 5 mg) are reinforced. This measure follows the recommendations to reduce in patients the risk of meningioma associated with the use of these drugs.
From now on, the dispensation of Depo Provera 150 mg/3 ml and Colprone 5 mg can only be done by the pharmacist if the order is accompanied by an annual certificate of information co-signed by the prescriber and the patient for treatments of more than one year.
A document on all the information to know about these drugs and the implementation of medical follow -up must also be given to patients for any initiation or renewal of treatment.
We continue, in connection with the experts of the temporary scientific committee, to monitor the use of all the progestins vis-à-vis the risk of meningioma.
The labeling of boxes and notices will be updated accordingly by the end of the year. In the meantime, the patients will, from July 1 , 2024, informed of these changes by their health professional at the time of prescription and/or the issuance of these drugs. An informative sticker with a referring QR code to the updated instructions is also affixed to each new medication box.
Information for prescribers
- In the event of a treatment renewal whose anteriority is greater than 1 year:
You must attach to the prescription the annual information certificate co-signed with the patient , and give her a document on all the information to know about these drugs and the implementation of medical monitoring. This co-signed certificate is essential for the issuance of the drug in pharmacies.
In the event of initiation of treatment or renewal of treatment lasting less than 1 year: you must mention “ treatment less than 1 year ” on the prescription and give the patient an information document on all the information to know about these drugs and the establishment of medical monitoring. You can also, if you wish, support the prescription of the annual information certificate co-signed with the patient.
For any prescription carried out before July 1 , 2024, you have until January 1 , 2025 to update the situation of your patients according to these new measures.
Find all of our recommendations on progestins and the risk of meningiom in our file .
Information for pharmacists
To issue the treatment, the patient must present:
- Either the annual information certificate co-signed by the prescriber and the patient and filled if her processing is greater than 1 year;
- Or a prescription with the mention “ Treatment of less than 1 year ” if its treatment is less than 1 year.
If the patient does not have these elements, invite her to get closer to her prescriber so that he gives her the elements necessary for the issuance of her treatment.
For any prescription carried out before July 1 , 2024, these new conditions of prescription and issuance must be respected before January 1, 2025 .
Information for patients processed by Depo Provera or Colprone
If your treatment with DEPO Provera or Colprone 5 mg is renewed beyond 1 year:
- During the consultation, a document on all the information to know about these drugs and the implementation of medical follow -up will be given to you by your prescriber;
- An annual information certificate that you will co-signer with your prescriber will also be given to you;
- When issuing your treatment, you will have to give your pharmacist, in addition to the prescription, the annual information certificate co-signed by your prescriber and yourself. This is a mandatory condition for the medication to you.
If in doubt, contact your prescriber so that it provides you with the elements necessary for the issuance of your treatment.
If your treatment with DEPO Provera or Colprone 5 mg is less than 1 year:
- A document on all the information to know about these drugs and the implementation of medical follow -up will be given to you by your prescriber;
- When issuing your treatment, you will have to give your pharmacist your prescription on which your prescriber will have indicated " treatment less than 1 year ".
If in doubt, contact your prescriber so that it provides you with the elements necessary for the issuance of your treatment.
If your treatment was initiated before July 1, 2024 , you have until January 1 , 2025 to obtain this annual certificate from your prescriber
