As you can all see below, they said they will share my query and the petition with the committee, I urge you to share this petition so it can gain more traction.

In the next email I will send you a draft of an email we will all send to the European medicine agency with this petition attached, please this is important and it could have a real impact on the decision.

IT: Come potete vedere qui sotto, hanno detto che condivideranno la mia domanda e la petizione con la commissione, vi esorto a condividere questa petizione in modo che possa ottenere maggiore diffusione.

Nella prossima e-mail vi invierò una bozza di un'e-mail che tutti noi invieremo all'Agenzia Europea del Farmaco con allegata questa petizione, per favore è importante e potrebbe avere un impatto reale sulla decisione.

"Dear Mr De Simone,

Thank you for sending your query to the European Medicines Agency (EMA) regarding the review of medicines containing finasteride and dutasteride. We are sorry to hear that you are concerned about it.

EMA has indeed started a safety review of all medicines containing finasteride and dutasteride marketed in the European Union (EU). A communication was published on EMA’s website to explain the reasons and objectives of the review: https://www.ema.europa.eu/en/medicines/human/referrals/finasteride-dutasteride-containing-medicinal-products

The review was triggered because there were concerns that the medicines may cause suicidal ideation (thoughts) and behaviours.

Finasteride and dutasteride already have well known psychiatric side effects. For example, some of the medicines that are taken by mouth (tablets or capsules) can cause depression and sexual disorders. Recently, suicidal ideation was added as a possible side effect for two finasteride medicines.

EMA’s safety committee will now investigate suicidal ideation and behaviours. The committee will review all data potentially linking finasteride spray, finasteride 1 or 5 mg tablets and dutasteride 0.5 mg capsules to suicidal ideation and behaviours, and review whether the benefits of the medicines outweigh the risks for patients with alopecia and benign prostatic hyperplasia. The data considered include a review of the literature, suspected side effects reported in the EU database (EudraVigilance) and answers from the companies to a list of questions. The list of questions and the review of cases in EudraVigilance are available as a PDF at the bottom of the referral’s webpage. The link to this document is provided here for your convenience: Finasteride-dutasteride Art 31 PhV - PRAC List of questions

EMA cannot predict the outcome of the review. As for any safety review, it is possible that the medicines may remain available as they are or that additional safety measures are put in place to minimise the risks. A recommendation to withdraw the medicine from the market is only taken when EMA determines that the risks outweigh the benefits, and no further measures are possible to reduce the risks.

Please note that the recommendations, if any, may not be the same for all uses (alopecia or benign prostatic hyperplasia), forms (spray, tablets or capsules) and strengths.

I would like to reassure you that EMA’s safety committee is well aware of the social and psychological impact of alopecia. All parameters will be taken in consideration during the review, including the benefits of the medicines for the patients.

Once the review is completed, EMA’s safety committee will issue a recommendation which will be published on the EMA website. It will also be sent to the CMDh, a group which represents all Member States of the European Economic Area (EEA). The CMDh will discuss the recommendation of EMA's safety committee. If there is consensus, it will issue a legally binding position, which will apply in the EEA. If there is no consensus, the European Commission will issue a decision valid in the EU.

We would like to inform you that the information you provided in your query number ASK-268485 will be shared with EMA’s safety committee for consideration in its assessment, as relevant. Please note that in line with applicable legislation, it may also be shared with companies marketing the medicines in the EU that are involved in the ongoing safety review as it could potentially affect its outcome.

Due to the nature of your query, we kindly ask you to answer this email to let us know if you agree for its content to be shared with EMA’s safety committee and the companies in its current form. Alternatively, you can also propose a version which you would agree to be shared where any commercial confidential information and/or personal data (e.g. name, signature) are redacted."

As you can all see they said they will share my query and the petition with the committee, I urge you to share this petition so it can gain more traction.