News

Two additional children reported in the TP53 gene mutation dossier

After a fertility centre contacted the Federal Agency for Medicines and Health Products, it emerged that its dossier on the sperm donor carrying the TP53 gene mutation was incomplete, as two additional children were reported. FAMHP inspectors immediately visited the centre for an inspection. The procedure is still underway. The FAMHP considers that the fact that the centre is communicating these elements only now, despite previous information and questions, is very serious.

PRAC June 2025 – The PRAC concluded its review of medicines containing semaglutide and is reviewing the known risk of encephalitis (inflammation of the brain) with two varicella vaccines.

During its June 2025 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded its review of medicines containing semaglutide following concerns regarding a possible increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION). Furthermore, the PRAC is reviewing the known risk of encephalitis (inflammation of the brain) with two varicella (chickenpox) vaccines, Varilrix and Varivax, following a report of a fatal outcome after vaccination with Varilrix.

New: list of unavailable medical devices that could result (a risk of) serious harm

The FAMHP now publishes a list of medical devices and in vitro diagnostic medical devices notified under Article 10bis of regulations (EU) 2017/745 and 2017/746, introduced by the regulation (EU) 2024/1860. In other words, medical devices that are temporarily (interruption) or permanently (discontinuation) absent from the Belgian market and whose unavailability could result in serious harm or a risk of serious harm to patients or public health.

PRAC May 2025 - New risk mitigation measures for finasteride and dutasteride and start of a review of the Ixchiq vaccine

At its May 2025 meeting, the European Medicines Agency Risk Assessment Committee proposed new risk mitigation measures for finasteride and dutasteride. Suicidal thoughts were confirmed as an adverse effect for finasteride, but not for dutasteride. Belgium does not agree with the conclusion. The PRAC also initiated a review of Ixchiq (live attenuated chikungunya vaccine) following reports of serious adverse events in elderly people.