Ocrevus, safety notice on risk of liver damage: what the monitoring requires

On October 8, 2026, Roche issued, in agreement with the European Medicines Agency (Ema) and the Italian Medicines Agency (Aifa), a safety information notice on Ocrevus, the trade name of ocrelizumab, a drug approved for the treatment of relapsing-remitting and primary progressive multiple sclerosis, administered intravenously or subcutaneously twice a year.

The notice concerns the risk of drug-induced liver damage. According to the report, the review of safety data showed that most of the recorded cases were not serious, but in some episodes the liver damage manifested in a severe or potentially life-threatening form, with markedly elevated levels of transaminases and bilirubin. In some of these cases, patients were temporarily placed on a waiting list for liver transplantation before the liver damage resolved.

Based on these elements, the notice recommends — a recommendation jointly attributed to Roche, Ema and Aifa — monitoring patients’ liver function both before starting treatment and during its course. The available material does not specify the total number of recorded cases, the time period over which the data were collected, or the reference population on which the safety review was conducted: these are details that cannot be reported because they are not present in the source consulted.

It should be noted that the news currently comes from a single source (FarmaciaVirtuale.it, which reproduces the notice issued by Roche, Ema and Aifa); no independent confirmation has been found, for example through Aifa’s institutional website or a direct Ema statement, that would allow independent verification of the numerical details of the safety signal.

The notice does not suspend the drug nor does it modify its approved therapeutic indications: it introduces a procedural requirement, periodic monitoring of liver function, in the clinical management of patients already undergoing treatment or candidates to begin it.