The attention of healthcare professionals and citizens is drawn to some safety information, relating to the  risk of acute respiratory distress syndrome (ARDS) associated with the active substance hydrochlorothiazide, missing in the SmPC and in the PL of the medicinal product Rasilez HCT (aliskiren / hydrochlorothiazide).

The Marketing Authorization (MA) of the Rasilez HCT medicinal product is currently revoked, on the initiative of the Marketing Authorization Holder and not for safety reasons, in all European Union Countries (EC Decision C (2021) 9911 ), including Italy, but several product packages are still present on the Italian national market while stocks last.

The safety information on the active substance hydrochlorothiazide, reported in the press release, has recently been updated  with the inclusion of the risk of acute respiratory distress syndrome (ARDS) but this update is not present in the SmPC and in the PL of Rasilez HCT packages still on the market as the drug is revoked.