Injectable azacitidine-related vasculitis.

The Malaysian National Pharmaceutical Regulatory Agency (NPRA) is warning healthcare professionals about the risk of cutaneous leucocytoclastic vasculitis after administering injectable azacytidine. Cutaneous vasculitis is inflammation of small or medium-sized blood vessels in the skin. The European Medicines Agency (EMA) has requested that product registration holders of azacitidine-containing injectable formulations update their package inserts with information about cutaneous vasculitis. The NPRA has received reports of adverse events related to azacitidine, but no cases of cutaneous vasculitis have been reported in Malaysia. Healthcare professionals should be aware of the potential risk and inform patients to seek medical attention if they experience unusual or worsening skin symptoms after receiving azacitidine. The NPRA has issued a directive for registration holders to update package inserts with this safety information. There is currently no evidence to update package inserts for oral azacitidine products, but the NPRA will continue to monitor the safety profiles of all azacitidine products. [Extracted from the article]