Drug-makers to add Candidiasis as adverse event in Patient Information Leaflet of anticancer drug Docetaxal: CDSCO Panel

It is reported that Docetaxel can lead to Candidiasis. Candidiasis is a fungal infection caused by a yeast (a type of fungus) called Candida. Some species of Candida can cause infection in people; the most common is Candida albicans. Candida normally lives on the skin and inside the body, in places such as the mouth, throat, gut, and vagina, without causing any problems.

Chemotherapy-induced suppression of innate immune cells and decreased epithelial barriers, which are the body's first-line defences against fungal infections, are the primary causes of increased susceptibility to such infections in cancer patients.

At a recent SEC meeting for Oncology & Haematology, the recommendation of the signal review panel, PVPI, IPC, was placed before the committee regarding the adverse reaction related to the antineoplastic agent Docetaxel.

In view of the above, after detailed deliberation, the committee recommended,

"CDSCO should request the State Drugs Controllers to direct the manufacturers to include Docetaxel associated Candidiasis as an adverse event in the corresponding prescribing information leaflet"

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