Drug-makers to add Candidiasis as adverse event in Patient Information Leaflet of anticancer drug Docetaxal: CDSCO Panel
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has recommended that CDSCO may request State Drugs Controllers to direct the manufacturers of antineoplastic agent Docetaxel to include Docetaxel associated Candidiasis as an adverse event in the corresponding prescribing information leaflet.
This came in line with the recommendation of the signal review panel of National Coordinating Centre(NCC) -Pharmacovigilance Programme of India (PvPI), which was placed before the committee.
Docetaxel is a taxoid antineoplastic agent used in the treatment of various cancers, such as locally advanced or metastatic breast cancer, metastatic prostate cancer, gastric adenocarcinoma, and head and neck cancer.
Docetaxel has a unique mechanism of action as an inhibitor of cellular mitosis and that currently plays a central role in the therapy of many solid tumors including breast and lung cancer. Docetaxel therapy is frequently associated with serum enzyme elevations which are usually transient and mild, but more importantly has been linked to rapid onset, severe hypersensitivity reactions that can be associated with acute hepatic necrosis, liver failure and death.
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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