Include Albendazole associated diarrhoea in patient information leaflet: 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 anthelmintic drug, Albendazole to include Albendazole associated diarrhoea in the Patient Information Leaflet (PIL) of the marketed products.
This came in line with the recommendation of the signal review panel of Pharmacovigilance Programme of India (PvPI), which was placed before the committee.
Albendazole is a benzimidazole anthelmintic used to treat parenchymal neurocysticercosis and other helminth infections.
Albendazole causes degenerative alterations in the tegument and intestinal cells of the worm by diminishing its energy production, ultimately leading to immobilization and death of the parasite. It works by binding to the colchicine-sensitive site of tubulin, thus inhibiting its polymerization or assembly into microtubules. As cytoplasmic microtubules are critical in promoting glucose uptake in larval and adult stages of the susceptible parasites, the glycogen stores of the parasites are depleted. Degenerative changes in the endoplasmic reticulum, the mitochondria of the germinal layer, and the subsequent release of lysosomes result in decreased production of adenosine triphosphate (ATP), which is the energy required for the survival of the helminth.
Albendazole is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium and for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.
A few brands of Albendazole include Albenza, Alworm, Andazol, Eskazole, Noworm, Zentel, Alben-G, ABZ, Cidazole, Wormnil etc.
At a recent SEC meeting for antimicrobial and antiviral, the recommendation of the signal review panel, PVPI, IPC, was placed before the committee regarding the Albendazole associated diahorrea.
In view of the above, after detailed deliberation, the committee recommended,
"CDSCO should request the State Drugs Controllers to direct the manufacturers of the drug to include Albendazole associated diarrhoea in the PIL of the marketed products."
