IPC Asks To Monitor ADRs Associated With Disulfiram And Fluconazole

PSM News /

Mumbai, 8 Feb 2020:

 

The Indian Pharmacopoeia Commission (IPC) which is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) has directed healthcare institutions and patients across the country to report adverse events associated with two suspected drugs – disulfiram and fluconazole.

 

As per the alert from the PvPI, the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database reveals that the drugs – disulfiram and fluconazole- are associated with risks like skin hyperpigmentation and mouth ulceration respectively.

 

While hyperpigmentation is a condition that causes skin to darken, mouth ulcers are painful sores that can appear inside the mouth and also on the outer lips respectively.

 

While disulfiram is a detoxifying agent & drug used in substance dependence, fluconazole is recommended for the treatment of systemic candidiasis, mucosal candidiasis, pityriasis versicolor, prevention of fungal infections in patients with malignancy.

 

Healthcare professionals and patients have been advised to closely monitor the possibility of the above ADRs associated with the use of these suspected drugs. If such reactions are encountered, it needs to be reported to the NCC-PvPI for suitable action.

 

Earlier PvPI also sounded alert for five suspected drugs-- levamisole, cephalosporin, cilostazole, cetirizine and clozapine. The drugs – levamisole and cephalosporin- are associated with risks like Stevens Johnson syndrome and acute generalized exanthematous pustulosis respectively. Other drugs -- cilostazole and clozapine are associated with the risk of tinnitus and neural tube defects respectively while cetirizine is associated with the risk of hiccups and acute generalised exanthematous pustulosis.

 

The Central Drugs Standard Control Organization (CDSCO) had started PvPI in July 2010 across the country. Since then, IPC has been mandated to establish clinical evidence between the drug and the ADR event through a robust system of causality assessment. Pharmabiz