IPC asks healthcare professionals to monitor ADRs associated with 5 suspected drugs
The Indian Pharmacopoeia Commission (IPC) which is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) has directed healthcare professionals and patients across the country to report adverse events associated with five suspected drugs – levamisole, cephalosporin, cilostazole, cetirizine and clozapine.
As per the alert from the PvPI, the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database reveals that the drugs – levamisole and cephalosporin- are associated with risks like Stevens Johnson syndrome and acute generalized exanthematous pustulosis respectively.
While Stevens Johnson syndrome is a rare but serious disorder that affects the skin and mucous membranes, acute generalised exanthematous pustulosis is an uncommon pustular drug eruption characterised by superficial pustules.
While levamisole is recommended for treatment and control of mature and developing immature infections of haemonchus, ostertagia, trichostrongylus, cooperia, nematodinus, bunostomum, oesophagastomum and dictyocaulus and all forms of liver fluke infection, cephalosporin is indicated in the treatment of serious infections due to susceptible organisms-respiratory tract infections, urinary tract infections, skin billiary tract infections, septicaemia, meningitis other infections due to susceptible organisms and in the treatment of infections due to penicillin resistant strains of straphylococci.
PvPI also sounded alert for drugs– cilostazole, cetirizine and clozapine based on preliminary analysis of ADRs from its database. As per PvPI alert, 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.
Cilostazole is recommended for the treatment of stable intermittent claudication, acting or cramping in legs that occur with walking while clozapine is indicated in the management of schizophrenic patients. Cetirizine is used for the treatment of allergic rhinitis and chronic urticaria.
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.
The Central Drugs Standard Control Organization (CDSCO) had initiated a nation-wide PvPI in July 2010. Since then, IPC has been mandated to establish clinical evidence between the drug and the ADR event through a robust system of causality assessment.
Source : pharmabiz