EVALUATION OF REPORTED SAFETY DATA FOLLOWING PARACETAMOL USE AMONG INDIAN CHILDREN
Atul Sharma,Shashidhar Rao,Yun Mao
Background : Paracetamol is a widely used antipyretic/analgesic, however a review of reported safety and tolerability data among children in India is limited.
Material : Evaluation of safety data in- Proquest (Embase, Medline, Toxfile and Scisearch), PubMed & Google Scholar databases for the key words as defined in the search criteria among children in India.
Results : Paracetamol is among the most commonly prescribed antipyretic/analgesic for Indian children. Different patterns of paracetamol usage including that to treat febrile episodes and mild to moderate pain have been observed. The majority of studies have reported no clinically significant adverse effects attributable to paracetamol therapy among children in India. Paracetamol has been found to reduce the risk of gastrointestinal bleeding in preterm neonates receiving off-label pharmacologic treatment for patent ductus arteriosus without any significant reported adverse reaction.Additionally, a few published Indian studies that have evaluated interaction of paracetamol on commonly used childhood vaccines have found no evidence of any altered immunological response. Paracetamol use in few studies, has been associated with exposure-dependent risk for the development of eczema and bronchospasm in patients sensitive to aspirin and other NSAIDs. Adverse reactions, although infrequent, in the form of epigastric pain and vomiting have also been reported. Very rare cases of Stevens-Johnson syndrome & allergic rash/angioedema are other reported events. Adverse events like allergic reaction (rash, itching) constipation and dry mouth were associated with intravenous paracetamol and not observed with oral. While the incidence of reported paracetamol overdose is low in India, the potential hepatotoxic effects attributable to over dosage needs to be continually emphasized.
Conclusions : This review demonstrates that the incidence of reported adverse events following use of paracetamol among Indian children is very rare, confirming that paracetamol is a suitable antipyretic and analgesic medicine for many children.
Keywords: Paracetamol India Children
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