The Indian Pharmacopoeia Commission (IPC), a statutory body under the ministry of health and family welfare, has found vancomycin injection showing a serious adverse effect called drug reaction eosinophilia and systemic symptoms (DRESS) syndrome.
Vancomycin is a glycopeptide antibiotic medication used to treat bacterial and skin infections.
Vancomycin is available under various brand names in India and required to be sold only under the prescription of a doctor. The drug is manufactured and marketed by multiple companies in India.
AstraZeneca Pharma India Ltd, for instance, markets the drug as Vancocin –CP.
“Vancomycin is used for treatment of serious infection due to Gram-positive cocci including methicillin-resistant staphylococcal infections, brain abscess, staphylococcal meningitis and septicaemia,” said IPC, linking the drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome.
DRESS presents clinically as an extensive mucocutaneous rash, accompanied by fever, lymphadenopathy, hepatitis, hematologic abnormalities with eosinophilia and atypical lymphocytes.
“Healthcare professionals, patients or consumers are advised to closely monitor the possibility of the above ADR associated with the use of above suspected drug. If such a reaction is encountered, please report to the IPC,” it said.
“When we see adverse reactions are due to the use of drugs, it should be reported to the government. IPC examines its frequency and at what percentage adverse reaction a drug is causing,” said one of the state drug controllers requesting anonymity.
IPC monitors adverse drug reactions among Indian population and helps the Central Drugs Standard Control Organization (CDSCO) in taking regulatory decisions for safe use of medicines.
Queries sent to the Union health ministry and AstraZeneca spokesperson remained unanswered till press time.
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