Widely used life-saving antibiotic Meropenem manufactured by Pfizer and other leading pharmaceuticals firms, can have adverse reactions, the Union government’s Indian Pharmacopoeia Commission (IPC) has found, and advised doctors and patients to be careful while using the drug.
The Union health and family welfare ministry’ body is of the view that Meropenem usage can lead to adverse reactions in patients in the form of Acute Generalized Exanthematous Pustulosis (AGEP), a severe drug related reaction, and can be life threatening.
The medication is largely prescribed by doctors for the treatment of pneumonia, UTI, intra-abdominal infection, skin infection, meningitis, septicaemia and gynecological infections among others.
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Meropenem drug is available under various brand names in India. The medicine falls under the schedule H and H1 of the drugs and cosmetic rules, 1945 and required to be sold by retail only under the prescription by a doctor.
“The analysis of adverse drug reactions from Pharmacovigilance Programme of India (PvPI) database revealed that Meropenem drug to cause adverse drug reaction,” stated IPC’s drug safety alert reviewed by Mint.
‘Closely monitor situation’
“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.
“The pack inserts in Pfizer’s meropenem drug formulation already contains safety alert for acute generalised exanthematous pustulosis (AGEP). Patient Safety is our priority and we are committed to working with authorities to deliver quality products that meet the highest standards of safety and efficacy,” Pfizer’s spokesperson said.
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“Whenever adverse reactions are reported due to the use of drugs that must be reported to the government,” 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.
Meanwhile, to regulate the misuse of antibiotics the regulator Drugs Controller General of India has directed states/UT governments to keep a close watch on the sale of inappropriate antibiotic combinations currently in the market and these should be banned immediately. It has further instructed the officials not to let these cocktail drugs find their way into the market.
The regulator has sought a detailed report of licensed antibiotics available for sale from the drug controllers in the state.
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Published: 05 Jun 2024, 08:10 PM IST