The widely used life-saving antibiotic Meropenem, manufactured by Pfizer and other major pharmaceutical firms, may have adverse reactions, the Union government’s Indian Pharmacopoeia Commission (IPC) has found and advised doctors and patients to be cautious while taking it. use of the drug.
The body of the Union Ministry of Health and Family Welfare is of the opinion that the use of Meropenem may lead to adverse reactions in patients in the form of Acute Generalized Exanthematous Pustulosis (AGEP), a serious drug-related reaction and may life threatening life.
It is mainly prescribed by doctors for the treatment of pneumonia, intra-abdominal infections, skin infections, meningitis, septicemia and gynecological infections, among others.
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The drug Meropenem is available under different brand names in India. The drug falls under Schedule H and H1 of the Drugs and Cosmetics Regulations, 1945 and is required to be sold by retail only with a doctor’s prescription.
“Analysis of adverse drug reactions from the Pharmacovigilance Program of India (PvPI) database revealed that the drug Meropenem may cause adverse drug reactions,” said the IPC drug safety alert, reviewed by Mint.
‘Closely monitor the situation’
“Healthcare professionals, patients or consumers are advised to closely monitor the possibility of the above ADR related to the use of the above suspected drug. If such a reaction is encountered, please report it to the IPC,” the notice said.
“Pfizer’s meropenem formulation package inserts now contain the safety alert for acute generalized exanthematous pustulosis (AGEP). Patient safety is our priority and we are committed to working with the authorities to provide quality products that meet the highest standards high levels of safety and efficacy,” said the Pfizer spokesperson.
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“Whenever adverse reactions are reported due to the use of drugs they should be reported to the government,” said one of the state’s drug controllers, requesting anonymity.
The IPC monitors adverse drug reactions among the Indian population and assists the Central Drug Standards Control Organization (CDSCO) in making regulatory decisions on the safe use of drugs.
Meanwhile, to regulate the misuse of antibiotics, the Drug Controller General of India has directed the state/UT governments to closely monitor the sale of inappropriate combinations of antibiotics currently in the market and these should be stopped immediately. Further, it has instructed officials not to allow these cocktail drugs to enter the market.
The regulator has requested a detailed report of licensed antibiotics available for sale from drug controllers in the state.
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Published: 05 Jun 2024, 20:10 IST
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