The Indian Pharmacopoeia Commission (IPC), a federal government body, has found possible side effects of meropenem, a widely used life-saving antibiotic manufactured by major pharmaceutical companies such as Pfizer, and has advised doctors and patients to exercise caution while using the drug.
The Union Ministry of Health and Family Welfare has stated that use of meropenem may cause side effects in patients in the form of acute generalized exanthematous pustular disease (AGEP), a severe drug-related reaction, which may be life-threatening.
This medicine is primarily prescribed by doctors to treat pneumonia, urinary tract infections, intra-abdominal infections, skin infections, meningitis, sepsis, gynecological infections etc.
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Meropenem drugs are sold under various brand names in India. The drug falls under Schedules H and H1 of the Drugs and Cosmetics Rules, 1945, which mandates retail sale only on the basis of a doctor’s prescription.
“Analysis of adverse drug reactions from the Pharmacovigilance Programme of India (PvPI) database reveals that meropenem drugs cause adverse drug reactions,” the IPC drug safety alert said. mint.
“We will closely monitor the situation.”
“Healthcare professionals, patients and consumers are advised to closely monitor for possible ADRs mentioned above associated with the use of the above suspected drugs and report any such reactions to the IPC,” the ministry said.
“Pfizer’s meropenem product label already contains a safety warning for acute generalized exanthematous pustulosis (AGEP). Patient safety is our top priority and we are committed to working with authorities to deliver high-quality products that meet the highest standards of safety and effectiveness,” a Pfizer spokesperson said.
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“Any reports of adverse reactions due to drug use must be reported to the government,” said one state drug controller, who spoke on condition of anonymity.
The IPC monitors adverse drug reactions among the Indian population and assists the Central Drugs Standard Control Organisation (CDSCO) in taking regulatory decisions regarding the safe use of medicines.
Meanwhile, in a bid to curb the overuse of antibiotics, India’s regulator, Drugs Controller General, has directed state and union territory governments to closely monitor and immediately ban the sale of inappropriate antibiotic combinations currently on the market. It has also instructed officials to ensure that such combinations are not distributed in the market.
The regulator has asked state drug control authorities to submit detailed reports of all approved antibiotics available for sale.
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