Drug Safety Alert: Indian Pharmacopoeia Commission Flags ADR Linked To Meropenem
New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of May, has revealed that the carbapenem antibiotic Meropenem is linked with adverse drug reactions (ADRs) named Acute Generalized Exanthematous Pustulosis (AGEP).
In connection with the above, the Indian Pharmacopoeia Commission (IPC) has cautioned healthcare professionals to diligently monitor the potential occurrence of adverse drug reactions (ADRs) when administering Meropenem.
This came after a preliminary analysis of adverse drug reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.
Meropenem is a carbapenem antibiotic used to treat a wide variety of infections in the body. The bactericidal activity of meropenem results from the inhibition of cell wall synthesis. Meropenem readily penetrates the cell walls of most Gram-positive and Gram-negative bacteria to reach penicillin-binding protein (PBP) targets.
The alert noted that Meropenem is indicated for the treatment of pneumonia, nosocomial pneumonia, UTI, intraabdominal infection, gynaecological infection, skin and soft tissue infection, meningitis, septicaemia, and empiric treatment of presumed infection in adult patients with febrile neutropenia.
Following the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database, it is reported that meropenem can lead to acute generalized exanthematous pustulosis (AGEP).
Acute generalized exanthematous pustulosis (AGEP) represents a severe, usually drug-related skin reaction characterized by acute formation of sterile pustules on an erythematous background, fever, and neutrophilia. AGEP is usually classified as a severe cutaneous adverse reaction (SCAR) to a prescribed drug. It is also called toxic pustuloderma.
Now, as per the issued drug safety alert, the following suspected drug is associated with the ADR as given below:
S. No | Suspected Drug | Indication | Adverse Drug Reaction |
1 | Meropenem | For the treatment of pneumonia, nosocomial pneumonia, UTI, intraabdominal infection, gynaecological infection, skin and soft tissue infection, meningitis, septicaemia, and empiric treatment of presumed infection in adult patients with febrile neutropenia. | Acute Generalized Exanthematous Pustulosis (AGEP) |
In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, has advised healthcare professionals, patients, and consumers to closely monitor the possibility of the ADRs associated with the use of the above-suspected drugs.
Further, the safety alert added, "If such reaction is encountered, please report to the NCC-PvPI, IPC by filling out Suspected Adverse Drug Reactions Reporting Form/Medicines Side Effect Reporting Form for Consumer (http://www.ipc.gov.in), through Android Mobile App "ADR PvPI App" and PvPIHelpline No. 1800-180-3024 (Toll-Free)."
To view the official notice, click the link below:
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