Drug Safety Alert: Indian Pharmacopoeia Commission Flags Adverse Reactions Linked To Colistimethate Sodium
New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of July, has revealed that Colistimethate Sodium, an antibiotic indicated for the treatment of infections caused by susceptible strains of certain gram-negative bacilli is linked with adverse drug reactions (ADRs) named Bartter's like Syndrome.
This came after a preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.
Colistimethate is an antibiotic indicated for the treatment of infections caused by susceptible strains of certain gram-negative bacilli. It is particularly useful for targeting sensitive strains of Pseudomonas aeruginosa.
Colistimethate Sodium is indicated for the treatment of some serious infections caused by Gram-negative bacteria, including those of the lower respiratory tract and urinary tract, when more commonly used systemic antibacterial agents may be contraindicated or may be ineffective because of bacterial resistance.
Following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, it is reported that Colistimethate Sodium can lead to Bartter's like Syndrome.
Bartter-like syndrome (BLS) is a constellation of biochemical abnormalities which include metabolic alkalosis, hypokalemia, hypocalcemia, hypomagnesemia with normal kidney function. BLS is a very rare syndrome and can be induced by certain diseases, antibiotics, diuretics, and antineoplastic drugs.
Now, as per the issued drug safety alert, the following suspected drug is associated with the ADRs as given below:
Sl. No | Suspected Drugs | Indication | Adverse Drug Reaction |
1 | Colistimethate Sodium | For the treatment of some serious infections caused by Gram-negative bacteria, including those of the lower respiratory tract and urinary tract, when more commonly used systemic antibacterial agents may be contraindicated or may be ineffective because of bacterial resistance. | Bartter's like Syndrome |
In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, has advised Healthcare Professionals, Patients/Consumers to closely monitor the possibility of the above 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 of 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)."
