Drug Safety Alert: IPC Identifies Hypotension as Suspected ADR Linked to Polymyxin B
New Delhi: The Indian Pharmacopoeia Commission (IPC), in its Drug Safety Alert, has flagged a safety signal indicating that the antibiotic Polymyxin B may be associated with hypotension, a condition characterised by abnormally low blood pressure.
In connection with the above, the Indian Pharmacopoeia Commission (IPC) has advised healthcare professionals and patients to closely monitor the possibility of the suspected adverse drug reaction (ADR) associated with the use of Polymyxin B.
This follows an analysis of adverse drug reaction (ADR) reports available in the Pharmacovigilance Programme of India (PvPI) database, which identified hypotension as a suspected adverse reaction associated with Polymyxin B.
Polymyxin B is an antibiotic indicated for the treatment of infections of the urinary tract, meninges and bloodstream caused by susceptible strains of Pseudomonas aeruginosa. The safety alert also states that Polymyxin B may be used as a subconjunctival injection for the treatment of eye infections caused by susceptible strains of Pseudomonas aeruginosa.
The alert further lists its use in serious infections caused by susceptible strains of other organisms, including Haemophilus influenzae specifically in meningeal infections, Escherichia coli specifically in urinary tract infections, Aerobacter aerogenes specifically in bacteremia, and Klebsiella pneumoniae specifically in bacteremia.
The safety alert noted that, based on the analysis of ADR reports from the PvPI database, Polymyxin B has been reported to be associated with hypotension.
As per the issued Drug Safety Alert, the suspected drug and its associated ADR are as follows:
S. No. | Suspected Drug | Indication(s) | Adverse Drug Reaction |
1 | Polymyxin B |
| Hypotension |
In light of the above findings, the IPC has urged healthcare professionals and patients to closely monitor for the suspected adverse reaction associated with Polymyxin B therapy.
The safety alert further stated that If such adverse reaction is encountered, it should be reported to the NCC-PvPI, IPC by filling of Suspected Adverse Drug Reactions Reporting Form by healthcare professionals , the Medicines Side Effect Reporting Form by Consumer (download from https://www.ipc.gov.in). Reports can also be submitted through the PvPI Helpline Number 1800-180-3024, PvPI Mobile App 2.0, available on the Google Play Store, and the Adverse Drug Reaction Monitoring System (ADRMS).
To view the official notice, click the link below:
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