Last Updated on December 26, 2023 by The Health Master
The Indian Pharmacopoeia Commission (IPC), which is the National Coordination Centre (NCC) for the Pharmacovigilance Programme of India (PvPI), has flagged a drug safety alert revealing that cefoperazone, a third-generation cephalosporin antibiotic, is associated with an adverse event known as coagulopathy, a bleeding disorder.
This came to light after the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database.
Cefoperazone is a new beta-lactam antibiotic that possesses a broad spectrum of activity against gram-positive and gram-negative organisms.
It is used to target bacteria responsible for causing infections of the respiratory and urinary tract, skin, and female genital tract.
It is one of few cephalosporin antibiotics effective in treating Pseudomonas bacterial infections which are otherwise resistant to these antibiotics.
It was patented in 1974 and approved for medical use in 1981.
Cefoperazone exerts its bactericidal effect by inhibiting bacterial cell wall synthesis, and sulbactam acts as a beta-lactamase inhibitor, to increase the antibacterial activity of cefoperazone against beta-lactamase-producing organisms.
While its clinical use has been discontinued in the US, cefoperazone is available in European countries, Latin American countries, Australia, and India among others.
As per the drug safety alert issued by IPC last week of August, cefoperazone is linked with coagulopathy, a condition in which the blood’s ability to coagulate (form clots) is impaired.
Coagulopathy may cause uncontrolled internal or external bleeding. Left untreated, uncontrolled bleeding may cause damage to joints, muscles, or internal organs and may be life-threatening.
Healthcare professionals and patients have been advised to closely monitor the possibility of the above ADR associated with the use of cefoperazone. If such a reaction is encountered, it needs to be reported to the NCC-PvPI for suitable action.
IPC had earlier also flagged drug safety alerts revealing that immunosuppressive medicine tacrolimus was associated with an adverse event known as gingival hypertrophy while antifungal medicine itraconazole was linked with Symmetrical Drug-Related Intertriginous and Flexural Exanthema (SDRIFE).
Besides this, it also cautioned that second-generation cephalosporin antibiotic, cefuroxime was associated with drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome while beta-lactam antimicrobials, cephalosporins, and anti-inflammatory drug, ibuprofen were associated with an adverse event known as fixed drug eruption.
PvPI was implemented by the CDSCO in July 2010 across the country.
Since then, IPC has been mandated to establish clinical evidence between the drug and the ADR event through a robust system of causality assessment.
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