Drug Safety Alert: IPC flags adverse reactions linked to cephalosporin antibiotic Cefoperazone
New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of August, has revealed that a broad-spectrum cephalosporin antibiotic Cefoperazone is linked with Adverse Drug Reactions (ADRs) named Coagulopathy, a condition in which the blood's ability to coagulate (form clots) is impaired..
This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.
Cefoperazone is a broad-spectrum cephalosporin antibiotic used for the treatment of bacterial infections in various locations, including the respiratory tract, abdomen, skin, and female genital tracts.
Cefoperazone is a third generation cephalosporin antibiotic. Cefoperazone exerts its bactericidal effect by inhibiting the bacterial cell wall synthesis. It binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins.
Following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, it is reported that Cefoperazone can lead to Coagulopathy.
Coagulopathy is a condition in which the blood's ability to coagulate is impaired. This condition can cause a tendency toward prolonged or excessive bleeding (bleeding diathesis), which may occur spontaneously or following an injury or medical and dental procedures.
Coagulopathy may cause uncontrolled internal or external bleeding. Uncontrolled bleeding can harm joints, muscles, or internal organs and pose a life-threatening risk if left untreated. People should seek immediate medical care for serious symptoms, including heavy external bleeding, blood in the urine or stool, double vision, severe head or neck pain, repeated vomiting, difficulty walking, convulsions, or seizures. They should seek prompt medical care if they experience mild but unstoppable external bleeding or joint swelling and stiffness.
Now, as per the issued drug safety alert, the following suspected drug is associated with the ADRs as given below:
Sl. No. | Suspected Drug | Indication | Adverse Drug Reaction |
1. | Cefoperazone | Urinary infections, biliary infections, respiratory infections, infections of skin tissues, meningitis, septicaemia, Pseudomonas, Salmonella typhi & B. fragilis infections. | Coagulopathy |
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 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)."
Also Read:Drug Safety Alert: IPC flags adverse reactions linked to cephalosporin antibiotic Cefuroxime
