Drug Safety Alert: Indian Pharmacopoeia Commission Flags Adverse Reactions Linked To Amphotericin B
New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of January, has revealed that Amphotericin B (Liposomal), popular antifungal drug, is linked with Adverse Drug Reactions (ADRs) named Hearing disorders and Tachycardia.
This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.
Amphotericin B is an antifungal used to treat fungal infections in neutropenic patients, cryptococcal meningitis in HIV infection, fungal infections, and leishmaniasis.
In accordance with the notification, Amphotericin B is indicated for the treatment of Febrile Neutropenia in cancer patients. Furthermore, it is indicated for invasive fungal infection in patients who are refractory to or intolerant of conventional amphotericin B therapy.
In addition, Amphotericin B is indicated for the treatment of visceral leishmaniasis.
Amphotericin B is fungistatic or fungicidal depending on the concentration obtained in body fluids and the susceptibility of the fungus. The drug acts by binding to sterols (ergosterol) in the cell membrane of susceptible fungi. This creates a transmembrane channel, and the resultant change in membrane permeability allowing leakage of intracellular components. Ergosterol, the principal sterol in the fungal cytoplasmic membrane, is the target site of action of amphotericin B and the azoles. Amphotericin B, a polyene, binds irreversibly to ergosterol, resulting in disruption of membrane integrity and ultimately cell death.
Following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, it is reported that Amphotericin B can lead to Hearing disorders and Tachycardia. Tachycardia is a condition that makes heart beat more than 100 times per minute.
Now, as per the issued drug safety alert, the following suspected drug is associated with the ADRs as given below:
Sl.No. | Suspected Drug | Indications | Adverse Drug Reactions |
1 | Amphotericin B (Liposomal) | 1. Febrile Neutropenia in cancer patients. 2. For invasive fungal infection in patients who are refractory to or intolerant of conventional amphotericin B therapy. 3. By RMP- for the treatment of invasive fungal infection in patients who are refractory to or intolerant of conventional amphotericin-B therapy. 4. Indicated for the treatment of visceral leishmaniasis | Hearing disorders |
2 | Tachycardia |
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)."
