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 the immunosuppressive medicine tacrolimus is associated with an adverse event known as gingival hypertrophy.
This came to light after the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database.
Tacrolimus is mainly used to reduce the activity of the patient’s immune system after an organ transplant to prevent organ rejection.
It is also used in topical preparation in the treatment of severe atopic dermatitis, severe refractory uveitis after bone marrow transplants, and the skin condition vitiligo.
It was discovered in 1984 from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis.
Tacrolimus is chemically known as a macrolide. It reduces peptidyl-prolyl isomerase activity by binding to the immunophilin FKBP-12 (FK506 binding protein) creating a new complex.
This FKBP12-FK506 complex inhibits calcineurin which inhibits T-lymphocyte signal transduction and IL-2 transcription.
Also read: Safety alerts issued by IPC
Tacrolimus is indicated for prophylaxis of transplant rejection in liver, pancreas, lung, heart and kidney allograft recipients and treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.
As per a drug safety alert issued by IPC in the last week of July 2022, tacrolimus is linked with gingival hypertrophy or hyperplasia, a condition that refers to an overgrowth of gum tissue around the teeth.
Healthcare professionals and patients have been advised to closely monitor the possibility of the above ADR associated with the use of tacrolimus.
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 antifungal medicine itraconazole was associated with an adverse event known as Symmetrical Drug-Related Intertriginous and Flexural Exanthema (STRIFE).
Besides this, it also revealed 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 drugs, 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 linking the drug and the ADR event through a robust system of causality assessment.
The PvPI’s basic objective is to create a nationwide system for patient safety by ensuring adverse event reporting, identification of new adverse drug reactions, analysis of the benefit-risk ratio of the marketed drugs, and the generation of evidence-based information on the safety of drugs.
The NCC-PvPI, IPC is in the developing phase of indigenous database-Adverse Drug Reaction Monitoring Software (ADRMS) for the processing of Individual Case Safety Reports (ICSR).
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