Last Updated on October 10, 2024 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 piroxicam, a nonsteroidal anti-inflammatory drug (NSAID), is associated with an adverse event known as fixed drug eruption.
This came to light after the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database.
Piroxicam is an NSAID of the oxicam class used to treat rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, cervical spondylitis and other musculoskeletal disorder, acute got, pain after operative intervention following acute trauma and in primary dysmenorrhoea (12 years age or older).
It acts as an analgesic, especially where there is an inflammatory component.
The drug works by preventing the production of endogenous prostaglandins which are involved in the mediation of pain, stiffness, tenderness and swelling.
The anti-inflammatory effect of piroxicam may result from the reversible inhibition of cyclooxygenase, causing the peripheral inhibition of prostaglandin synthesis.
- The prostaglandins are produced by an enzyme called Cox-1.
- Piroxicam blocks the Cox-1 enzyme, resulting in the disruption of the production of prostaglandins.
- Piroxicam also inhibits the migration of leukocytes into sites of inflammation and prevents the formation of thromboxane A2, an aggregating agent, by the platelets.
As per the drug safety alert issued by IPC last week of September, piroxicam is linked with fixed drug eruption, a distinctive type of cutaneous drug reaction that characteristically recurs in the same locations upon re-exposure to the offending drug.
Acute fixed drug eruption usually presents with a single or a small number of dusky red or violaceous plaques that resolve to leave post-inflammatory hyperpigmentation.
Healthcare professionals and patients have been advised to closely monitor the possibility of the above ADR associated with the use of piroxicam.
If such a reaction is encountered, it needs to be reported to the NCC-PvPI for suitable action.
Earlier IPC had also flagged drug safety alerts revealing that beta-lactam antimicrobials, cephalosporins and anti-inflammatory drug, ibuprofen, were associated with adverse events known as fixed drug eruption.
Besides this, it also cautioned that second-generation cephalosporin antibiotic, cefuroxime was associated with drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome while immunosuppressive medicine tacrolimus was linked with an adverse event known as gingival hypertrophy.
It further revealed that the antifungal medicine itraconazole caused an adverse event known as Symmetrical Drug-Related Intertriginous and Flexural Exanthema (SDRIFE).
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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