Last Updated on October 10, 2024 by The Health Master
The Indian Pharmacopoeia Commission (IPC), which is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI), has flagged drug safety alert revealing that ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) which is used to treat pain and inflammatory diseases, is linked with adverse event known as fixed drug eruption.
This came to light after the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database.
Ibuprofen, one of the most popular over the counter medicines, is used as an analgesic, anti-inflammatory and antipyretic. It is indicated for the treatment of chronic arthritic disorders and painful musculoskeletal conditions.
Unlike most other NSAIDs, ibuprofen also acts as an inhibitor of Rho kinase and is useful in recovery from spinal-cord injury.
Ibuprofen works by inhibiting the cyclooxygenase (COX) enzymes, which convert arachidonic acid to prostaglandin H2 (PGH2). PGH2, in turn, is converted by other enzymes to several other prostaglandins (which are mediators of pain, inflammation, and fever) and to thromboxane A2 (which stimulates platelet aggregation, leading to the formation of blood clots).
As per drug safety alert issued by IPC on January 18, 2022, ibuprofen is associated 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.
Healthcare professionals and patients have been advised to closely monitor the possibility of the above ADR associated with the use of Ibuprofen.
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 Covid-19 drug remdesivir was linked to an adverse event known as sinus bradycardia.
Besides this, it had earlier also flagged drug safety alerts revealing that diclofenac, a NSAID, was linked to skin hyperpigmentation while dimethyl fumarate, used for relapsing-remitting multiple sclerosis, was associated with adverse drug reaction alopecia.
Cefazolin, a cephalosporin antibiotic, was linked to acute generalized exanthematous pustulosis (AGEP), according to the preliminary analysis of ADRs from the PvPI database.
The CDSCO had started PvPI 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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