Drug Safety Alert: IPC flags adverse reactions linked to rheumatoid arthritis drug Piroxicam
New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of September ,has revealed that Piroxicam, a non-steroidal anti-inflammatory agent (NSAID) which is used to treat the symptoms of osteoarthritis and rheumatoid arthritis, is linked with Adverse Drug Reactions (ADRs) named Fixed Drug Eruption.
This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.
Piroxicam is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Piroxicam works by reducing hormones that cause inflammation and pain in the body. Piroxicam is used to reduce the pain, inflammation, and stiffness caused by rheumatoid arthritis and osteoarthritis.
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 into the disruption of 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.
Furthermore, Piroxicam is indicated in the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, cervical spondylitis and other musculoskeletal disorder. It is an anti inflammatory agent used used in the treatment of rheumatoid arthritis, ankylosing spondylitis and other musculoskeletal disorders. In addition, it is indicated in the treatment of musculoskeletal disorders, acute gout, pain after operative intervention following acute trauma and in primary dysmenorrhoea (12 years age or older).
Following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, it is reported that Piroxicam can lead to Fixed Drug Eruption.
A fixed-drug eruption (FDE) is an immunological cutaneous adverse reaction characterized by sharply defined lichenoid lesion/s which occur/s at the same location every time there is exposure to the causative substance. Fixed-drug eruption is known to occur more frequently with antimicrobials and nonsteroidal anti-inflammatory drugs than with other drugs.
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 Reaction |
1. | Piroxicam | 1. In the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, cervical spondylitis and other musculoskeletal disorder. 2. Anti-inflammatory agent- Indicated in the treatment of rheumatoid arthritis, ankylosing spondylitis and other musculoskeletal disorders. 3. Indicated in the treatment of musculoskeletal disorders, acute gout, pain after operative intervention following acute trauma and in primary dysmenorrhoea (12 years age or older) | Fixed Drug Eruption |
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)."
