Drug Safety Alert: IPC flags adverse reactions linked to Diclofenac
New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of November, has revealed that Diclofenac is associated with Adverse Drug Reactions (ADRs) named Skin hyperpigmentation.
This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.
Diclofenac is a phenylacetic acid derivative and non-steroidal anti-inflammatory drug (NSAID). Label NSAIDs inhibit cyclooxygenase (COX)-1 and-2 which are the enzyme responsible for producing prostaglandins (PGs). PGs contribute to inflammation and pain signalling. Diclofenac, like other NSAIDs, is often used as first line therapy for acute and chronic pain and inflammation from a variety of causes.
Diclofenac is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout, painful post-operative pain following dental surgery, migraine attack and postoperative inflammation in patients who have undergone cataract operation.
Following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, it is reported that Diclofenac can lead to Adverse Drug Reactions (ADRs) known as Skin hyperpigmentation.
Now, as per the issued drug safety alert, the following suspected drug is associated with the ADRs as given below:
To view the official notice, click the link below:
Sl. No. | Suspected Drug | Indication | Adverse Drug Reaction |
1. | Diclofenac | For the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout, painful post-operative pain following dental surgery, migraine attack and post- operative inflammation in patients who have undergone cataract operation. | Skin hyperpigmentation |
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)."
