Drug Safety Alert: IPC flags adverse reactions linked to Ibuprofen

New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of January, has revealed that Ibuprofen is associated 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.

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) derived from propionic acid and it is considered the first of the propionics. It it is a non-selective inhibitor of cyclooxygenase, which is an enzyme involved in prostaglandin (mediators of pain and fever) and thromboxane (stimulators of blood clotting) synthesis via the arachidonic acid pathway. Ibuprofen is very common over the counter medication widely used as an analgesic, anti-inflammatory and antipyretic. It is indicated for the treatment of chronic arthritic disorders and painful musculoskeletal conditions.

Following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, it is reported that Ibuprofen can lead to Adverse Drug Reactions (ADRs) known as Fixed Drug Eruption.

A fixed-drug eruption (FDE) is a unique cutaneous adverse drug effect in the form of recurrent lesions at the same site after re-exposure to the offending agent.

Now, as per the issued drug safety alert, the following suspected drug is associated with the ADRs as given below:

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 PvPI Helpline No. 1800-180-3024 (Toll Free)."

To view the official notice, click the link below: