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Indian Government issues safety alert over adverse reactions from Meftal; urges vigilance
The safety alert highlighted concerns about Meftal’s active ingredient called mefenamic acid, which can potentially cause an adverse reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome.
- By Pooja Chaturvedi Sah
- New Delhi
- Dec 11, 2023
The Indian Pharmacopoeia Commission (IPC) has issued an advisory regarding the side effects of the commonly used painkiller Meftal.
The safety alert highlighted concerns about Meftal’s active ingredient called mefenamic acid, which can potentially cause an adverse reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome.
DRESS syndrome, also known as drug induced hypersensitivity syndrome and by various other names, is a severe, idiosyncratic multisystem reaction to a drug, which can be potentially life-threatening.
DRESS syndrome is characterised by a combination of side effects such as skin rash, fever, inflammation of internal organs, and an increase in eosinophils, a type of white blood cell. The syndrome manifests the symptoms within 2 to 8 weeks after taking the drug.
The reaction could cause swelling of the lymph nodes, as well as internal organs such as the liver, lungs, and heart. Mefenamic acid’s adverse effects on the cardiovascular system has been pointed out in various studies throughout the years.
The IPC, in its drug safety alert on 30 November, has stated that a preliminary analysis of adverse drug reactions, sourced from the Pharmacovigilance Programme of India (PvPI) database, has identified instances of DRESS syndrome.
The Commission has urged both consumers and healthcare professionals to exercise heightened vigilance concerning the potential adverse drug reaction (ADR) linked to Meftal.
The alert also stressed on the significance of promptly reporting any adverse reactions attributed to Meftal to the National Coordination Center of the Pharmacovigilance Programme of India (PvPI). “Individuals are encouraged to submit their reports through various channels, including the IPC website (www.ipc.gov.in), the Android mobile app ADR PvPI, or by contacting the PvPI Helpline Number at 1800-180-3024”, stated the alert.
Meftal Spas is a commonly prescribed painkiller for conditions such as menstrual cramps and rheumatoid arthritis, and can be bought over the counter, without requiring a prescription.