Those who rely on Meftal spas to alleviate pain, menstrual cramps or rheumatoid arthritis then this news is for you. The Indian Pharmacopoeia Commission (IPC) has issued a drug safety alert, categorically highlighting concerns about Meftal's active ingredient, mefenamic acid. According to the alert, the use of mefenamic acid in Meftal can lead to potential adverse reactions, causing eosinophilia and systemic symptoms (DRESS) syndrome.
What is DRESS Syndrome?
DRESS syndrome stands for Drug Reaction with Eosinophilia and Systemic Symptoms. It is a severe and potentially life-threatening hypersensitivity reaction to certain medications. This syndrome is characterised by a combination of skin rash, fever, inflammation of internal organs, and an increase in eosinophils, a type of white blood cell.
Key features of DRESS syndrome include:
- Skin Rash: The syndrome often begins with a widespread rash that can be itchy and red. The rash may start on the face and then spread to other parts of the body.
- Fever: Individuals with DRESS syndrome typically experience a high fever.
- Swelling: There may be swelling of the lymph nodes, as well as internal organs such as the liver, lungs, and heart.
- Organ Involvement: DRESS syndrome can affect multiple organs, leading to symptoms such as hepatitis (inflammation of the liver), pneumonitis (inflammation of the lungs), and myocarditis (inflammation of the heart).
- Eosinophilia: An increase in eosinophils in the blood is a common feature. Eosinophils are a type of white blood cell involved in the immune response.
What Does The Govt Say in Its Alert?
"Healthcare professionals, patients/consumers are advised to closely monitor the possibility of the above adverse drug reaction (ADR) associated with the use of the suspected drug," an alert stated.
The alert also underlined 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.
Blue Cross Laboratories makes Meftal and Meftal-Spas issues clarification
The alert issued by IPC was to advise Doctors and patients to monitor the possibility of an adverse drug reaction (ADR) of mefenamic acid, which does not in any way impact the safety, efficacy and high quality of the brands that are established and supported by clinical studies and real-world evidence.
Mefenamic acid, apart from India (as Meftal and Meftal-Spas) has been prescribed in countries like the USA, UK, Japan, etc for more than four decades with billions of doses administered and has benefitted millions of patients.
The ADR i.e. DRESS syndrome, mentioned in the IPC alert, is a very rare event that is previously documented in the medical literature, both in India and globally. It is a known ADR of many drugs and published reports are available for paracetamol and ibuprofen. When prescribing any medicine, doctors take patient history and other individual factors into account to reduce the risk of any ADR.