Health ministry body IPC issues alert against reactions of mefenamic acid

The mefenamic acid present as active ingrediant in several over-the-counter medicines

The Indian Pharmacopoeia Commission (IPC) has issued a drug safety alert advising healthcare professionals and patients to monitor adverse reactions of mefenamic acid, a molecule present in Meftal and Meftal Spas, commonly used for menstrual cramps and rheumatoid arthritis.

The mefenamic acid painkiller is prescribed in the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhoea, mild to moderate pain, inflammation, fever and dental pain.

The commission, in its alert, stated that a preliminary analysis of adverse drug reactions from the Pharmacovigilance Programme of India (PvPI) database revealed drug reactions with eosinophilia and systemic symptoms (DRESS) syndrome.

"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," according to the alert, issued on November 30.

If such reaction is encountered, the alert advised, people should report the matter to the national coordination centre of the PvPI under the commission by filing a form on the website - www.ipc.gov.in - or through android mobile app ADR PvPI and PvPI Helpline No. 1800-180-3024.

An autonomous institution of the Ministry of Health, the IPC sets standards for all drugs that are manufactured, sold and consumed in India.

Blue Cross Laboratories that makes Meftal and Meftal-Spas, said in a statement, "The alert issued by IPC was to advise Doctors and patients to monitor the possibility of an adverse drug reaction 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.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 adverse reaction 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 adverse reaction."