Painkiller Meftal can have adverse reactions, government issues alert

Dec 11,2023

The Indian Pharmacopoeia Commission (IPC) issued a drug safety alert about Meftal painkiller, stating that its constituent, mefenamic acid, can cause adverse reactions, including drug reactions with eosinophilia and systemic symptoms (DRESS) syndrome.

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

The commission, in its alert, said that a preliminary analysis of adverse drug reactions from the Pharmacovigilance Programme of India (PvPI) database revealed DRESS syndrome. DRESS syndrome is a severe allergic reaction caused by certain medicines. Its symptoms include skin rash, fever and lymphadenopathy, which can occur between two and eight weeks after taking the drug.

"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 a reaction is encountered, 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 number 1800-180-3024," the release stated.

Blue Cross Laboratories, which manufactures Meftal and Meftal-Spas, issued a clarification on the alert issued by the Indian Pharmacopeia Commission (IPC) on mefenamic acid.

“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,” it said.

“Mefenamic acid, apart from India (as Meftal and Meftal-Spas) is being prescribed in countries like the USA, the UK, Japan, etc for more than four decades with billions of doses administered and has benefitted millions of patients,” the statement said.

The firm said that 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,” Blue Cross Laboratories said.

Source: Indiatoday