Mefenamic acid can have adverse reactions; govt issues drug safety alert

The Indian Pharmacopoeia Commission states that mefenamic acid can cause adverse reactions, including drug reactions with eosinophilia and systemic symptoms syndrome

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

According to a report in The Economic Times (ET), the painkillers like Meftal that contains mefanamic acid is prescribed for the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhoea, mild to moderate pain, inflammation, fever, and dental pain. It is also taken to alleviate muscle and joint pain, and period pain and can also help with sore throats, nerve pain, and muscle aches.

In the alert, the IPC stated: "Healthcare professionals, patients, and consumers are advised to closely monitor the possibility of the above adverse drug reactions (ADR) associated with the use of the above-suspected drug."

It further said: "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 www.ipc.gov.in or through android mobile app ADR PvPI and PvPI Helpline no. 1800-180-3024."

Prolonged use of drugs like Meftal may increase the risk of stomach ulcers, bleeding, and adverse effects on the cardiovascular system. Some studies suggest a correlation between non-steroidal anti-inflammatory drugs (NSAIDs) use, including mefenamic acid, and an increased risk of cardiovascular events, particularly in individuals with pre-existing heart conditions.

What is DRESS syndrome?

The Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome is a severe idiosyncratic response to a medication, marked by a protracted onset period. It is mainly linked to medications such as abacavir, allopurinol, and lamotrigine.

The symptoms include fever, skin rash, lymphadenopathy, eosinophilia, and a spectrum of systemic manifestations ranging from mild to severe. The syndrome has an estimated mortality rate of 10 per cent. 

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."