The mefenamic acid painkiller is prescribed for the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhoea, pain, inflammation, and fever.
Published Dec 09, 2023 | 8:00 AM ⚊ Updated Dec 18, 2023 | 7:18 PM
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The Indian Pharmacopoeia Commission (IPC) has issued a drug-safety alert for healthcare professionals and patients to monitor the adverse reactions of mefenamic acid, a chemical that is commonly in medication used for the treatment of menstrual cramps and rheumatoid arthritis.
The mefenamic acid painkiller is prescribed for the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhoea, mild to moderate pain, inflammation, fever, and dental pain.
Although the drug is not available over the counter and requires a prescription for purchase, it is extensively utilised by individuals in India for various purposes such as alleviating menstrual pains, controlling fever in children, and headaches, as well as muscle and joint pain.
An autonomous institution of the Ministry of Health, the IPC sets standards for all drugs that are manufactured, sold, and consumed in India.
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.
“The IPC has advised healthcare professionals, patients/consumers to closely monitor the possibility of the above adverse drug reaction (ADR) associated with the use of the suspected drug,” stated the alert, issued on 30 November.
“If such a reaction is encountered, people should report the matter to the national coordination centre of the PvPI under the commission by filling a form on the website — www.ipc.gov.in — or through the Android mobile app ADR PvPI, as well as PvPI helpline number 1800-180-3024,” the alert further stated.
However, doctors South First spoke to stated that they have not observed any of the side effects mentioned by the IPC, and the usage is typically carefully regulated among patients.
“Every medicine comes with certain side effects — some serious and some not so serious. Mefenamic acid is a painkiller, prescribed by a doctor after knowing the history of the patient and any known drug allergy. I have not come across any patient who has experienced DRESS syndrome,” Dr Haripriya Vedantham, Consultant Obstetrician and Gynaecologist at Yashoda Hospitals in Hyderabad, told South First.
She added that, despite this, the medicine is a secondary choice in her practice. “When a woman presents with menstrual pain, the initial preference is to prescribe Dicyclomine + Paracetamol, which effectively alleviates abdominal pain. In the event of allergies or ineffectiveness of the prescribed medication, the alternative choice is to recommend mefenamic acid,” she said.
The primary issue lies in the unchecked and excessive usage of the drug. Despite being a prescription medication, mefenamic acid is extensively employed in India for diverse purposes, with its use even prevalent among children to address high fever.
“For parents, particularly when managing fever, it is advisable to prioritise the use of paracetamol whenever possible. Administer it judiciously, ensuring the correct dosage and maintaining appropriate intervals. If fever persists despite paracetamol, consider using ibuprofen cautiously after consulting with your child’s doctor and adhering to the prescribed dosage,” advised Hyderabad-based paediatrician Dr Sivaranjani Santosh.
She added that it’s crucial to be aware that ibuprofen, mefenamic acid, and similar medications can have adverse effects such as platelet suppression, leading to issues like stomach bleeding and gastritis.
“Overuse may also impact the kidneys. In the case of mefenamic acid, available as Meftal, excessive use can elevate the risk of seizures. Always strike a balance between the potential risks and benefits, using these medicines extremely judiciously and under professional guidance,” Dr Sivaranjani advised.
Senior Consultant and Head of the Department of Paediatrics and Neonatology at Sakra World Hospital in Bengaluru, Dr Rajath Athreya explained that fever is the body’s response to an infection. In children, it is most commonly due to viral infections. Rarely, fevers have a non-infectious inflammatory cause.
Speaking to South First, he said, “The safest medicine to use to treat fevers in children is paracetamol. This has to be used in the right dose (15mg/kg body weight per dose up to a maximum of 4 times in 24 hours, an adult should never exceed 4 g in a day). Apart from paracetamol, we have a good safety record worldwide with the use of ibuprofen. This is for occasional use, especially if there is need for pain relief, or an add-on medicine when fevers are recurring within a few hours.”
Speaking about the use of Meftal syrup for children, Dr Athreya said, “The approved indication for this drug is period pains and joint pains. Although it brings down fever rapidly, this drug does not feature in any standard international guidelines of managing fever in children. As it brings down fever more rapidly than paracetamol, in India it has become popular amongst prescribers and parents.”
“There is no valid published safety data in children for repeated use for fevers in kids. Unlike in India, it is never used to treat fevers in kids in the west. I am wary of lack of safety data. However, it is a common prescription and many practitioners in India say they have not seen any severe adverse reactions,” said Dr Athreya.
A major issue that has been found by doctors who do prescribe mefenamic acid is that it causes gastrointestinal issues.
“The challenge extends to all nonsteroidal anti-inflammatory drugs (NSAIDs). When a patient presents with gastritis, the recommendation is to take these medications with food, and in some cases, additional medication for gastritis may be prescribed. Prolonged usage of drugs like Meftal raises the risk of developing stomach ulcers, bleeding, and associated complications,” said Dr Haripriya.
She added, “Individuals with a history of gastrointestinal issues or those concurrently using other NSAIDs should exercise caution when considering these medications.”
Furthermore, mefenamic acid has been linked to potential adverse effects on the cardiovascular system. Certain studies indicate a correlation between the use of NSAIDs, including mefenamic acid, and an elevated risk of cardiovascular events, especially in individuals with pre-existing heart conditions.
Additionally, experts have raised concerns about renal complications as a potential side effect of Meftal.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is a severe and potentially life-threatening hypersensitivity reaction to certain medications. It is a rare but serious condition characterised by a combination of skin rash, fever, inflammation of internal organs, and haematologic abnormalities.
Key features of DRESS syndrome include:
The exact cause of DRESS is not fully understood, but it is thought to be an immune-mediated reaction to certain drugs. Various medications have been associated with DRESS, including antiepileptic drugs, allopurinol, sulfonamides, and certain antibiotics.
It’s crucial to recognise DRESS early, as the condition can progress rapidly and lead to severe complications. Treatment typically involves discontinuing the culprit medication and providing supportive care. In some cases, corticosteroids or other immunosuppressive medications may be prescribed to help manage the inflammatory response.
If you suspect DRESS or experience symptoms after taking a medication, it is important to seek medical attention promptly. DRESS is a medical emergency, and early recognition and intervention are essential for a better prognosis. Always consult with healthcare professionals for accurate diagnosis and appropriate management.
