Next time you develop knee pain, menstrual cramps or dental aches, beware of buying painkillers containing mefenamic acid. The Indian Pharmacopoeia Commission (IPC) issued a drug safety alert against mefenamic acid on November 30, advising healthcare professionals and the general population to monitor adverse drug reactions (ADRs) that may be triggered by its usage.
According to the alert, “If such a reaction is encountered, people should report the matter to the national coordination centre of the Pharmacovigilance Programme of India (PvPI) under the commission by filing a form on the website – www.ipc.gov.in – or through the Android mobile app ADR PvPI and PvPI helpline number 1800-180-3024.”
Mefenamic acid is one of the easily available over-the-counter drugs in Indian pharmacies. Sold under different brand names like Meftal, Mefkind, Mefanorm and Ibuclin P, the drug is usually taken by women for menstrual cramps. In addition, it’s also used to treat rheumatoid arthritis, osteoarthritis, mild to moderate pain, inflammation, fever and toothaches.
The IPC, in its preliminary analysis of ADRs from the PvPI database, revealed that mefenamic acid can lead to drug reactions with eosinophilia and systemic symptoms (DRESS) syndrome. Also known as drug-induced hypersensitivity, DRESS syndrome refers to an allergic reaction to certain medicines, which can potentially be life-threatening. Typical symptoms like skin rash, fever and lymphadenopathy (swelling of lymph nodes) can appear two to eight weeks after taking the drug.
The alert issued by IPC states, “Healthcare professionals, patients/consumers are advised to closely monitor the possibility of the above adverse drug reactions associated with the use of the suspected drug.”
Mefenamic acid: Self-medication is a no-no
Mefenamic acid tablets are widely used as painkillers, especially by women. “Mefenamic acid is known to have side effects. As a result, we don’t prescribe it and opt for effective medicines such as paracetamol and tramadol, which are safe and have no side effects,” says Dr Vidya V Bhat, medical director of Radha Krishna Multispecialty Hospital, Bangalore.
According to her, the problem arises when people self-medicate without monitoring the usage of the drug. “As doctors, we look into an individual’s medical history and then prescribe drugs with specific dosages. But when they self-medicate, the risk of adverse side effects increases [due to improper dosage],” she says, stressing the need for strict rules to be implemented by the government that prohibit pharmacies from selling these drugs without a prescription.
Side effects of the drug are overlooked
ADRs that start to appear after two to eight weeks make it difficult to pinpoint their cause, say experts. “Most of the time, the side effects of the drug go unnoticed. As they start to manifest after two to eight weeks, people may opt for over-the-counter medicines to address these symptoms instead of consulting a doctor without realizing that these symptoms are the side effects of this drug,” explains Dr Bhat.
Usage of the drug is limited
As mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID), it’s not usually used to treat rheumatoid arthritis and osteoarthritis, says Dr Karthick Dhayalan, consultant orthopedic surgeon, Prashanth Hospital, Chennai. Speaking about its adverse effects, he shares, “It is similar to other NSAIDs that are known to have side effects. As a result, most of us avoid prescribing them.”
Meftal is typically used to treat abdominal pain, says Dr Pramod Bhor, head of the department, orthopedic surgery, Fortis Hiranandani Hospital, Vashi, Mumbai. “It’s also used among children. Most people get the drug over the counter; when its dosage is not right, it will naturally have adverse effects,” he adds.
Takeaways
- The Indian Pharmacopoeia Commission issued a drug safety alert about the use of mefenamic acid-based painkillers on November 30, 2023. It stated that the drug can cause adverse reactions, including DRESS syndrome.
- Sold as Meftal, Mefkind, Mefanorm and Ibuclin P, the drug is used to treat conditions like rheumatoid arthritis, osteoarthritis, dysmenorrhoea, mild to moderate pain, inflammation, fever and dental pain.
- According to experts, the problem arises when people self-medicate and don’t take the right dosage, giving rise to adverse reactions. As a result, they stress the need for the implementation of strict rules prohibiting pharmacies from selling these drugs without a prescription.
