Meftal, a painkiller popularly used to treat menstrual cramps, has come under the radar as the Indian Pharmacopoeia Commission (IPC) has issued a drug safety alert for Mefenamic acid. The IPC has urged consumers and healthcare professionals to remain vigilant regarding potential adverse drug reactions (ADRs) linked to the drug.
Commonly used to alleviate menstrual cramps and rheumatoid arthritis, Meftal's main composition is Mefenamic acid.
Meanwhile, Blue Cross Laboratories makes Meftal and Meftal-Spas has issued a statement stating "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.
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,"
The alert stems from a preliminary analysis of adverse drug reactions reported in the Pharmacovigilance Programme of India (PvPI) database, revealing instances of Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome.
The alert emphasises the importance of reporting any adverse reactions due to Meftal to the national coordination centre of the PvPI. Individuals can submit reports through the IPC website (www.ipc.gov.in), the Android mobile app ADR PvPI, or the PvPI Helpline Number 1800-180-3024.
What is DRESS Syndrome
DRESS syndrome, a severe allergic reaction affecting approximately 10% of individuals, poses potential life-threatening risks and is associated with specific medications. It comes as fever, skin rash, lymphadenopathy, haematological abnormalities, and internal organ involvement, typically surfacing two to eight weeks after the drug has been taken.
Vigilance in monitoring medication usage is crucial to prevent this severe reaction.
Apart from the potential association with DRESS syndrome, Mefenamic acid has also been linked to adverse effects on the cardiovascular system.
Studies suggest a correlation between the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including mefenamic acid, and an increased risk of cardiovascular events, particularly in individuals with pre-existing heart conditions.
Additionally, renal complications have been flagged as a potential side effect of Mefenamic acid, prompting a comprehensive evaluation of its safety profile.
Meftal Spas, a combination drug containing mefenamic acid and dicyclomine, holds substantial importance as one of India's widely used painkillers.
Primarily employed for alleviating menstrual symptoms such as abdominal pain, bloating, and gastric issues, it is occasionally prescribed for mild to moderate pain and inflammation.
Meftal Spas is a non-steroidal anti-inflammatory drug (NSAID) and is easily accessible over the counter, without requiring a prescription. This accessibility often leads to its consumption without medical supervision.
(Edited by : Amrita)
First Published: Dec 8, 2023 9:23 AM IST
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