Government Sounds Alarm on Adverse Effects of Popular Painkiller Meftal

On November 30, the IPC (Indian Pharmacopoeia Commission) issued a drug safety alert, urging both consumers and healthcare professionals to closely monitor the potential occurrence of adverse drug reactions (ADRs) associated with the painkiller Meftal. Meftal is commonly prescribed for the treatment of conditions such as rheumatoid arthritis, osteoarthritis, dysmenorrhoea, mild to moderate pain, inflammation, fever, and dental pain. The commission's alert was prompted by a preliminary analysis of adverse drug reactions recorded in the PvPI (Pharmacovigilance Programme of India) database, which revealed incidents of DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) syndrome.

DRESS syndrome presents an uncommon yet serious risk, potentially evolving into a life-threatening complication induced by medications such as Meftal. This syndrome manifests through a combination of severe symptoms, including a troublesome skin rash, elevated body temperature, enlarged lymph nodes, and involvement of internal organs such as the liver, kidney, and heart. The occurrence of DRESS syndrome usually occurs within 2 to 8 weeks after starting the medication.

Blue Cross Laboratories, the pharmaceutical company behind the Meftal and Meftal Spas brands, has provided clarification regarding the recent alert issued by the Indian Pharmacopoeia Commission (IPC) concerning mefenamic acid, a key component in both medications. The company emphasized that the adverse effect highlighted by the IPC, specifically DRESS syndrome, is an exceedingly rare occurrence documented in medical literature, both in India and globally. This adverse drug reaction (ADR) is well-known and has been reported in association with various drugs, including paracetamol and ibuprofen, with published reports available. It was noted that when prescribing any medication, healthcare professionals consider patient history and other individual factors to minimize the risk of any adverse drug reactions.

Meftal, classified as a NSAID (non-steroidal anti-inflammatory drug), is readily available without a prescription, making it easily accessible over the counter. This unrestricted availability frequently results in its usage without medical oversight. Nevertheless, it is expected that the recent significant disclosure may result in a reduction in Meftal consumption, subsequently increasing the demand for alternative painkillers like Aspirin in the coming months, potentially leading to a surge in prices.

Beyond Meftal, numerous medications are prohibited in India, yet their demand persists due to a lack of awareness. Some of these banned drugs include combinations used for treating common ailments like cough and fever, such as nimesulide + paracetamol dispersible tablets, chlorpheniramine maleate + codeine syrup, and pholcodine + promethazine.

Earlier on December 4th, tests conducted in India on a cough syrup associated with the deaths of at least six children in Cameroon revealed undisclosed quality concerns in at least one of the five samples collected by authorities.

A robust drug regulation system is crucial for India, as it not only ensures the supply of high-quality drugs to its domestic population but also plays a significant role in meeting 20 percent of the global demand. Additionally, it is imperative to raise awareness about adverse drug reactions and encourage both individuals and healthcare professionals to report any such incidents. This proactive reporting can help prevent potential safety issues associated with specific drugs available in the market.