Blue Cross responds to IPC alert on mefenamic acid in Meftal brands

Drugmaker Blue Cross Laboratories, the maker of Meftal and Meftal Spas brands, has clarified the recent alert issued by the Indian Pharmacopeia Commission (IPC) on mefenamic acid, a molecule present in both its drugs.

The brands that are trusted by doctors in India for the treatment of pain, fever, and spasm, the company said, adding that both products contained mefenamic acid as an active ingredient.

“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 company said.

“Mefenamic acid, apart from India (as Meftal and Meftal-Spas), is being prescribed in countries like USA, UK, Japan, etc., for more than four decades with billions of doses administered and has benefitted millions of patients,” it added.

“The adverse effect mentioned by the IPC, i.e., DRESS syndrome, 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,” they added.

The Pharmacovigilance Programme of India (PVPI) operates under the purview of IPC and the Health Ministry to collect data on adverse events of all drugs. It works in the interest of patients to ensure the safety and efficacy of all drugs for all disease conditions, and the company has a strong pharmacovigilance system internally and supports the efforts of PVPI, it added.

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