Meftal painkiller: Meftal maker says adverse reaction flagged by IPC is very rare

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Blue Cross Laboratories, which owns the Meftal painkiller brand, said the adverse reaction from the use of the drug that the Indian Pharmacopoeia Commission (IPC) has flagged was a very rare event that was previously documented in medical literature, both in India and globally.

In a clarification issued days after the IPC came out with a safety alert on the drug, the company said the product’s constituent, mefenamic acid, can cause adverse reactions, including drug reactions with eosinophilia and systemic symptoms (DRESS) syndrome.

Mefenamic acid, apart from India (as Meftal and Meftal-Spas) has been prescribed in countries like the US, UK and Japan for more than four decades with billions of doses administered, benefitting millions of patients, it said.

The DRESS syndrome is a known adverse reaction of many drugs and that published reports on that are available for paracetamol and ibuprofen, the company said. When prescribing any medicine, doctors take patient history and other individual factors into account to reduce the risk of any adverse reactions, it said.

“Blue Cross Laboratories makes Meftal and Meftal-Spas, the brands that are trusted by doctors in India for the treatment of pain, fever, and spasm. They contain mefenamic acid as an active ingredient,” it said.

Blue Cross Laboratories as a responsible company has a strong pharmacovigilance system internally and supports the efforts of PvPI (Pharmacovigilance Programme in India),” the company said in a statement.The painkiller is available over the counter and is prescribed for the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhoea, mild to moderate pain, inflammation, fever and dental pain.In its alert, the IPC advised healthcare professionals, patients and consumers to closely monitor the possibility of adverse drug reactions associated with the use of the drug.

If such reaction is encountered, the alert advised, people should report the matter to the national coordination centre of the 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 No. 1800-180-3024.

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