Blue Cross Laboratories, the pharmaceutical company behind the Meftal and Meftal Spas brands, has issued a clarification regarding the recent safety alert by the Indian Pharmacopeia Commission (IPC) concerning mefenamic acid, a key component in both medications.
According to the company, Meftal and Meftal-Spas are trusted brands recommended by doctors in India for addressing pain, fever and spasms. Both products contain mefenamic acid as an active ingredient.
In response to the IPC alert, Blue Cross Laboratories emphasised that the commission’s advisory aimed to encourage doctors and patients to monitor the potential occurrence of an adverse drug reaction (ADR) related to mefenamic acid.
However, the company stressed that this alert does not compromise the safety, effectiveness, or high quality of the established brands, which are backed by clinical studies and real-world evidence.
“We wish to issue a clarification regarding the recent media coverage of the alert issued by the Indian Pharmacopeia Commission (IPC) on mefenamic acid. 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,” reads the company’s statement.
The company pointed out that mefenamic acid, under the names Meftal and Meftal-Spas, has been prescribed in countries such as the USA, UK, Japan, and others for over four decades. With billions of doses administered, the medication has benefitted millions of patients worldwide.
Regarding the specific adverse effect mentioned by the IPC – DRESS syndrome – the company highlighted that this is an extremely rare disease. Blue Cross Laboratories noted that DRESS syndrome, also known as ADR, is associated with various drugs, including widely used ones like paracetamol and ibuprofen.
“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 statement reads.
Blue Cross Laboratories also highlighted its strong internal pharmacovigilance system and expressed support for the efforts of the Pharmacovigilance Programme of India (PVPI), operating under the IPC and the Health Ministry.
“The Pharmacovigilance Programme of India (PVPI) operates under the purview of IPC and the Ministry of Health and Family Welfare 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. Blue Cross Laboratories as a responsible company has a strong pharmacovigilance system internally and supports the efforts of PvPI,” reads the statement.
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