In the backdrop of a caution by the Indian Pharmacopoeia Commission (IPC) against mefenamic acid, a major component of painkiller meftal, the medicine's manufacturer on Tuesday said the alert seeks to advise doctors and patients to monitor the possibility of an adverse reaction of the drug.
"The alert issued by IPC was to advise doctors and patients to monitor the possibility of an adverse drug reaction 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," Blue Cross Laboratories, which makes meftal and meftal-spas, said in a statement.
The IPC on November 30 had issued an alert on mefenamic acid stating that a preliminary analysis of adverse drug reactions from the Pharmacovigilance Programme of India (PvPI) database revealed drug reactions with eosinophilia and systemic symptoms (DRESS) syndrome.
"Healthcare professionals, patients/consumers are advised to closely monitor the possibility of the above adverse drug reaction (ADR) associated with the use of the suspected drug," it had stated.
If such a 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 android mobile app ADR PvPI and PvPI Helpline number 1800-180-3024.
The company said mefenamic acid, apart from India (as meftal and meftal-spas) is being prescribed in countries like the USA, the UK, Japan etc. for more than four decades with billions of doses administered and has benefitted millions of patients.
The ADR i.e. DRESS syndrome, mentioned in the IPC alert,is a very rare event that is previously documented in medical literature, both in India and globally.
"It is a known adverse reaction of many drugs…When prescribing any medicine, doctors take patient history and other individual factors into account to reduce the risk of any adverse reaction," the statement said.
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