It said its constituent, mefenamic acid, can cause adverse reactions, including drug reactions with eosinophilia and systemic symptoms (DRESS) syndrome.
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, it advised healthcare professionals, patients and consumers to closely monitor the possibility of the above adverse drug reactions (ADR) associated with the use of the above suspected 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 www.ipc.gov.in or through android mobile app ADR PvPI and PvPI Helpline no. 1800-180-3024, it said.
