 "meftal")
Amid alerts over possible adverse reactions due to usage of mefenamic acid, a molecule present in painkiller Meftal and Meftal Spas, doctors have called for intensifying monitoring and awareness among patients consuming the drug.
Concerns regarding painkillers using mefenamic acid as a constituent arose after the Indian Pharmacopoeia Commission (IPC), an autonomous body under the ministry of health and family welfare, issued a drug safety alert.
It advised healthcare professionals and patients on November 30 to monitor adverse reactions of mefenamic acid which is present as an active ingrediant in several over-the-counter medicines.
The commission, in its alert, stated that a preliminary analysis of adverse drug reactions from the Pharmacovigilance Programme of India (PvPI) database associated Meftal and its constituent mefenamic acid with potential development of drug reactions with eosinophilia and systemic symptoms (DRESS) syndrome.
“Healthcare professionals, patients/consumers are advised to closely monitor the possibility of adverse drug reaction associated with the use of the suspected drug,” IPC said in its alert.
Meftal is a painkiller generally available over the counter and is prescribed for diverse conditions. These include menstrual cramps and rheumatoid arthritis, mild-to-moderate pain, inflammation, fever and dental pain.
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Speaking on the issue, Rashmi Baliyan, gynaecologist and obstetrician consultant, Primus Super Speciality Hospital, said that the IPC’s issuance of a drug safety alert against reactions of the painkiller Meftal underscores the critical importance of monitoring and awareness within the medical community and among patients.
“As a nonsteroidal anti-inflammatory drug (NSAID), mefenamic acid carries its share of risks and side effects, including gastrointestinal issues, cardiovascular complications, and renal problems,” she added.
Calling DRESS syndrome symptoms rare, Aruna Kalra, senior gynaecologist and obstetrician, CK Birla Hospital, said mefenamic acid-based drugs have been time tested for decades.
“They have their side effects, but only a few patients show severe symptoms,” she added.
Manoj Sharma, senior consultant, internal medicine, Fortis Hospital, said that it is known that mefenamic acid can have severe implications to the kidney in patients using it for the long term, but it can trigger a severe allergic reaction only in rare cases.
Blue Cross Laboratories that makes Meftal and Meftal-Spas, said in a statement, "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 and real-world evidence.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 adverse reaction 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 adverse reaction."
With inputs from Sohini Das
