New Delhi: The Indian Pharmacopoeia Commission (IPC) — the apex agency for setting drug standards in India — has issued a safety alert for mefenamic acid, a common painkiller widely used for menstrual pain, moderate pain, inflammation, fever, dental pain, rheumatoid arthritis, and osteoarthritis.
The alert warns that the drug can cause a severe allergic reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome.
DRESS syndrome is a potentially fatal condition that is characterised by fever, skin rashes, enlarged lymph nodes, and internal organ damage, such as hepatitis, pericarditis, and pneumonitis.
The IPC, in the alert issued on 30 November, also advised doctors and patients to monitor the effects of the drug and report any adverse reactions to the Pharmacovigilance Programme of India (PvPI), which collects and analyses data on drug safety. ThePrint has a copy of the alert.
Mefenamic acid is sold under various brand names, such as Meftal, Mefanorm, Mefkind, Mefast, Ibuclin P, and others.
It belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which were first launched in the 1960s and became generic in the 1980s. Mefenamic acid has been used in India for decades, and is commonly prescribed for high fever in children.
As of now, the potential side-effects listed with mefenamic acid — also mentioned on its labels in some cases, like other NSAIDs — include gastrointestinal bleeding and cardiovascular events, said Dr Anusha Rao P, consultant for obstetrics and gynaecology with Yashoda Hospitals in Hyderabad.
According to medical experts, the fact that the DRESS syndrome may be associated with mefenamic acid is not completely new — even though in many cases, specific adverse reactions related to a drug are identified only after years of use.
“There is no drug which can be termed as completely safe,” said senior pharmacologist Dr Santanu K. Tripathi, who has previously been associated with several committees under the Central Drugs Standard Control Organisation, the national regulator for the sector.
“Any drug is prescribed to a patient only if a doctor feels that the potential benefit from it outweighs the risk. But it’s a fact that the drug can cause unexpected reactions in some cases and, therefore, there is a need to be vigilant,” he told ThePrint.
Increasing reports of adverse reactions
Tripathi explained that, in many cases, drug alerts regarding the safety of medicine are issued after there is considerable evidence from its post-marketing surveillance.
Also, though highly unlikely, some patients can report several allergic reactions despite previous uneventful exposure to the drug, he added.
Dr Rajeev Gupta, director, internal medicine, at Delhi’s C.K. Birla Hospital, also said that the latest alert may have come in response to increasing reports of adverse reactions associated with NSAIDs, especially Meftal.
“There has been a rise in cases of DRESS syndrome linked to Meftal and other NSAIDs,” he told ThePrint.
He added that patients with a history of similar reactions, first-degree (close) relatives with such reactions, or co-infections with viruses like herpes, Epstein-Barr, or cytomegalovirus, are at increased risk.
Speaking to ThePrint, Dr Rao pointed out that, while it is rare, the life-threatening DRESS syndrome can cause deaths in up to 10 percent of the patients who experience it.
What can you do?
Doctors advise that, for patients using the drug, there is a need to be vigilant for skin eruptions, swelling, or systemic symptoms, and seek medical attention promptly.
“This may be particularly important for individuals with a history of gastrointestinal bleeding and cardiovascular issues. Regular monitoring and adherence to prescribed doses help mitigate risks,” Rao said.
Patients should inform their doctors about any allergic reactions or pre-existing conditions to ensure the safe and effective use of mefenamic acid. It is also advised to promptly report any unusual symptoms during any medication prescribed by doctors.
Gupta stressed that early identification of DRESS syndrome is crucial to preventing fatalities.
“However, it can be challenging as symptoms may appear three to four weeks after starting or even stopping the medication. Long-term supportive management, including corticosteroids, is typically required,” he added.
(Edited by Richa Mishra)