Govt Issues Alert on Newfound Side-Effect of Painkiller Meftal, Experts Say Was Already Known

Pharma standard body Indian Pharmacopoeia Commission (IPC) has issued a drug safety alert for doctors and patients about the use of the commonly used painkiller mefenamic acid, popularly sold under the brand name Meftal.

The Pharmacovigilance Program of India (PvPI), which monitors and collects information about adverse drug reactions (ADRs) and adverse events associated with pharmaceutical products, in its ‘preliminary analysis’ has found that the drug mefenamic acid triggers drug reactions with eosinophilia and systemic symptoms called DRESS syndrome.

While the drug is not an OTC product which can be sold without a prescription, it is widely used by Indians for different reasons such as for relieving menstrual pains, headaches, and muscle and joint pain. Also, the use of the drug is rampant among children in cases of high fever.

The top brands in the category include Blue Cross Laboratories’ Meftal, Mankind Pharma’s Mefkind P, Pfizer’s Ponstan, Serum Institute’s Mefanorm and Dr Reddy’s Ibuclin P.

What is DRESS Syndrome?

DRESS syndrome, short for Drug Rash with Eosinophilia and Systemic Symptoms, is a serious allergic reaction. It can be deadly, with around 10 per cent people experiencing this reaction passing away.

This syndrome occurs when your body reacts strongly to certain medications. It shows up as a skin rash and can affect your internal organs. It’s essential to be cautious about medications to avoid this severe reaction.

Side effects rare, already known: Doctors

The alert has asked healthcare professionals and patients to closely monitor the side effects of the medicine.

“Healthcare professionals, patients and consumers are advised to closely monitor the possibility of the above adverse drug reactions (ADR) associated with the use of the above suspected drug,” the alert said.

“If, such a reaction is encountered, please report to the IPC by filing of suspected adverse drug reactions.”

However, multiple doctors told News18 that DRESS syndrome is a commonly known side-effect of many nonsteroidal anti-inflammatory drugs (NSAIDs). Hence, it was already common knowledge even before the IPC’s preliminary analysis.

“While not as common as with some other drug classes, NSAIDs like ibuprofen and naproxen have been implicated in causing DRESS syndrome in some cases,” said a medical expert who works at the internal medicine department of a hospital in Delhi.

“It’s important to note that individual responses to medications can vary, and not everyone taking NSAIDs will experience this severe allergic reaction,” he said, adding that in his 20 years of clinical practice, he hasn’t witnessed any of his patients facing side effects from this drug.

Another doctor, a gynaecologist at a Gurugram-based hospital, told News18 that “the occurrence of DRESS syndrome with NSAIDs like Meftal is generally considered rare”.

“While the overall incidence is low, it is crucial for individuals taking NSAIDs to be aware of potential side effects, including rare but severe reactions like DRESS syndrome.”