Today let’s talk about the latest ban on Meftal, a non-steroid anti-inflammatory drug (NSAID) used for the treatment of menstrual and abdominal cramps.
Meftal: indications
It is a painkiller commonly used for the treatment of abdominal and menstrual cramps, arthritis, inflammatory pain, fever, and dental pain.
Gastroenterologists prescribe Meftal for abdominal pain due to infections.
Gynecologists prescribe Meftal for lower abdominal pain during menstruation.
The recent ban on Meftal
The government of India, specifically the Indian Pharmaceutical Commission (IPC) has recently issued a ban on this particular drug.
Why does a country ban a drug?
Before a drug reaches the market, it goes through a thorough pre-clinical trial (in animals) followed by four stages of clinical trials (in humans). These trials take up several years depending on the drug before it is finally approved for sale and marketing. However, some drugs require continuous monitoring to check for the long-term effects of the drug.
Serious adverse events that led to Meftal Ban
The IPC has noticed a series of reactions (syndromes) known as drug reactions with Eosinophilia and Systemic Symptoms (DRESS) to the drug that has resulted in its eventual ban.
To understand this syndrome, let us look at the constituents of Meftal
Components of Meftal
It is a combination of two drugs: dicyclomine and mefenamic acid.
Both play very crucial roles in the body and when taken together help to reduce stomach and menstrual cramps.
Dicyclomine works by relaxing the stomach muscles thereby helping reduce cramps, pain, and bloating
Mefenamic acid works by blocking certain messengers and thereby reducing pain and inflammation.
According to the latest news, Mefenamic acid could lead to adverse events associated with DRESS. IPC advises doctors and patients to avoid the usage of mefenamic acid and to immediately report any serious adverse events.
Adverse effects of Mefenamic acid
It causes adverse reactions including rashes and hypersensitivity with over 10% mortality rate.
They adversely affect kidney function. It elevates urea and creatinine levels thereby leading to chronic renal failure.
Frequent usage of the drug can result in reversible infertility as it blocks the enzyme Cyclooxygenase (COX). However, it resumed ovulation upon stopping the medicine.
Meftal and DRESS
Drug reactions with Eosinophilia and Systemic Symptoms (DRESS) syndrome is due to a drug reaction characterized by rashes. It is a rare but life-threatening condition and hence needs close monitoring.
Patients with DRESS syndrome exhibit several symptoms including rashes, high temperature, swollen lymph nodes, and even internal organs like the liver, kidney, and heart. It usually starts 2-8 weeks after consuming the drug.
What makes it a life-threatening condition is its involvement of hepatitis, myocarditis, pericarditis, colitis, etc.
Nearly 90% of the cases involve eosinophilia (too many eosinophils in the body) and 40% involve mononucleosis (severe infection)
Now that it has been identified, any adverse reaction involving DRESS needs immediate reporting and the causative drug needs to be withdrawn. Treatment for DRESS is purely symptomatic in the form of corticosteroids.
Comment below if you have heard of ban on any other drug in India or other countries.
Thanks for sharing!