Government issues safety warning against Meftal; here's what expert says

The Indian Pharmacopoeia Commission (IPC) has cautioned the public against the use of Meftal, a medication commonly employed as a pain reliever for conditions such as menstrual cramps, rheumatoid arthritis, osteoarthritis, dysmenorrhea, mild to moderate pain, inflammation, fever, and dental pain.

The commission, following an initial review of drug reactions in the Pharmacovigilance Programme of India (PvPI) database, identified cases of a syndrome known as drug reactions with Eosinophilia and Systemic Symptoms (DRESS).

Meftal is a combination of two drugs, dicyclomine and mefenamic acid.

Individually, both dicyclomine and mefenamic acid play crucial roles in the body. When used in tandem, they alleviate menstrual and stomach cramps. Dicyclomine relaxes stomach and gut muscles, preventing sudden muscle contractions, thereby relieving cramps, pain, bloating, and discomfort. Simultaneously, mefenamic acid, a non-steroidal anti-inflammatory drug (NSAID), reduces abdominal pain and inflammation by blocking specific chemical messengers.

As per the IPC alert, mefenamic acid in Meftal may lead to negative reactions associated with DRESS syndrome.

"The alert issued by IPC was to advise Doctors and patients to monitor the possibility of an adverse drug reaction (ADR) 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," Blue Cross Laboratories, which manufactures of Meftal and Meftal Spas drugs, said in a statement. 

"Mefenamic acid, apart from India (as Meftal and Meftal-Spas) is being prescribed in countries like USA, UK, Japan, etc for more than four decades with billions of doses administered and has benefitted millions of patients," the company said, adding: "Blue Cross Laboratories as a responsible company has a strong pharmacovigilance system internally and supports the efforts of PvPI."

Dr Harsh Bhatt, Critical Care Consultant, Rjn Apollo Spectra Hospital, answered a few questions on the matter:

Recent studies have shown that Meftal can adversely affect kidney function. Prolonged use may damage the kidney, potentially causing chronic kidney disease with elevated urea and creatinine levels, leading to renal failure. The Drug Regulatory Department of India has imposed restrictions on the drug and may consider a complete ban in the future, says Bhatt.

When do doctors prescribe it?

Doctors generally prescribe Meftal for abdominal pain caused by abdominal infections. Gynaecologists may recommend it to females experiencing lower abdominal pain during menstruation.

Are there other harmful drugs available without a prescription?

Dr. Bhatt highlighted that several drugs, including Diclofenac and Aceclofenac, can be equally harmful when used for an extended period. While controlled use for treating diseases is not harmful, prolonged usage can negatively impact various organs such as the liver, kidneys, lungs, and heart.

Why do medical stores sell it without a prescription?

Bhatt explained that if a drug is banned by the drug regulatory department, it should not be sold in medical stores. However, he noted that in India, legal loopholes may allow the sale of such drugs without repercussions.

Bhatt advised, "People should be educated regarding all these things as to how to use drugs in the right way and also consult a good medical person for their disease problem so they will be prescribed the right medication."