‘Acute Kidney Injury’ warning a must on antacid medicines: Drug controller

The Drug Controller General of India (DCGI) has written a letter to pharmaceutical manufacturers through the Food and Drug Administration department to warn patients about the risk of kidney damage due to certain antacids. The DGCI has asked manufacturers to issue a warning on the pack itself


Soon, Proton Pump Inhibitors (PPIs) formulation manufactures will have to incorporate ‘Acute Kidney Injury’ warning on its packages.

A majority of people suffer from gas and heartburn regularly. It is so common that we tend to take an anti-acidity pill without consulting a doctor. We don’t think about the possible side effects of the medicine on our body, especially on our kidney.

But, soon, popular antacid medicines will have to carry a health warning which states that ‘Acute Kidney Injury’ can be caused.

In order to promote patient safety, the Drugs Controller General of India (DGCI), has issued a directive to all the states to direct Proton Pump Inhibitors (PPIs) manufactures to add a warning which conveys that ‘Acute Kidney Injury’ can occur as an adverse drug reaction.

The DCGI has asked the pharmaceutical manufactures to have a package insert warning.

The letter to the state drug controller states:

‘Various formulations of Proton Pump Inhibitors like Pantoprazole, Omeprazole, lansoperazole, Esomeprazole, Rabeprazole are marketed in the country

You are requested to direct the manufacturers of formulations of Proton Pump Inhibitors under your jurisdiction to mention Acute Kidney Injury as an adverse drug reaction in the package insert/promotional literature of the said drugs.’

According to doctors, Proton Pump Inhibitors (PPI’s) are medicines which work by reducing the amount of stomach acid produced by glands in the lining of your stomach.

Health experts have welcomed this move as many people have the habit of self-medicating themselves which is harmful to health.

While speaking to My Medical Mantra Dr Abhay Gadre, a nephrologist, attached with Pune’s Ruby Hall clinic informed, “Consuming a lot of antacids can cause harm to the kidneys. So, incorporating a health warning on the package will surely benefit the patients. People commonly pop antacids without consulting a doctor. Self-medication is always harmful. This will be a deterrent for those who self-medicate.”

While Dr Sudhir Kullkarni, Professor and HOD of the Nephrology department at MGM Hospital, Aurangabad, said, “The warning label will beneficial for the patients. They will realise that they shouldn’t take this medication without a doctor’s prescription. It will help increase patient safety. Even the doctors will be benefitted through this move.”

Globally, a lot of research has been carried out on medicines which help during problems of gas and heartburn. Researchers have revealed that long term exposure to these medications can likely cause kidney damage.

Dr Samveda Samel, an MD DNB, General Medicine, stated, “Not every patient who is on proton pump inhibitor develops chronic kidney disease but there are medical research studies which show that there is increased risk of chronic kidney disease, acute kidney injury, electrolyte imbalances who are on long term treatment with PPI and have other comorbidities like diabetes, hypertension.”

She added, “There is an increased risk of interstitial kidney disease which may be an allergic manifestation of these drugs so now FDA has issued a category B warning for these drugs which means that the medical fraternity as well as the patients should be careful about the dosing and the treatment schedule and duration of these drugs and should limit the over the counter misuse of these drugs.”