NEW DELHI :
India’s apex drug regulator has asked pharmaceutical companies to warn patients about the risk of kidney damage on the packaging of certain antacids.
The Drug Controller General of India (DCGI) V.G. Somani, through state regulators, has asked companies manufacturing a class of drugs called proton pump inhibitors to include ‘acute kidney injury’ as an adverse drug reaction on patient information leaflets of drug packs.
Proton pump inhibitors are a class of drugs used to treat gastroesophageal reflux disease, also called heartburn, stomach ulcers and other conditions caused by overproduction of stomach acid. These drugs include pantoprazole, omeprazole, esomeprazole and lansoprazole.
“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," Somani said in a letter to state regulators. A copy of the letter, dated Monday, was reviewed by Mint.
Globally, some of the well known brands of proton pump inhibitors are Prilosec, Nexium and Prevacid.
Total sales of proton pump indicators in India over the year ending September was Rs1,854 crore, data from market research firm AIOCD-AWACS showed. During the period, 35.6 crore units of these products were sold. Best selling brands of proton pump inhibitors include Alkem Laboratories’ Pan, Sun Pharmaceuticals’ Pantocid, Zydus Cadila’s Pantodac and Cipla’s Pansec.
The decision follows a meeting of various health experts at the Indian Pharmacopoeia Commission in August, where a panel recommended the move. Then last month, the proposal got a thumbs-up from a subject expert committee of the Central Drugs Standard Control Organization (CDSCO), which is headed by Somani.
Several researches have shown that use of proton pump inhibitors increases the risk of kidney damage. A study done on US Food and Administration data by University of California – San Diego, and published in February, found that about 5.6% of patients who used only proton pump inhibitors to treat acidity reported kidney-related adverse reaction. The study had a sample size of 43,000.
“Proton pump inhibitors can cause kidney damage in two forms. One is acute kidney injury, called acute interstitial nephritis, which in layman terms is like an allergic reaction to the medicine. It is not very common but it does happen. The other is chronic kidney injury, which is caused by prolonged use of the medicine," Salil Jain, director and head of department of nephrology at Fortis Memorial Research Institute in Gurugram, said.