Print warning about kidney injury on antacids: Drug Controller asks pharma
   Date :13-Nov-2019
 
By Rajendra Diwe :
 
EVERY alternate prescription of registered medical practitioners contains at least one molecule of antacid drug. However, rampant use of antacids belonging to ‘Proton Pump Inhibitors’ (PPIs) has increased ‘Acute Kidney Damage’ in patients. Taking note of this problem, the Drug Controller General of India (DCGI) V G Somani has directed the state regulators to ask pharmaceutical companies manufacturing proton pump inhibitors to include ‘acute kidney injury’ as an adverse drug reaction on patient information leaflets of drug packs. According to Pharmacology, Proton Pump Inhibitors (PPIs) are a class of drugs used to treat gastroesophageal reflux disease commonly known as heartburn, stomach ulcers and other conditions caused by overproduction of stomach acid.
 
These drugs include pantoprazole, omeprazole, rabiprazole, esomeprazole, lansoprazole etc. Despite researches by many associations of medical practitioners, use of these ‘antacids’ is continuing over the years. According to a study from market research firm AIOCD-AWACS, “This year till September, people of India have consumed PPIs worth Rs 1,854 crore.” A pharmacist, on condition of anonymity, said, “These Proton Pump Inhibitors are special class of drugs to be used for chronic conditions like ulcers. Unfortunately, each manufacturing company in India, whether it is of generic drugs or Propaganda Cum Distributors or loan licence or having patent, is busy in promoting PPIs to each and every doctor from urban as well as rural areas. More than 1000 brands of these drugs are on sale in the market. This may be the reason for rise in acute kidney diseases.”
 
DCGI has now asked pharmaceutical companies to warn patients about the risk of kidney damage on the packaging of certain antacids. The decision was taken on the recommendation of the Signal Review Panel-Pharmacovigilance Programme of India (SRP-PvPI) recommendations at its meeting held in Delhi at Central Drugs Standard Control Organisation (CDSCO) headquarters. In the meeting, the SRP evaluated the drug Proton Pump Inhibitor ADR on the basis of individual case study reports (ICSRs) and recommended to PvPI that CDSCO be informed to take necessary steps to incorporate acute kidney injury into PIL of Proton Pump Inhibitors.
 
Welcoming the decision of DCGI, Dr Manish Shrigiriwar, Dean of Government Medical College, Yavatmal said, “Prescribing proton pump inhibitors is a fashion nowadays. Right from big cities to small villages, these antacids are being prescribed in almost every prescription. Nine out of ten prescriptions have at least one proton pump inhibitor. It’s high time such decision was taken.” Referring to the article published in the Journal of Association of Physicians of India (JAPI), Dr Shrigiriwar said, “Proton pump inhibitors are the mainstay of treatment for acid peptic diseases (APDs), but are often irrationally prescribed in clinical practice. Appropriate prescription of PPIs is needed to optimise outcomes, and minimise risks and cost burden on healthcare system. People should at large be made aware about the rational use of PPIs.”
 
 
Several researches have shown that use of Proton Pump Inhibitors increases the risk of kidney damage. A study done on US Food and Drugs 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.
 
According to nephrologists, “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.”
 
According to a study from market research firm AIOCD-AWACS, “This year till September, people of India have consumed PPIs worth Rs. 1,854 crore.”
 
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.