In a bid to promote patient safety, widely-sold antacids (anti-acidity pills) will hereon need to carry a side-effect warning of ‘acute kidney injury” as part of their package insert leaflets. A directive to that end was issued by India’s Drugs Controller General on Tuesday, asking all state regulatory authorities to direct manufacturers of Proton Pump Inhibitors (PPIs) — a large chunk of the antacid market — to incorporate ‘acute kidney injury’ as an adverse drug reaction (ADR). The warning will be inserted in the packaging of these formulations, including Pantoprazole, Omeprazole, Lansoprazole, Esomeprazole, and their combinations.

A package insert or prescription drug label is directed primarily at prescribers and is intended to provide information for safe and effective use of the drug.

The issue was discussed and case studies evaluated by several experts over the past few months, including the National Co-ordination Centre for Pharmacovigilance Programme, official sources said.

Recent global studies on anti-acidity pills — popped for treating “gas” and heartburn — have pointed out that there can be serious adverse events due to their prolonged use like long-term kidney damage, acute renal disease and chronic kidney disease, and in certain cases, even gastric cancer. Since these reports are mostly restricted to nephrology journals, many physicians may not be aware of these adverse effects, experts pointed out.

PPIs rank among the top 10 prescribed classes of drugs in a segment valued over Rs 4,500 crore and are commonly used to treat acid reflux and indigestion, but also deployed regularly across specialities like orthopaedics, cardiology, internal medicine and surgery.

The directive states the based on ADR reports on certain medicinal products including these antacids, the National Co-ordination Centre for Pharmacovigilance Programme forwarded their recommendations, which were discussed on August 21. Thereafter, an expert panel recommended steps to incorporate the warning as an adverse drug reaction into the prescribing information leaflet. The recommendation were then deliberated on October 10 in a subject expert committee and formalised.

When PPIs first came nearly 20 years ago to tackle acidity, the perception about these drugs was that they are very safe — this perhaps still lingers amongst a large section of gastroenterologists, physicians and other specialists. This has percolated down to patients as well, leading to their rampant use.

Earlier, US-based nephrologist Dr Pradeep Arora, who has published global research in BMC Nephrology, told TOI, “PPIs should be ideally prescribed in the approved indications, if possible for <8 weeks. Beyond which, if a patient is still on PPIs, the kidney function and magnesium levels need monitoring


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