Now, antacids must carry ‘kidney injury’ warning
Rupali.Mukherjee
Mumbai: In a bid to promote patient safety, widely-sold antacids (anti-acidity pills) will here on 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 Cont roller General on Tuesday, as king all state regulatory authorities to direct manufacturers of Proton Pump Inhibitors (P- PIs) a large chunk of 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 Coordination Centre for Pharmaco vigilance 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 ortho paedics, cardiology, internal medicine and surgery.
When PPIs first came nearly 20 years ago to tackle acidity, the perception about these drugs was that they are very safe.
Earlier, US-based nephrolo gist Dr Pradeep Arora, who has published global research in BMC Nephrology, told IRT that “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”.