New Delhi: The Drugs Controller General of India has asked the Central Drugs Standard Control Organisation (CDSCO) to ask state drug controllers to direct manufactures of formulations of Proton Pump Inhibitors (PPI) to mention ‘acute kidney injury’ as an adverse drug reaction in the package of these medicines.
Simply put, these medicines, often available as over-the-counter antacids, will have to carry the ‘adverse kidney injury’ warning from now.
This is a significant step towards patient safety. The US FDA has also recommended that these drugs should be taken on specific indications and for not more than eight weeks.
Antacids are taken to suppress acids in the stomach. However, there is a tendency for indiscriminate use as a result of which a patient often gets addicted to the drug.
The advisory came after the National Coordination Centre Pharmacovigilance Program of India raised concerns. A note that was forwarded in the form of a recommendation based on adverse drug reaction (ADR) reports on certain medical products, including Proton Pump Inhibitors, were discussed.
The objective was to signal information leaflet change from Indian data and promote patient safety. Subsequently, the recommendations were deliberated upon at a meeting held on October 10 at CDSCO. The committee recommended the label warning and this has now been incorporated.
A study done by the American Medical Association, researchers at Yale and John Hopkins reviewed two groups of patients. Out of 10, 482 patients taking PPI, more than 50% were likely to suffer from chronic kidney disease. Taking two pills a day was linked to a 46% jump in risk for kidney diseases.