The Drug Controller General of India (DGCI) has issued a notification to pharmaceutical companies to include a warning about possible kidney damage on the packaging of certain antacids used to treat acid reflux, heartburn, stomach ulcers, and other issues resulting from overproduction of acid in the stomach.
DGCI VG Somani has directed manufacturers of Proton Pump Inhibitors (PPI), a type of antacid, to include an ‘acute kidney injury’ warning on the packets as well as on patient information leaflets as an adverse drug reaction.
“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,” the DGCI wrote in a letter to state regulators, LiveMint reported.
This decision was reportedly taken after a meeting of several health experts at the Indian Pharmacopoeia Commission in August. A panel recommended this move at the event, the proposal for which was given a go-ahead by a subject expert committee of Central Drugs Standard Control Organization, led by Somani.
PPIs are some of the most commonly used drugs globally. Several researches have shown the linkage between long-term use of PPIs and chronic kidney disease (CKD) - one study that surveyed over 10,000 people found that there was a 20-50% higher risk of CKD in those who were using PPIs. It has also been linked to a higher risk of acute interstitial nephritis (AIN) and end-stage renal disease, according to some studies.
These studies show that chronic and prolonged use of PPIs can have a dangerous effect on the renal system (kidneys).
“Since the introduction of PPIs to the US market in 1990, several observational studies have linked PPI use to uncommon but serious adverse health outcomes, including hip fractures, (types of) community acquired pneumonia, Clostridium difficile infections, acute interstitial nephritis (AIN), acute kidney injury (AKI),” reveal the results of one study adding that it was likely and plausible that PPI use is linked to the development of CKD.
Some studies argue, however, that these risks are related to chronic use of PPIs, and the ideal usage is 4-8 weeks, beyond which if PPIs are prescribed, the patient should be monitored. Studies also recommend that physicians be aware of these risks, refrain from irrational prescription of these drugs, and be aware of appropriate ways to discontinue the medication.
PPIs work by inhibiting the proton pump (a system found in the stomach lining that helps make stomach acid). They are commonly prescribed for gastritis and mild ulcers. Individuals who are started on antibiotics may also be given a proton pump inhibitor (PPI) in an effort to reduce the resulting acid reflux.