Gastroenterologists and drug companies love proton pump inhibitors (PPIs). These drugs help calm heartburn, reduce irritation from reflux and heal ulcers. So much money has been made from drugs like dexlansoprazole (Dexilant), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix) and rabeprazole (AcipHex) that it boggles the mind. At last count (not including OTC use of drugs like Prevacid 24HR, Prilosec OTC or Nexium 24HR), 15 million Americans were taking a PPI annually at a cost of at least $10 billion.
How Safe Are PPIs?
Ever since omeprazole was marketed in 1989, first as Losec and then as Prilosec, this drug and its chemical cousins have been considered extremely safe by health professionals. Gradually, though, reports of complications started accumulating. We began hearing that PPIs could deplete the body of magnesium and possibly make it harder to absorb calcium from the diet. Then there were warnings about weakened bones and fractures, intestinal infections with C. diff, pneumonia and cardiovascular complications.
Kidney Damage: A Side Effect Doctors Did Not Anticipate:
The medical community and the FDA did not seem to pay much attention to case reports that began cropping up in the medical literature around 2006 linking PPIs to kidney damage. Australian researchers noted 10 years ago in the journal Clinical Gastroenterology and Hepatology (May, 2006):
“Proton pump inhibitors (PPIs) are a widely prescribed class of drugs, and their usage worldwide is increasing. Although well-tolerated, there have been case reports and a recent case series implicating these drugs in acute interstitial nephritis (AIN) and progression to acute renal failure (ARF).”
The authors concluded:
“With the ever more widespread use of this class of medications, PPI-induced AIN is likely to become more frequent. There is now evidence to incriminate all the commercially available PPIs, suggesting there is a class effect. Failure to recognize this entity might have catastrophic long-term consequences including chronic kidney disease. Increased awareness might facilitate more rapid diagnosis and management of this potentially reversible condition.”
New Data: PPIs and Kidney Function:
The prediction that health professionals could be facing catastrophic consequences if they ignored the early case reports appears to be coming true. Earlier reports that PPIs might affect kidney function have been reinforced by a new study from the Department of Veterans Affairs (Journal of the American Society of Nephrology, online April 14, 2016) .
Scientists reviewed the medical records of hundreds of thousands of patients in the VA system. There were 20,270 individuals who had recently been prescribed a drug such as esomeprazole (Nexium) or omeprazole (Prilosec), and 173,321 who were taking a different type of heartburn medicine such as ranitidine (Zantac) or cimetidine (Tagamet).
None of the patients had kidney function problems at the start of the study, but after five years the investigators found that those on PPIs were 28 percent more likely to have developed chronic kidney disease. They were also 96 percent more likely to experience end-stage renal disease, although the total number of people having that extreme outcome was quite small.
Where is a Black Box Warning from the FDA?
We fear that most health professionals are unaware of the FDA’s warning that kidney damage in the form of interstitial nephritis “has been observed in patients taking PPIs…” The agency seems to blame reduced kidney function on an unexplained allergic-type reaction and suggests that the drugs be discontinued if it occurs.
In our opinion, this warning is not strong enough by half. We think the FDA should require a black box warning (the strongest possible alert) for all proton pump inhibitors. When your kidney function is compromised bad things can happen.
What About OTC PPIs?
What’s even more disconcerting is that OTC products do not come with any mention of kidney function problems or what symptoms to be alert for. Perhaps the FDA assumes that everyone will read the label and only use products like Nexium 24HR for two weeks at a time (as indicated on the label). Many consumers assume that OTC drug products are super safe; otherwise they couldn’t be sold without a prescription. Some may not bother to read directions that say:
- do not use for more than 14 days unless directed by your doctor
- you may repeat a 14-day course every 4 months
- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
What do you think about proton pump inhibitors and kidney damage?
Dorothy in Turlock, CA offered this:
“I have been on PPI’s for one year. Have a declining kidney function, showing high creatine, etc. Am sure age has something to do with that, but I would like to not take the PPI if it is causing my kidney function to worsen. Anyone know how to approach getting off? My drug is Protonix and I am also taking Zantac.”
How can you Get Off a PPI Without Withdrawal? Here is a link!
Share your own PPI story below.
