A wide class of popular heartburn drugs, including Prevacid, has been linked to severe kidney disorders, researchers say, leading many patients to question the safety of their favored medications.
What Is Prevacid?
Prevacid’s active ingredient is called lansoprazole. The drug was first approved in 2005.
The prescription version of Prevacid is manufactured by Takeda Pharmaceuticals, the largest drug manufacturer in Japan and one of the fifteen largest pharmaceutical companies in the world. The company’s US subsidiary is headquartered in Deerfield, Illinois.
Since Takeda lost its patent on Prevacid’s active ingredient in 2009, numerous drug manufacturers have jumped into the market with their own generic versions of the medication. Swiss-based company Novartis markets an over-the-counter formulation, Prevacid 24hr, in the United States, licensing the name Prevacid from Takeda.
While Prevacid was once the country’s third best-selling drug, the release of other proton pump inhibitors hurt sales considerably. After Prilosec’s over-the-counter version was released in 2005, sales of Prevacid plunged by almost 43%, according to BioSpace. Notwithstanding these changes in the market, generic versions of Prevacid had claimed the 5th-highest spot in proton pump inhibitor sales as of 2013.
After Link To Kidney Failure, Drug Safety In Doubt
Proton pump inhibitors are extremely effective in controlling the production of gastric acid, but experts say that long-term use and rampant overprescription may be contributing to a wave of ill-health effects, from bone fractures and dementia to rare infections.
Several recent studies have now found that PPI users are up to twice as likely to develop debilitating kidney conditions than people using alternative treatments.
Kidney Disease Risk Seen In Thousands Of Patients
After tracking almost 10,500 people for nearly 14 years, researchers at Johns Hopkins University observed a troubling trend: patients taking proton pump inhibitors were more likely to suffer renal impairment.
Compared to people taking H2 blocker antacids like Zantac, PPI patients were 45% more likely to experience chronic kidney disease. This increased risk persisted even after the researchers controlled for various socioeconomic and demographic factors that can predispose people to kidney disease. Actually, it increased after these adjustments, to a heightened risk of 50%. But this association wasn’t enough.
To double-check their results, the scientists looked at a second patient group, gathered from health data compiled by a Pennsylvania-based healthcare network. More than 248,000 patients were involved. No matter how the researchers analyzed their dataset, proton pump inhibitor users were always at an increased risk for chronic kidney disease compared to those who never used them. Plus, the risk increased as the PPI dosage increased:
- one pill a day – 15% increased risk
- two pills a day – 46% increased risk
That’s strong evidence. When a drug actually causes an adverse effect, scientists usually assume that the effect will be increased by an increase in dosage. As we’ve seen, this is precisely the trend the Johns Hopkins researchers discovered.
Why Is Chronic Kidney Disease Skyrocketing?
Health experts have been trying to explain why chronic kidney disease rates have been rising lately, while the known risk factors for CKD, like diabetes and hypertension, have been growing at much slower rates.
The incidence of chronic kidney disease has skyrocketed in recent years, according to statistics maintained by the National Institutes of Diabetes and Digestive and Kidney Diseases. In 2000, less than 2% of people over the age of 65 were diagnosed with the condition. By 2008, that proportion had more than doubled, to just under 4.5% new diagnoses.
Known Risk Factors Remain Stable
Common risk factors for chronic kidney disease, on the other hand, are either on the decline or stable. Smoking, of course, is down across all age ranges. While shockingly high, obesity rates have also stabilized over the last decade.
Diabetes, high blood pressure – none of the known health risks for chronic kidney disease have ballooned like the rate of chronic kidney disease itself has.
Proton Pump Inhibitors Overprescribed
As Medscape Multispecialty recently reported, some researchers now believe that proton pump inhibitors, including Prevacid, could be at the root of this growing problem. Unlike smoking, obesity or diabetes, proton pump inhibitors have exploded in usage.
Between 2001 and 2010, emergency department prescription of PPI drugs more than doubled. This drastic increase is just one manifestation of a widespread phenomenon. Almost immediately after doctors began using proton pump inhibitors, they began over-using them.
It’s not hyperbole to suggest that PPI overprescription is an epidemic in the healthcare industry. Today, proton pump inhibitors “are ubiquitous in a gastroenterologist’s practice,” says Dr. David Johnson, chief of gastroenterology at Eastern Virginia Medical School. Researchers now take this fact for granted but have expressed concerns about the health effects that rampant use could pose.
Long-Term Use: More Harm Than Good?
Proton pump inhibitors were never meant to be used forever. These drugs are a short-term solution for conditions like acid reflux disease or Zollinger-Ellison syndrome, which can be worsened by the production of gastric acid.
When PPIs first hit the market, we didn’t even have safety information on their long-term health effects – because they were never meant to be used that way. But now that several formulations have been approved for over-the-counter sale, and physicians have started prescribing the drugs without a second thought, we’re gaining more and more information on how proton pump inhibitors can harm patients in the long-term.
Potential Side Effects
None of this information has been optimistic. In recent years, researchers have linked Prevacid to increased risks for:
- broken bones and osteoporosis
- heart attacks
- hypomagnesemia – a dangerously low level of the mineral magnesium
- birth defects
- community-acquired pneumonia
- Clostridium difficile (C diff) infections
Kidney disorders are just the most recent addition to this growing list of potential side effects. But some physicians suggest that the newfound link between Prevacid and kidney disease wasn’t unexpected.
The troubling new evidence comes less than two years after proton pump inhibitors were linked to an acute form of kidney injury, acute interstitial nephritis. That discovery warranted an FDA-mandated change in warning labels, but no PPI manufacturer – including Takeda Pharmaceuticals, the company that makes Prevacid – has announced a public warning about chronic kidney disease or kidney failure.
Lawsuits May Be Possible
Although no Prevacid lawsuits have yet been reported, other proton pump inhibitors have already come under fire for alleged cases of chronic kidney disease and kidney failure. Several patients have already filed lawsuits against the manufacturer of Nexium, accusing the company of hiding medical evidence from the public.
Legal experts say that Prevacid users should take note – especially those who have already been diagnosed with kidney disorders. Compensation may be available, including money to cover medical expenses and lost wages.