Proton Pump Inhibitors (PPIs) and Kidney Failure
In January 2016, researchers released the result of a study on proton pump inhibitors (PPIs), used to relieve stomach-acid related problems like heartburn and gastroesophageal reflux disease (GERD). They first reviewed data from about 10,500 participants, and found that those taking PPIs were more 20–50 percent more likely to suffer from chronic kidney disease (CKD).
When researchers again examined the medical record of more than 248,000 people treated in the Pennsylvania hospital system, they found similar results, with those using PPIs at an increased risk for CKD. Those taking other types of heartburn medication, called H2 blockers, did not suffer the same increased risk.
This and other studies showing similar results have alarmed both doctors and patients taking these drugs. They have been on the market since the 1980s and have been considered safe to use, but now healthcare professionals are taking a second look at the serious risks.
The Pittsburgh proton pump inhibitor attorneys at Chaffin Luhana stand ready to help those individuals who have taken heartburn medications and suffered serious complications, such as chronic kidney disease, kidney failure, heart attack, bone fractures, and more. If your life has been turned upside down by these drugs, please contact us today for a free initial consultation.
Proton Pump Inhibitors (PPIs) Seen as the Go-To Treatment for GERD
Proton pump inhibitors (PPIs) came on the scene in the late 1980s as the new approach to treating stomach-acid-related health problems, like heartburn, GERD, esophagitis, Barrett’s esophagus, peptic ulcer disease, and Zollinger-Ellison syndrome. Common PPIs on the market today include:
- Omeprazole (Prilosec)
- Lansoprazole (Prevacid)
- Pantoprazole (Protonix)
- Exomaprazole (Nexium)
These PPIs work by blocking the production of stomach acid. The normal stomach has cells that secrete acid in response to stimulation by enzymes. PPIs help inhibit these enzymes so they can’t tell the cells to secrete acid. The result is less acid, or a weaker acid, and relief of symptoms.
Because they worked so well—superior to previous treatments—PPIs became the go-to treatment for most acid-related conditions, and helped many people to find relief. They not only work well in reducing stomach acid, but they can also decrease the risk of inflammation of the esophagus and even esophageal cancer. Their use, however, comes with significant risks that doctors and patients were unaware of for decades.
Proton Pump Inhibitors and Chronic Kidney Disease
PPIs have previously been linked to a number of potential side effects (explained below). But the recent findings on chronic kidney disease have been especially concerning, because the risks are significant, and because the disease is so serious.
Chronic kidney disease is a condition in which the patient experiences a gradual loss of kidney function. The kidneys become so inflamed and damaged that they can no longer work as they should.
Kidneys regularly filter waste and excess fluids from the blood, and then flush the waste out through the urine. They also keep levels of electrolytes stable, like sodium, potassium, and phosphate, and make hormones that help regulate blood pressure, develop red blood cells, and keep bones strong.
When kidneys start to malfunction, the whole body is affected. Early symptoms are mild or nonexistent, but left untreated, chronic kidney disease can cause minor problems like nausea and vomiting, fatigue and weakness, loss of appetite, muscle cramps, and swelling of feet and ankles. As the disease progresses to kidney failure, complications may include cardiovascular disease, bone fractures, anemia, fluid retention around the lungs, and more.
Several very recent studies have indicated that PPIs can increase the risk of chronic kidney disease:
- April 2015: The CMAJ Open reports that those who took PPIs were more at risk for both acute nephritis (inflammation of the kidneys) and acute kidney injury.
- October 2015: The American Society of Nephrology reveals that a study led by Pradeep Arora, M.D., showed that participants using PPIs had a 10 percent increased risk of CKD and a 76 percent increased risk of dying prematurely.
- February 2016: JAMA Internal Medicine reports that those taking PPIs had a 20-50 percent increased risk of kidney disease compared to those who never took the drugs. Twice-daily dosing was associated a higher risk than once-daily dosing. The longer the patients took the drugs, the higher their risk. Researchers confirmed these findings in a second study involving data from about 250,000 participants.
- April 2016: The Journal of the American Society of Nephrology reports that PPIs are associated with a 96 percent increased risk of kidney failure and a 26 percent increased risk of CKD. Patients taking the drugs for 1-2 years were three times more likely to develop kidney failure than those using them for less than a month.
Caught early, CKD can be treated. Symptoms include:
- Nausea and vomiting
- Loss of appetite
- Fatigue and weakness
- Problems sleeping
- Changes in urine output; pain or burning while urinating; a frequent need to urinate
- Pain in the kidney or abdomen areas
- Muscle twitches and cramps
- Decreased mental sharpness/brain fog
- Swelling in feet and ankles
- Shortness of breath
- High blood pressure
Patients Suffer Serious PPI Side Effects
Over a period of several years, a number of other health risks have been associated with the use of PPIs. One of the first was dependency. Patients were finding that after they took PPIs for awhile, when they tried to stop taking them, their symptoms actually got worse. They were experiencing a rebound effect, where their acid-related conditions became more intense after stopping the medication than they were before they started taking it.
A 2009 study found evidence of a connection between use of PPIs and dependency. After 12 weeks, participants who took the drugs and then stopped taking them had more acid-related symptoms than those who never took the drugs in the first place. Researchers called the condition “rebound acid hypersecretion,” and noted that the drugs could lead to the stomach actually producing more acid in the long run.
Another couple of concerning side effects came to light in 2010. The first was birth defects. A 2010 study in NEJM found some evidence that newborns born to mothers who had taken PPIs right before or during the first trimester were more likely to be affected by birth defects than those who had not been exposed to PPIs. Though the researchers concluded that the difference was not significant, they advised that more studies needed to be conducted, as their results were not definitive. One of main PPIs, Prilosec, is listed as Pregnancy Category C, which means that animal studies have shown a potential risk to embryos and fetuses.
That same year, another study reported that long-term use of PPIs could increase risk of bone fractures. Researchers noted that the medications could affect the absorption of key nutrients like calcium, magnesium, and vitamin B12, which could increase risk of fractures of the hip, spine, and wrist. High doses were also found to be more concerning. Later studies would report similar results, with a large 2014 review of 34 studies reporting an association between PPI therapy and risk of fracture.
Building on the idea that PPIs affect nutrient absorption, later studies confirmed that the drugs affected how the body metabolized magnesium. In 2012, researchers reported that hypomagnesemia (low magnesium levels) was a recognized side effect of PPI use. Without treatment, the condition can lead to fatigue, muscle weakness, cramps and spasms, numbness, and even convulsions, and in more severe cases, heart attack. Later studies came to similar conclusions.
In 2015, scientists would find links between PPIs and heart disease. That year, PLoS One published two studies showing that PPIs could increase risk of heart attack by as much as 21 percent. Those who took the drugs and suffered from heart attacks were also twice as likely to die from them as those not taking the drugs.
Finally, in 2016, researchers also connected the use of PPIs with a higher risk for dementia and potentially Alzheimer’s disease. Those regularly taking the drugs were more at risk than those not taking them, and those 75 and older had a 44 percent increased risk.
In summary, potential side effects of proton pump inhibitor therapy may include:
- Hypomagnesemia and other nutrient malabsorption
- Rebound effect or dependency
- Chronic kidney disease
- Heart attack
- Bone fracture
- Birth defects
- Dementia and/or Alzheimer’s disease
The FDA Warns of PPI Risks
The FDA has released a number of safety communications over the years, warning about potential side effects of PPIs. In 2010, for example, they warned of a possible fracture risk with high-dose and long-term use, and announced that they were requiring the manufacturers to change their labeling to warn doctors and patients of the potential risk.
Other FDA warnings include:
- 2011: The administration warns that low magnesium levels could be associated with long-term use of PPIs.
- 2012: The FDA warns doctors that PPIs could be associated with an increased risk of clostridium difficile-associated diarrhea. This is a very serious digestive infection that is difficult to treat. They also required manufacturers to add this risk to their labeling.
Manufacturers Failed to Alert Doctors and Patients to the Health Risks
Though the FDA required manufacturers to update their labeling on some side effects, so far the drugs still carry inadequate warnings on things like dementia, birth defects, heart attack, and chronic kidney disease.
Patients who are using these drugs are often in the dark about the many risks associated with them. Doctors, too, may be unaware of the recent studies associating the drugs with chronic kidney disease. That makes these drugs particularly dangerous, especially because they are so widely used, and often patients use them frequently and for long periods of time, unwittingly putting themselves at risk for serious health ramifications.
Currently, more than 15 million Americans use PPIs—they are some of the most commonly prescribed medications in the country. Manufacturers received case reports of kidney injuries as early as 2004, but failed to take meaningful action to protect the public. A recent lawsuit filed in May 2016, for example, was filed by an Illinois man who suffered kidney failure after taking Nexium for several years. He had to go through a kidney transplant, and is seeking damages against manufacturer AstraZeneca.
Pittsburgh Area Residents May be Eligible to File PPI Lawsuits
Patients who have taken drugs like Nexium, Prilosec, Prevacid, and Protonix, and later suffered from serious injuries like chronic kidney failure or kidney disease may be eligible to file a PPI lawsuit. Many plaintiffs have already filed complaints against manufacturers of these drugs, stating that they failed to adequately address safety risks as they came up.
If you or a loved one suffered from chronic kidney disease, or kidney failure potentially caused by a PPI, the Pittsburgh attorneys at Chaffin Luhana LLP may be able to help. We understand that manufacturers like AstraZeneca and Procter & Gamble are responsible for making sure their products are safe before releasing them on the market.
Chaffin Luhana Pittsburgh attorneys represent individuals in West Virginia, Western Pennsylvania, and Eastern Ohio, and will give you an initial consultation for free. Contact us today.