Proton Pump Inhibitors May Cause Bone Fractures. Parker Waichman LLP offers free legal evaluations to victims Proton Pump Inhibitor injuries. If you or someone you know suffered injuries due to PPI use, we urge you to contact Parker Waichman LLP today for a free, no obligation PPI lawsuit evaluation.
Proton pump inhibitors (PPI) are a type of heartburn drugs taken by millions of patients and have been associated with various health issues such as serious kidney damage, bone fractures, and dementia.
Research Finds Association Between PPIs and Early Death
Every year, millions of Americans take the popular proton pump inhibitor (PPI) medications Nexium, Prilosec, and Prevacid to treat heartburn, ulcers, and other gastrointestinal problems.
But evidence is accumulating that these drugs are linked to a variety of serious health problems, including serious kidney damage, bone fractures, and dementia.
The latest disturbing finding is a new study published in 2017 showing a 25 percent increased risk of death among people taking a PPI compared to people taking an H2 blocker heartburn medication. The researchers calculated that, for every 500 people taking PPIs for a year, there is one extra death that would not have otherwise occurred.
Given the many millions of people who take PPIs regularly, this could translate into thousands of extra deaths every year, according to Dr. Ziyad Al-Aly, an assistant professor of medicine at Washington University School of Medicine in St. Louis, one of the study’s authors. The research team included others at Washington University, as well as doctors in the VA St. Louis Health Care System.
Using Department of Veterans Affairs databases, the researchers built cohorts of patients who received an outpatient H2 blocker or PPI prescription between October 1, 2006 and September 30, 2008. The researchers excluded patients who had received an H2 blocker or PPI prescription before September 30, 2006. Patients were grouped according to whether their acid suppression medication was a PPI (275,977) or an H2 blocker (73,335). The researchers compared risks for H2 blocker and PPI users and found an increased risk of death among PPI users.
Dr. Al-Aly said, “People have the idea that PPIs are very safe because they are readily available, but there are real risks to taking these drugs, particularly for long periods of time.” If Dr. Al-Aly needed a PPI, he said “absolutely” he would take one. But would want his doctor to carefully monitor him and he would want the doctor to discontinue the PPI as soon as it was no longer needed.
People should not assume that over-the-counter (OTC) drugs are safe to use freely and without a doctor’s advice. Patients should tell their doctors about all medications they use and discuss side effects, interactions, and precautions.
PPIs and Kidney Disease
Research has also linked PPI use to “silent kidney disease” that may go undetected for years. In a February 2017 article in the journal Kidney International, the researchers said their study results “indicate kidney problems can develop silently and gradually over time, eroding kidney function and leading to long-term kidney damage or even renal failure.”
In more than five years of follow-up, the researchers analyzed data from 144,032 people in the Department of Veterans Affairs database: 125,596 participants were new users of PPIs and 18,436 were new users of another family of heartburn drugs, H2 blockers (Pepcid, Tagamet, and Zantac). The researchers at Washington University in St. Louis found that over half of those using PPIs who developed chronic kidney damage and end-stage renal failure did not experience acute kidney problems. Only 7.67 percent of the group taking H2 blockers developed chronic kidney damage without experiencing acute kidney problems and 1.27 percent developed end-stage renal failure.
The researchers said doctors should monitor kidney function in patients who use PPIs, even in the absence of acute kidney problems.
PPIs and Fractures
Have you experienced a fracture while taking Nexium, Prilosec, or Prevacid? These heartburn drugs have been linked to an increased risk of fractures of the hip, wrist, and spine. In May 2010, the U.S. Food & Drug Administration (FDA) announced that it was revising the safety labels for both prescription and OTC PPIs to reflect this risk.
Each year doctors write about 113.4 million prescriptions for PPIs to treat conditions like gastroesophageal reflux disease (GERD), stomach ulcers, and other disorders. Even more people rely on OTC PPIs to deal with heartburn and stomach issues.
The PPI fracture lawyers at Parker Waichman believe thousands of people may have suffered broken bones as a result of these popular medications. Yet, most victims of PPI-related fractures probably have no idea that the drugs played a role in their injuries.
If you broke your hip, wrist, or spine while taking one of these medications, our PPI fracture lawyers want to hear from you. You may be entitled to compensation for your medical bills, lost wages, and pain and suffering. We urge you to contact us right away to protect your legal rights.
Proton Pump Inhibitors and Hypomagnesemia
The long-term use of proton pump inhibitors has been associated with hypomagnesemia, a condition caused by low levels of magnesium in the blood. In March 2011, the U.S. Food & Drug Administration (FDA) mandated that the makers of prescription proton pump inhibitors include information about the potential risk of low magnesium in the WARNINGS AND PRECAUTIONS sections of the labels for all prescription proton pump inhibitors. Proton pump inhibitors subject to the new warnings included: Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, AcipHex, and Vimovo.
Low serum magnesium levels may result in serious adverse events including:
- Muscle spasm
- Arrhythmias (irregular heartbeat)
- Seizures
According to the FDA, hypomagnesemia has been reported in adult patients taking proton pump inhibitors for at least three months, but most cases occurred after one year of treatment. Approximately one-quarter of these cases required discontinuation of proton pump inhibitor treatment in addition to magnesium supplementation. It is not understood why long-term proton pump inhibitor treatment sometimes results in hypomagnesemia. The FDA has recommended that healthcare providers consider testing a patient’s magnesium levels before the patient begins treatment with a prescription proton pump inhibitor. The agency said doctors should also consider periodic testing if patients are also being treated with medications such as digoxin, diuretics, or drugs that may cause hypomagnesemia. In digoxin patients especially, low magnesium may increase the likelihood of serious side effects.
FDA Warning
PPIs work by reducing the amount of acid in the stomach. Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, and Vimovo are available by prescription to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Less stomach acid reduces irritation of the stomach lining and allows ulcers and irritation of the esophagus to heal, WebMD explains.
Prilosec OTC, Zegerid OTC, and Prevacid 24HR are sold OTC for the treatment of frequent heartburn.
For patients with chronic heartburn and other stomach problems, PPIs are helpful. Unfortunately, long-term use of PPIs may come with a price. Several recent scientific studies found that people, especially women over 50, were more likely to suffer fractures, especially of the wrists, spine and hips, if they have taken PPIs for longer than one year.
According to an FDA Drug Safety Communication published in May 2010, these PPI studies used claims data from computerized administrative databases to evaluate the risk of fractures of the hip, wrist, and spine in patients treated with PPIs compared to individuals who were not using PPIs. The studies were generally six months in duration. Six studies reported an increased risk of fractures with the use of PPIs. Exposure to PPIs ranged from a period of one to 12 years, depending on the study. The emergence of fractures varied among studies; with one study reporting an increase in fractures with use of PPIs in the previous year and another study finding an increase after five to seven years of PPI use.
The increased risk of fractures seen in the studies was primarily observed in older individuals. Two studies reported an increase in fractures with higher doses of PPI, and two studies reported an increase in fractures with longer duration of use.
According to the FDA, only one study did not find a relationship between PPI use and fractures. This study limited the subject population to those without major risk factors for fracture.
Following a review of these studies, the FDA decided to revise the Warnings and Precautions section of the prescription labeling as well as the OTC Drug Facts label for PPIs. The FDA advised that health care professionals and consumers should weigh the known benefits against the potential risks of PPIs when determining if these medications are appropriate for treatment. Consumers also should talk with their health care professionals about any concerns.
It is important that people using OTC versions of the medications read and follow the directions on the OTC Drug Facts label. According to the FDA, such PPIs should only be used as directed for 14 days for the treatment of frequent heartburn. No more than three 14-day treatment courses should be used in one year. If your heartburn continues, talk to your healthcare professional.
Legal Help for Victims of PPI
Fractures
We offer a free case evaluation to victims of possible PPI-related fractures and other injuries. If you or someone you know took a prescription PPI such as Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, or Vimovo, we urge you to contact us today.
We also offer free consultations to fracture victims who took OTC versions of these drugs, including Prilosec OTC, Zegerid OTC, and Prevacid 24HR. Please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with one of our PPI fracture lawyers today.
Our lawyer for PPI injury is here to help you when you need it the most.
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