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Proton Pump Inhibitors

Proton Pump Inhibitors Side Effects Lawsuits | Side Effects: Femur Fractures, Hip Fractures, Spine Fractures, Wrist Fractures | Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex

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Proton Pump Inhibitors Linked To Fractures Lawsuits

Proton Pump Inhibitors | Lawsuits, Lawyers | Side Effects: Fractures, Hip Fractures, Spine Fractures, Wrist Fractures | Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex

Have you experienced a fracture while taking Nexium, Prilosec, Prevacid? These heart burn drugs, known as proton pump inhibitors (PPIs), 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 over-the-counter 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 over-the-counter (OTC) PPIs to deal with heart burn and stomach issues.  Our PPI fracture lawyers 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 injury.

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 subjected to the new warnings included: Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, AcipHex, and Vimovo.

Low serum magnesium levels can 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 a 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 obtaining serum magnesium levels before their patients begin treatment with prescription proto pump inhibitors. The agency said they 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 can 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. Prilosec OTC, Zegerid OTC, and Prevacid 24HR are sold over-the-counter for the treatment of frequent heartburn.

For patients with chronic heart burn and other stomach problems, PPIs are a godsend. Unfortunately, long-term use of PPIs can 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've also taken PPIs longer than a 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.

According to the FDA Drug Safety Communication, six studies reported an increased risk of fractures with the use of PPIs. Exposure to PPIs ranged from a period of 1 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 5 to 7 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 has 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 professional 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. If you or a loved one 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.

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Study Finds PPIs Significantly Increase C. Diff Risk

Jul 11, 2012 | Parker Waichman LLP
Proton pump inhibitor drugs (PPIs) significantly increase the risk of a person developing Clostridium difficile-associated diarrhea (CDAD), according to a new study.Researchers at Harper University Hospital in Michigan and University of Utah School of Medicine discovered that people taking PPI drugs like Aciphex, Nexium, Omeprazole, Prevacid, Prilosec, and Protonix, are two-thirds more likely to develop CDAD than those not taking any of these drugs. PPI drugs are among the most commonly...

Proton Pump Inhibitors Signicantly Increase Risk of C-Diff

May 10, 2012 | Parker Waichman LLP
A new comprehensive study of the effects of Proton Pump Inhibitor (PPI) drugs like Nexium, Prevacid, Prilosec, and Protonix has revealed their association with a greater risk of the life-threatening Clostridium difficile infection (C-diff. or CDI). According to a report at FamilyPracticeNews.com, researchers at the European Congress of Clinical Microbiology and Infectious Diseases have discovered a “robust association” between the popular and widely-prescribed...

PPIs May Impact Magnesium Levels, Cause Fractures, U.K. Drug Regulator Warns

Apr 20, 2012 | Parker Waichman LLP
Patients in the U.K. are being warned that prolonged use of proton pump inhibitors (PPI) may be associated with an increased risk of fractures, as well as a condition called hypomagnesaemia.  The U.K.'s Medicines and Healthcare Regulatory Agency (MHRA), has issued guidance to doctors and patients there regarding these possible PPI side effects.Hypomagnesaemia is an electrolyte disturbance in which there is an abnormally low level of magnesium in the blood.  Left untreated, this...

FDA Warns PPIs May Cause Severe Diarrheal Infection

Feb 9, 2012 | Parker Waichman LLP
Patients who take proton pump inhibitors (PPIs) may be at a higher risk of developing a serious condition called Clostridium difficile–associated diarrhea (CDAD).  The danger prompted the U.S. Food & Drug Administration (FDA) to issue a Drug Safety Communication yesterday, and announce that it was working with the makers of PPIs to add information about their association with CDAD to the drug's labels.CDAD is a type of diarrhea that does not improved.  It is caused by...

Older Women Face Hip Fracture Risk from PPIs

Feb 1, 2012 | Parker Waichman LLP
Post-menopausal women, especially if they smoke, might want to think twice about taking a proton pump inhibitor (PPI) to relieve heartburn.  According to a new study in the British Medical Journal (BMJ), post-menopausal women who take PPIs like Nexium, Prilosec and Prevacid for two years or more increase their risk of sustaining a hip fracture by 35 percent.The study also found that women who took the PPIs for six to eight years were 50 percent more likely to suffer a broken hip....

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