#prevacid

Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School of Medicine in St. Louis shows that longtime use of the drugs also is associated with an increased risk of death.

Millions of U.S. residents take proton pump inhibitors which are widely prescribed to treat heartburn, ulcers and other gastrointestinal problems. The drugs also are available over the counter under brand names that include Prevacid, Prilosec and Nexium.

For the study, the researchers examined medical records of some 275,000 users of PPIs and nearly 75,000 people who took another class of drugs - known as H2 blockers - to reduce stomach acid. The research is published online July 3 in the journal BMJ Open.

"No matter how we sliced and diced the data from this large data set, we saw the same thing: There's an increased risk of death among PPI users," said senior author Ziyad Al-Aly, MD, an assistant professor of medicine. "For example, when we compared patients taking H2 blockers with those taking PPIs for one to two years, we found those on PPIs had a 50 percent increased risk of dying over the next five years. 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."

Brand Name: Prevacid

Generic Available

Common Dosage Forms:

Capsules, delayed release: 15 mg (OTC), 30 mg

Tablets, orally-disintegrating (SoluTab): 15 mg, 30 mg

Powder for Suspension: 3 mg/mL after reconstitution

FDA Indications/Dosages:

Short-term treatment of active duodenal ulcer: 15 mg daily before a meal for 4 weeks.

Treatment of duodenal ulcer associated with Helicobacter pylori:

>Triple Therapy: 30 mg lansoprazole daily plus 500 mg clarithromycin and 1 g amoxicillin given three times a day for 10-14 days.

>Double Therapy: 30 mg lansoprazole daily plus 1 g amoxicillin three times daily (for those intolerant or resistant to clarithromycin).

Short-term treatment of gastric ulcers: 30 mg once daily for up to 8 weeks.

To reduce the risk of ulcer formation in patients taking NSAIDs, give 15 mg once daily for up to 12 weeks.

To maintain the healing of erosive esophagitis: 30 mg daily before a meal for up to 8 weeks, for those patients who do not heal an additional 8 weeks of therapy may be useful.

To maintain the healing of erosive esophagitis and gastric ulcers: 15 mg given once daily.

Treatment of gastroesophageal reflux disease in patients over the age of 1 year: 15 mg once daily for up to 8 weeks.

Pathological hypersecretory conditions including Zollinger-Ellison syndrome: The dosage varies with the individual patient. The recommended adult oral starting dose is 60 mg once a day. Dosages should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice a day have been administered. Daily dosages of greater than 120 mg should be administered in divided doses.

Use in patients with nasogastric (NG) tubes: Open capsules and mix in 40 mL apple juice and inject through the NG tube.

Monitor: BMD, Mg

Pharmacology/Pharmacokinetics: Lansoprazole inhibits the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. This enzyme system is involved in the movement and production of gastric acid. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The absorption of lansoprazole is rapid, with peak levels occurring within 1.7 hours and having a half-life of approximately 1.5 hours. Absorption rate and amount is reduced by as much as 50% if the drug is given 30 minutes after food as opposed to the fasting condition. Lansoprazole is extensively metabolized in the liver. Lansoprazole is thought to be transformed into two active species which inhibit acid secretion within the parietal cell canaliculus but are not present in the systemic circulation. Therefore, although the plasma half-life is less than 2 hours the acid inhibitory effect lasts more than 24 hours. Lansoprazole is 97% bound to plasma proteins.

Drug Interactions: Lansoprazole should be taken 30 minutes prior to sucralfate. Because lansoprazole causes a profound and long-lasting inhibition of gastric acid secretion it may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, ampicillin esters, iron salts, digoxin). Patients may require titration of their theophylline dosage when lansoprazole is started or stopped to ensure clinically effective blood levels.

Contraindications/Precautions: Contraindicated in patients with known hypersensitivity to any component of the formulation. Pregnancy Category B.

Adverse Effects: Diarrhea, abdominal pain, nausea, and headache.

Patient Consultation:

Take on an empty stomach one hour before a meal.

The capsules should be swallowed whole, or the contents sprinkled onto soft food and swallowed without chewing.

Store in a cool, dry place away from sunlight and children.

Contact a physician if the above side effects are severe or persistent.

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According to the findings of a recent study, the popular class of heartburn drugs called proton pump inhibitors (PPIs) may inhibit vascular cells in a way that causes them to age prematurely, which may explain the harmful side effects that have been linked to Nexium, Prilosec and other proton pump inhibitors. If you took a proton pump inhibitor like Nexium, Prilosec, Prevacid or Protonix, and you have since suffered kidney damage, dementia, bone fractures, or another major side effect, you may have grounds to file a PPI injury lawsuit against the drug manufacturing company. Consult a reputable product liability lawyer today to explore your possible compensation options.

What are Proton Pump Inhibitors?

Nexium, Prilosec and Prevacid belong to a class of drugs known as proton pump inhibitors, which are designed to relieve the symptoms of heartburn and acid reflux by reducing the amount of gastric acid produced in the stomach. Because Nexium and other PPI drugs are believed to carry a low risk of side effects, many patients remain on the medications for years, with no attempt to reduce or discontinue use. However, a number of studies published in recent years have identified a potential link between proton pump inhibitors and devastating side effects like kidney damage, chronic kidney disease, end-stage kidney failure, dementia, bone fractures and cardiovascular problems.

Adverse Effects of PPI Drugs

In a study published online by the American Heart Association’s Circulation Research journal in May, researchers from the Houston Methodist Research Institute looked at the long-term effects of proton pump inhibitors like Nexium and Prilosec, which are used by millions of Americans experiencing persistent heartburn and acid reflux. According to the study findings, the active ingredient in Nexium, esomeprazole, adversely affected human cells in a number of ways, impairing endothelial function, affecting the inner lining of blood cells, and prematurely aging the cells. “In the presence of consistent epidemiological evidence of harm, […] and with the knowledge that PPIs are being used by millions of people for indications and durations that were never tested or approved, it is time for the pharmaceutical industry and regulatory agencies to re-visit the specificity and the safety of these agents,” the researchers wrote.

This isn’t the first study to examine the adverse effects of proton pump inhibitors on human health. Earlier this year, research published in the medical journal JAMA Internal Medicine found that users of Nexium, Prilosec, Prevacid, and other PPI drugs faced a 50% increased risk of chronic kidney disease, compared to non-users. In another study published in May, researchers from the Department of Veterans Affairs concluded that patients taking the heartburn drugs were 96% more likely to suffer kidney failure, and 28% more likely to suffer chronic kidney disease after five years of use.

Lawsuits Filed Over Heartburn Drug Injuries

With this information in mind, a growing number of patients who have experienced adverse effects of proton pump inhibitors are filing product liability lawsuits against the makers of Nexium, Prilosec, Prevacid and other PPIs, accusing the companies of negligence and failure to warn. Plaintiffs involved in the proton pump inhibitor litigation allege that the drug manufacturing companies put their desire for profits before patient safety, and say that if warnings had been provided about the risk of kidney failure and other side effects of the heartburn drugs, they never would have taken the medications in the first place.

An Experienced PPI Injury Lawyer Can Help

As product liability lawyers across the country continue to review and file PPI injury complaints, it is estimated that thousands of cases could be filed in the coming months. If you believe you have been adversely affected by side effects of Nexium, Prilosec, or another proton pump inhibitor, contact an experienced product liability lawyer today to discuss your legal options. You may be entitled to financial compensation for your injuries, past and future medical bills, lost wages, and other damages, which you can pursue by filing a personal injury lawsuit against the drug manufacturing company.

Additional Information & Resources for PPI Patients

American Heart Association’s Circulation Research – Long-term effect of PPIs

Monroe Law Group – This law firm that accepts Nexium cases.