Aciphex over the counter

Rabeprazole

Generic Name: rabeprazole (ra BEP ra zole)
Brand Name: AcipHex, AcipHex Sprinkle

Medically reviewed by Drugs.com on Jun 25, 2018 – Written by Cerner Multum

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What is rabeprazole?

Rabeprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

Rabeprazole is used short-term to treat symptoms of gastroesophageal reflux disease (GERD) in adults and children who are at least 1 year old.

Rabeprazole is used only in adults to treat conditions involving excessive stomach acid, such as Zollinger-Ellison syndrome. Rabeprazole is also used in adults to promote healing of duodenal ulcers or erosive esophagitis (damage to your esophagus caused by stomach acid).

Rabeprazole may also be given with an antibiotic to prevent duodenal ulcer caused by infection with Helicobacter pylori (H. pylori).

Rabeprazole is not for immediate relief of heartburn symptoms.

Rabeprazole may also be used for purposes not listed in this medication guide.

Important Information

Rabeprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Rabeprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking rabeprazole long term or more than once per day.

Before taking this medicine

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel anxious or light-headed.

You should not use this medicine if you are allergic to rabeprazole or:

  • if you also take any medicine that contains rilpivirine, such as Edurant or Complera; or

  • if you are also allergic to medicines like rabeprazole, such as esomeprazole, lansoprazole, omeprazole, pantoprazole , Nexium, Prevacid, Prilosec, Protonix, and others.

Tell your doctor if you have ever had:

  • liver disease;

  • osteoporosis or low bone mineral density (osteopenia);

  • lupus (an autoimmune disorder); or

  • low levels of magnesium in your blood.

You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Do not give this medicine to a child without medical advice. Certain forms and strengths of rabeprazole should not be given to a child younger than 12 years old.

How should I take rabeprazole?

Rabeprazole is usually taken once per day. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Rabeprazole is for short-term use only, usually 4 to 8 weeks. Your doctor may recommend a second course of treatment if you need additional healing time.

AcipHex Sprinkle should not be given to a child younger than 1 year old.

Take rabeprazole with a full glass of water.

If you take rabeprazole to treat duodenal ulcers, take the medicine after a meal. If you take rabeprazole to prevent ulcers caused by Helicobacter pylori, take the medicine with food. If you take rabeprazole for any other condition, you may take the medicine with or without food.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Swallow the tablet whole and do not crush, chew, or break it.

Do not swallow a delayed-release capsule (AcipHex Sprinkle) whole. Open it and sprinkle the medicine into a spoonful of soft food such as applesauce, yogurt, or baby food made from fruit or vegetable. You may also mix the medicine with apple juice, Pedialyte, or infant formula. Swallow the mixture right away without chewing. Do not save it for later use.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using rabeprazole.

Some conditions are treated with a combination of rabeprazole and antibiotics. Use all medications as directed.

Take your medicines for the full prescribed length of time, even if your symptoms quickly improve.

Call your doctor if your symptoms do not improve, or if they get worse while using rabeprazole.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking rabeprazole?

rabeprazole can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Rabeprazole side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;

  • sudden pain or trouble moving your hip, wrist, or back;

  • seizure (convulsions);

  • kidney problems–urinating less than usual, blood in your urine, swelling, rapid weight gain;

  • new or worsening symptoms of lupus–joint pain, and a skin rash on your cheeks or arms that worsens in sunlight;

  • low magnesium–dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or

  • signs of bleeding (if you also take warfarin)–headaches, dizziness, weakness; pain or swelling; bruising, unusual bleeding (nosebleeds, bleeding gums); red or pink urine; heavy menstrual flow; bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or any bleeding that will not stop.

Taking rabeprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use rabeprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

  • headache;

  • nausea, vomiting;

  • diarrhea, constipation; or

  • stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect rabeprazole?

Tell your doctor about all your current medicines. Many drugs can affect rabeprazole, especially:

  • digoxin;

  • methotrexate; or

  • warfarin (Coumadin, Jantoven).

This list is not complete and many other drugs may affect rabeprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 11.03.

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More about rabeprazole

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Consumer resources

  • Rabeprazole Delayed-Release Tablets
  • Rabeprazole Sprinkle Capsules
  • Rabeprazole (Advanced Reading)

Other brands: Aciphex, Aciphex Sprinkle

Professional resources

  • Rabeprazole Sodium (AHFS Monograph)
  • … +3 more

Related treatment guides

  • Barrett’s Esophagus
  • Duodenal Ulcer
  • Duodenal Ulcer Prophylaxis
  • Erosive Esophagitis
  • … +4 more

Global Journal of Digestive Diseases is an open access journal and print the articles after a thorough peer review. This journal is engaged with original research articles, practice forums, comprehensive review articles and news about scientific developments on digestive diseases includes, abdominal adhesions, acid indigestion, Alagille syndrome, anal fissure, appendicitis, autoimmune hepatitis, Barrett’s esophagus, barium enema, biliary atresia, celiac disease, chronic diarrhea, cirrhosis, colitis, colon polyps, colonic atresia, constipation, Crohn’s disease, dermatitis herpetiformis, Diarrhea, duodenal ulcers, dysentery, dyspepsia, esophageal cancer, Flatulence, gastritis, GERD, H. pylori and peptic ulcers, hiatal hernia, Menetrier’s disease, pancreatitis, piles, traveler’s diarrhea and ulcerative colitis etc.
Open access is an innovative platform, in which all the articles are projected in online in this journal and anyone can access it, in the world with completely free of cost. The main aim of this journal is to provide the readers, scholars and scientists to explore the knowledge in medical research of the digestive system. It is involved in various supporting tasks like commentaries, panel discussions on research articles and conferences.

Submit manuscript as an e-mail attachment to the Editorial Office at

Gastric Cancer

Stomach Cancer, otherwise called Gastric cancer, is tumor, creating from the coating of the stomach. Early side effects may incorporate acid reflux, upper stomach agony, queasiness and loss of hunger. Later signs and side effects may incorporate weight reduction, yellow skin, spewing, trouble gulping, and blood in the stool among others. The disease may spread from the stomach to different parts of the body, especially the liver, lungs, bones, covering of the belly and lymph nodes.The most regular reason is contamination by the bacterium Helicobacter pylori, which represents more than 60% of cases.

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Journal of the Pancreas, International Journal of Collaborative Research on Internal Medicine & Public Health, Archives in Cancer Research, International Journal of Applied Biology and Pharmaceutical Technology, Journal of Gastric Cancer, Journal of Gastrointestinal Oncology, Annals of Oncology, Translational Gastrointestinal cancer Journal of Institute of Medicine

Coeliac Disease

Coeliac disease is an autoimmune condition where the Immune system mistakenly attacks healthy tissue. The Immune system react abnormally to gluten (a protein found in wheat, rye, barley and oats), causing small bowel damage. A number of serious health consequences can result if the condition is not diagnosed and treated properly.

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International Journal of Collaborative Research on Internal Medicine & Public Health, Translational Biomedicine, International Journal of Drug Development and Research, Health Science Journal, International Journal of Celiac Disease, The American Journal of Gastroenterology, Journal of pediatric Gastroenterology and Nutrition, United European Gastroenterology Journal, The American Society for Clinical Pathology, The Pharmaceutical Journal

Constipation

Constipation is a condition in which you typically have fewer than three bowel movements a week and bowel movements with stools that are hard, dry, and small, making them painful or difficult to pass. The frequency of bowel movement, among healthy people, varies greatly ranging from three movements a day to three times a week. If more than three days pass without bowel movement the condition gains clinical significance. During such time, the intestinal contents may harden, and a person may experience difficulty or even pain during defecation.

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International Journal of Drug Development and Research, International Journal of Collaborative Research on Internal Medicine & Public Health, International Journal of Applied Biology and Pharmaceutical Technology, Journal of the Pancreas, Journal of the American Board of Family Medicine, The Pharmaceutical Journal British Journal of Anaesthesia, Digestive and Liver Disease, Canadian Medical Association Journal, Canadian Journal of Gastroenterology, World Journal of Gastroenterology, Gastroenterology Research and Practice

Diverticulosis & Diverticulitis

Diverticulosis is the formation of numerous tiny pockets, or diverticula, in the lining of bowel. Diverticula, which can range from pea-size to much larger, are formed by increased pressure on weakened spots of the intestinal walls by gas, waste, or liquid. Diverticula can form while straining during a bowel movement, such as with constipation. They are most common in the lower portion of the large intestine (called the sigmoid colon).

Diverticulitis is a condition where a diverticulum ruptures and infection sets in around the diverticulum. Symptoms include abdominal pain, abdominal tenderness, colonic obstruction and fever.

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Cirrhosis

Cirrhosis is a late stage of scarring (fibrosis) of the liver caused by many forms of liver diseases and conditions, such as hepatitis C, fatty liver and chronic alcohol abuse. It is a slowly progressing disease in which healthy liver tissue is replaced with scar tissue, eventually preventing the liver from functioning properly.

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Colon Polyps

Colony polyps are growths on the inner lining of the colon and are very common. Changes in the genetic material of cells lining the colon are cause of polyp formation. Colon polyps are important because they may be, or may become malignant (cancerous).

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Rectal Bleeding

Rectal bleeding is a symptom of a problem rather than a disease itself. Bleeding can come from one or more parts of digestive system. Blood that results from rectal bleeding can range in colour from bright red to dark maroon to a dark, tarry colour.

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Colorectal Cancer: Open Access, Journal of the Pancreas, International Journal of Drug Development and Research, International Journal of Applied Biology and Pharmaceutical Technology, American Journal of Gastroenterology, Journal of General Internal Medicine, Journal of pediatric Gastroenterology and Nutrition, Open Journal of Gastroenterology, World Journal of Emergency Surgery, Rawal Medical Journal, Medical Journal of Babylon, Journal of Pediatric Surgery, International Journal of Radiation Oncology

GERD (gastroesophageal reflux)

GERD is a condition in which the acidified liquid content of the stomach backs up into the esophagus. GERD may damage the lining of esophagus, thereby causing inflammation (esophagitis) although this is uncommon.

Related Journals of GERD

Journal of the Pancreas, International Journal of Drug Development and Research, International Journal of Applied Biology and Pharmaceutical Technology, Translational Biomedicine, American Journal of Gastroenterology, The Journal of the American Medical Association, World Journal of Gastroenterology, Gastroenterology Research and Practice, International Journal of Epidemiology

Barrett’s Oesophagus

Barrett’s esophagus is a condition in which tissue that is similar to the lining of intestine replaces with the tissue lining your esophagus.

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International Journal of Applied Biology and Pharmaceutical Technology, Quality in Primary Care, Journal of the Pancreas, Mental Health in Family Medicine,Journal of Cancer National Institute, The New England Journal of Medicine, Journal of Gastrointestinal Oncology, Pathology Research International, British Journal of Medical Practitioners, American Journal of Nursing

Haemorrhoids

Haemorrhoids are also known as piles. Haemorrhoids are swollen veins in the anal cavity.

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International Journal of Collaborative Research on Internal Medicine & Public Health, Journal of the Pancreas, Quality in Primary Care, Journal of Biomedical Sciences, World Journal of Gastroenterology, The American Journal of Gastroenterology, Clinical Gastroenterology and Hepatology, The New England Journal of Medicine, Journal of the American Academy of Physician Assistants, Journal of American Medical Association

Portal Hypertension

Portal hypertension is an increase in the blood pressure within a system of veins called the portal venous system. It occurs when there is an obstruction of blood flow through the liver and pressure rises within the portal vein.

Related Journals of Portal Hypertension

Journal of the Pancreas, Journal of Biomedical Sciences, International Journal of Collaborative Research on Internal Medicine & Public Health, International Journal of Drug Development and Research, Journal of Hepatology, International Journal of Hepatology, Journal of Veterinary Internal Medicine, World Journal of Gastroenterology, American Journal of Roentgenology, European Journal of Gastroenterology & Hepatology, Journal of Clinical and Experimental Hepatology, Clinical Infectious Diseases, Journal of the American college of Surgeons

Esophageal Varices

Esophageal varices are abnormal, enlarged veins in the lower part of the esophagus- the tube that connects the throat and stomach. Esophageal varices occur most often in people with serious liver diseases.

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Archives of Medicine, Health Science Journal, Journal of the Pancreas, Quality in Primary Care,The New England Journal of Medicine, International Journal of Hepatology, American Journal of Nursing, American Journal of Roentgenology, Saudi Journal of Gastroenterology, The American Journal of Gastroenterology, World ournal of Surgery, The Japanese journal of surgery, Rawal Medical Journal, Journal of Hepatology

Crohn’s Disease

Crohn’s disease is an inflammatory bowel disease results in inflammation of the lining of digestive tract. Inflammation can involve different areas of the digestive tract in different people. This inflammation leads to abdominal pain, fatigue, diarrhoea, weight loss and malnutrition.

Related Journals of Crohn’s Disease

Journal of the Pancreas, Quality in Primary Care, Health Science Journal, International Journal of Drug Development and Research, Inflammatory Bowel Diseases Journal, Journal of Crohn’s and Colitis, The New England Journal of Medicine, The American Journal of Gastroenterology, Clinical Gastroenterology and Hepatology, Nutrition Journal, Scandinavian Journal of Gastroenterology

Peritonitis

Peritonitis is caused by infection from bacteria or fungi which results in the inflammation of peritoneum. Peritoneum is the tissue that lines the inner wall of the abdomen and covers and supports most of your abdominal organs.

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International Journal of Collaborative Research on Internal Medicine & Public Health, International Journal of Applied Biology and Pharmaceutical Technology, Journal of the Pancreas, Health Science Journal, World Journal of Emergency Surgery, Journal of Pediatric Surgery, Clinical Journal of the American Society of Nephrology, European Journal of Medical Research, Journal of Hepatology, Postgraduate Medical Journal, The American Journal of Gastroenterology, The Veterinary Journal, International Journal of Biomedical Research

Ulcer

An ulcer is a wound in the lining of the stomach or duodenum, but really any part of the gastrointestinal tract can ulcerate.

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International Journal of Drug Development and Research, Translational Biomedicine, International Journal of Collaborative Research on Internal Medicine & Public Health, Quality in Primary Care, Ulcers Journal, The Journal of the American Medical Association, American Journal of Epidemiology, American Journal of Critical Care, American Meterological Society, Journal of Thoracic Oncology, Journal of Wound, Ostomy and Continence Nursing

Hernias

Hernias are most common in the abdomen and occurs when an organ pushes through an opening in the muscle or tissue that holds it in place.

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International Journal of Collaborative Research on Internal Medicine & Public Health, Archives in Cancer Research, Journal of the Pancreas, Journal of Biomedical Sciences, The World Journal of Hernia and Abdominal Wall Surgery, World Journal of Emergency Surgery, The Journal of the American Medical Association, Journal of Surgical Case Reports, Journal of Surgical Research, American Journal of Roentgenology

Questions and Answers about PPIs

Question What are the differences between the proton pump inhibitors? Do they all have the same side effect profile? If I experience side effects from one, will I experience the same effects if I try another? Answer

By: J. Patrick Waring, MD, a gastroenterologist at Digestive Healthcare of Georgia, Piedmont Hospital, Atlanta, GA

Proton pump inhibitors (PPIs) are the most commonly prescribed class of medication for the treatment of heartburn and acid-related disorders. They work by blocking the site of acid production in the parietal cell of the stomach.

Because there are millions of parietal cells that are constantly reproducing, complete inhibition of stomach acid production is virtually impossible. This probably explains the tremendous safety of these medications.

However, side effects can occur, and some people are at increased risk for adverse events (see below).

There are a number of PPIs available in the United States and more are in development. The medications are structurally and chemically similar. There are relatively few comparisons of these drugs with each other.

All the medications heal esophagitis in 90–94% of patients. There are no significant differences in overall healing and symptom improvement rates between the medications.

Omeprazole (Prilosec) and lansoprazole (Prevacid) have been available the longest and consequently are the most familiar to physicians and patients. Omeprazole and lansoprazole are now available over-the-counter.

While the newer medications, rabeprazole (Aciphex) and pantoprazole (Protonix) have data to suggest better suppression of stomach acid compared to omeprazole, there is no proof that the differences are clinically important. Rabeprazole and pantoprazole are smaller and may be better for patients who have problems swallowing capsules. Pantoprazole is marketed as being cheaper, and may be better for patients paying for their own medications.

Esomeprazole (Nexium), a new and very potent PPI, was approved by the U.S. Food and Drug Administration (FDA) in 2001. Zegerid is a combination of omeprazole and sodium bicarbonate.

Dexlansoprazole (Dexilant) was FDA approved in 2009. Dexilant was originally known as Kapidex.

Information on side effects from studies where a PPI is compared to a placebo show that the most common side effects are headache, abdominal pain, bloating, diarrhea and nausea. They occur in 1-2% of patients given PPIs.

Interestingly, the incidence of these side effects is the same as when patients take the placebo. It is hard to compare side effect profiles between the medications, but there is no reason to believe that there are significant differences.

There is no scientific data to guide physicians on how to deal with the relatively few patients that have side effects from one of the PPIs. However, nearly all physicians have had the experience of switching from one PPI to another successfully.

If you are having side effects from a PPI, you will not necessarily develop the same side effects if you switch to another PPI. Discuss this option with your physician. The only exception may be in the extremely rare instance of severe allergic reactions.

Additional Safety Information

Source: U.S. Food and Drug Administration (FDA). Accessed 01/31/2012

  • Proton pump inhibitors are effective in treating a variety of gastrointestinal disorders. Do not stop taking your proton pump inhibitor unless told to do so by your healthcare professional.
  • Be aware that an increased risk of fractures of the hip, wrist, and spine has been reported in some studies of patients using proton pump inhibitors. The greatest increased risk for these fractures was seen in patients who receive high doses of these medications or use them longer (a year or more).
  • Read and follow the directions on the OTC Drug Facts label, when considering use of OTC proton pump inhibitors.
  • Be aware that the OTC proton pump inhibitors should only be used as directed for 14 days for the treatment of frequent heartburn. If your heartburn continues, talk to your healthcare professional. No more than three 14-day treatment courses should be used in one year.
  • Talk to your healthcare professional about any concerns you may have about using proton pump inhibitors.

Long-term PPI therapy safety study: Is there an increased risk of hip fracture?

A study published in JAMA (2006;296:2947-2953) was conducted to determine whether there is an association between long-term proton pump inhibitor (PPI) therapy and the risk of hip fracture. The study concluded that long-term PPI therapy, particularly at high doses, is associated with an increased risk of hip fracture.

Question
What does this study mean for people who benefit from taking a PPI?

Answer
By: J. Patrick Waring, MD, a gastroenterologist at Digestive Healthcare of Georgia, Piedmont Hospital, Atlanta, GA
Many patients were alarmed recently by news reports of a 44% increase in the risk of a hip fracture if they are taking a proton pump inhibitor (PPI). The currently available PPIs include:

This is the latest in a series of articles that have questioned the safety of these powerful, widely used medications. Worldwide, PPIs have been available for over 20 years.

In the 1980’s there were concerns that, by profoundly decreasing stomach acid production, they might lead to other health problems such as serious infections, poor absorption of vitamins and minerals, even gastrointestinal cancers. However, by the mid-1990s, based largely on anecdotal experience, it was becoming clear that PPIs were remarkably safe.

Formal studies looking at the use of PPIs in hundreds of patients showed virtually no long term side effects. As a result, new PPIs were developed, PPIs became generic and ultimately available over the counter without a prescription. This was a great advance in our ability to treat the millions of patients worldwide that have acid-peptic diseases.

In the last few years, researchers have been able to evaluate the side effects and complications of medications by using large databases of millions of patients.

A recent report in the Journal of the American Medical Association (JAMA) looked at the medical records of over 9 million people in the United Kingdom. They were able to identify over 13,000 people with a hip fracture and compare them to over 135,000 people who did not have a hip fracture. They found that using a PPI for over 1 year increased the risk of a hip fracture by 44%. They also found that the risk increased further if the patients were taking the PPI a longer period of time, or at higher doses. This is probably due to impaired calcium absorption when there is less acid in the stomach.

Now, it must be mentioned that the patients with hip fractures in this study were much more likely to be a cigarette smoker, be thin, be a diabetic, be alcoholic, have had a stroke, had dementia or had previous bone fractures.

Studies like this talk about the risk per patient-year of follow up. For example if one follows 100 patients for 10 years, that is 1,000 patient-years of follow-up. This study suggests that the risk of a hip fracture that is specifically related to PPI use is about 2 per 1,000 patient-years.

There have been other reports over the past couple of years about the possible risk of pneumonia and infections of the colon with a bacterium called clostridium difficile in patients taking PPIs. Again, these articles looked at the medical records of hundreds of thousands of patients and found a small increased risk in patients using PPIs. Additionally, like the hip fracture study, other medical illness such as diabetes, heart and lung disease were also important risk factors.

The Canadian Task Force for Preventative Health Care recently published recommendations for the prevention of osteoporosis in women. It mentioned major risk factors such as advanced age, family history of osteoporosis, early menopause, propensity to fall and minor risk factors such as being thin, smoking, excess alcohol or caffeine intake. We may learn that long term PPI use will be considered a minor risk factor.

If you need to take a PPI, you should talk with your doctor about your risk of osteoporosis. If you have other risk factors, you may need a bone density test. You may simply need to take exercise more or take calcium supplements. You may need to take one of the many excellent medicines for osteoporosis.

It has probably been wishful thinking that the long-term use of PPIs was perfectly safe. Like most medications, there are side-effects and complications. Fortunately the overall risk of long-term PPI use still seems to be relatively small.

Common sense tells that if you don’t need to take a PPI, you should talk to your doctor about stopping it. There any many people taking PPIs that could be using a less powerful medication. However, most people who need to take a PPI should be able to safely continue to take it without the fear of serious complications.

Reflux Symptoms Not Always GERD

A study of 106 individuals with typical reflux symptoms persisting despite treatment with proton pump inhibitors (PPIs), which limit acid secretion in the stomach, aimed to determine the underlying cause of reflux symptoms not responding to PPI therapy. The study found that approximately one-third of the patients suffer from disorders other than gastroesophageal reflux disease (GERD), predominantly functional heartburn, concluding that this explains, at least partly, why many patients will not benefit from acid inhibitory treatment.

Source: Herregods TVK, et al. Neurogastroenterol Motil. September 2015.

FDA Issues Warning on Acid Reflux Drugs

WEDNESDAY, Feb. 8, 2012 (MedPage Today) — The FDA warned today that use of proton pump inhibitors (PPIs) to treat gastroesophageal reflux disease (GERD) — including popular brands such as Nexium, Prilosec, and Prevacid — may increase the risk of Clostridium difficile-associated diarrhea, which is serious and may contain blood or pus.

The warning comes after a review of data from the agency’s Adverse Event Reporting System and the medical literature suggested such a link, and an analysis reported at the 2010 meeting of the American College of Gastroenterology yielded the same finding.

Many of the adverse cases involved patients who were elderly, had underlying medical conditions, or were taking broad spectrum antibiotics. All of those factors could have contributed to the greater risk of C. difficile-associated diarrhea, but the use of PPIs could not be excluded.

The FDA advised healthcare providers to consider a diagnosis of C. difficile-associated diarrhea if patients taking PPIs present with diarrhea that is not improving and said patients should take the lowest dose of PPI for the shortest time possible to improve the condition being treated.

The agency is working with the drug makers to modify the labels to include the possible risk of C. difficile-associated diarrhea.

The warning applies to the following PPIs, both prescription and over-the-counter:

  • rabeprazole sodium (AcipHex)
  • dexlansoprazole (Dexilant)
  • esomeprazole magnesium (Nexium)
  • omeprazole OTC
  • lansoprazole (Prevacid) and Prevacid 24hr OTC
  • omeprazole (Prilosec) and Prilosec OTC
  • pantoprazole sodium (Protonix)
  • esomeprazole magnesium and naproxen (Vimovo)
  • omeprazole and sodium bicarbonate (Zegerid) and Zegerid OTC

PPIs have been associated with other adverse events in the past, including resistance to clopidogrel (Plavix), low magnesium levels resulting in a greater risk of leg spasms, arrhythmias, and seizures, greater risk of osteoporotic fractures from chronic use, and cardiac birth defects when used during pregnancy.

The FDA is also reviewing the possible risk of in C. difficile-associated diarrhea in users of another class of acid suppressing medications, the histamine H2 receptor blockers.

“Saying they are the right treatment for heartburn is a little like saying that driving a Rolls-Royce to the supermarket is the best way to get there,” said Dr. Jerry Avorn, an internist at Brigham and Women’s Hospital, in Boston, who wrote “Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs.” “At current prices, it is wasteful and irrational for them to be the first thing that a patient or a doctor thinks of whenever they see a bellyache.”

Americans spent $13.5 billion on prescription P.P.I.’s in 2003, making them the second biggest-selling class of drugs, after cholesterol-lowering medicines, according to NDCHealth, a healthcare information company. The drugs are used to treat GERD (gastroesophageal reflux disease), whose chief symptom is recurring heartburn, and to heal the esophageal sores it can cause.

More than 60 million Americans suffer from GERD at least monthly, according to the National Institute of Diabetes and Digestive and Kidney Diseases. “These conditions are so common and the drugs are so safe that patients go through them like water,” said Dr. Nicholas Shaheen, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina.

Demand for proton pump inhibitors has been fueled by a barrage of advertisements. AstraZeneca, which makes Nexium, spent more than $110 million on television commercials for the “purple pill” last year, according The AARP Watchdog Report.

AstraZeneca also makes Prilosec, the best-selling prescription drug before it went over the counter less than two years ago. Chemically, the two drugs are distinct, but they keep stomach cells from producing acid in a similar manner. And doctors say they work equally well for a great majority of patients. “Unless your condition is very bad, you’re going to do pretty well on either drug,” Dr. Shaheen said.

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