Proton Pump Inhibitors: Dangerous and Habit-Forming Heartburn Drugs
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Health Letter SIDNEY M. WOLFE, M.D., EDITOR SEPTEMBER 2011 – VOL. 27, N o. 9 Proton Pump Inhibitors: Dangerous and Habit-Forming Heartburn Drugs obert Kuttner, co-editor of The PPIs Available in the U.S. a documented need for the therapy, and American Prospect magazine, many more could easily be switched to R Prescription PPIs had experienced a few bouts of mild safer options. heartburn, when a particularly severe Generic Name Brand Name episode sent him to the emergency dexlansoprazole Dexilant PPIs available in the U.S. room. After his doctor prescribed esomeprazole Nexium There are currently eight different Prilosec (omeprazole), a common esomeprazole and prescription PPI medications and three Vimovo* heartburn therapy, he thought that this naproxen over-the-counter medications available would resolve his condition. He never lansoprazole Prevacid on the U.S. market. (See the “PPIs imagined that this drug — intended to omeprazole Prilosec Available in the U.S.” table on this treat his symptoms — would actually omeprazole and page.) Zegerid make them worse, and that he would sodium bicarbonate Some of the FDA-approved uses become dependent for years on ever- pantoprazole Protonix for prescription PPIs are treatment of increasing doses of the medication in rabeprazole Aciphex gastric ulcers and erosive esophagitis, a dangerous cycle ending only after he and prevention of upper gastrointestinal Over the Counter PPIs stopped taking Prilosec and switched to bleeding, commonly seen with other, safer therapies. Generic Name Brand Name nonsteroidal anti-inflammatory drug This story is likely all too common omeprazole Prilosec OTC (NSAID) use. One of the most common among patients placed on a widely used omeprazole and Zegerid OTC conditions for which PPIs are prescribed class of medications known as proton sodium bicarbonate is gastroesophageal reflux disease pump inhibitors (PPIs) — Prilosec lansoprazole Prevacid 24-Hr (GERD), or heartburn. being the most common — which Many people have experienced * Vimovo is a combination of the PPI suppress stomach acid and are used to esomeprazole and the nonsteroidal anti- GERD at some point in their lives, and treat conditions such as heartburn and inflammatory drug (NSAID) naproxen. for some, it is so severe that they seek other, more severe illnesses. The drugs out, and often need, medication for have traditionally been considered petition, visit: http://www.citizen.org/ relief. But, for most, the symptoms are largely harmless by patients and petition-asking-fda-to-add-warnings- mild and fluctuate with lifestyle or diet, physicians alike. Yet PPIs have been to-ppis.) The petition was supported by and minor modifications to either could increasingly associated with a range of Mr. Kuttner and Dr. Helge Waldum, alleviate symptoms. Yet studies show dangerous, and sometimes fatal, side a physician-researcher and author of that many of these people are placed on effects and can even cause, as in Mr. 135 scientific papers, among them the PPIs unnecessarily — and once they’re Kuttner’s case, long-term dependence. first study showing that patients could see PPI, page 2 In August 2011, Public Citizen filed become dependent on PPIs. a petition with the Food and Drug The absence of prominently displayed Administration (FDA) to put black box risk information in PPI labels is likely a In This Issue warnings on all PPIs to warn doctors key contributor to the vast amount of and patients of these life-threatening overuse of the drugs, as doctors may Preventing Diabetes side effects and to remind doctors that not be aware that such serious risks exist on a Budget ........................................ 6 there are many safer alternatives for and thus resort to PPIs as a first option RECALLS ............................................ 8 everyday conditions, such as acid reflux, for even mild cases of heartburn. Most OUTRAGE! ......................................... 12 that often work just as well. (To read the patients on the drugs do not even have For more health-related news, visit our website at www.citizen.org/hrg PPI, from page 1 Nexium amid a large-scale promotional on, they may have a hard time getting campaign, with a half-billion dollars off the drugs. spent on marketing in just the first year. In response, sales predictably climbed to PUBLIC CITIZEN History and popularity astronomical levels. By 2009, Nexium of PPIs was easily the top-selling PPI and Health Letter ranked second in both retail sales ($5 PPIs first emerged on the scene in billion) and number of prescriptions SEPTEMBER 2011 the 1980s, at a time when patients filled (26.5 million) among all brand- Vol. 27, No. 9 often medicated for heartburn on an name drugs in the country. as-needed basis, using safe antacid This trend of repackaging older Editor therapies or modifying their daily PPIs in slightly modified (and much Sidney M. Wolfe, M.D. routines in ways that often worked to more expensive) forms continued relieve symptoms, such as raising the with the recent approval of Dexilant head of the bed or avoiding certain Managing Editor (dexlansoprazole — a repackaging of foods in excess. The need for long-term, Cynthia Williams Prevacid, or lansoprazole, which is now once-daily acid-suppressing therapy was available as a generic and much cheaper). relatively uncommon and reserved for Nexium and Dexilant are prime Contributors severe cases of acid reflux. Histamine-2 Sidney M. Wolfe, M.D. examples of the decreased innovation receptor antagonists (H2As) — such as seen in the pharmaceutical industry in Sammy Almashat, M.D. cimetidine (Tagamet) and ranitidine recent years, and of the desperate — (Zantac) — were the drugs of choice and wildly successful — attempts of Graphic Designer for quelling excessive acid production Erin Hyland the industry to get doctors to prescribe, in these cases. These drugs work by and patients to use, exorbitantly priced suppressing acid production in the drugs that are essentially identical to Public Citizen President stomach, but not as profoundly as do older, cheaper versions. Robert Weissman PPIs. They, therefore, carry a lower risk for serious adverse effects. Relief at a high cost However, following their intro- The Health Research Group was co- Due in large part to these duction in the U.S., PPIs rapidly rose founded in 1971 by Ralph Nader and promotional campaigns, PPI sales have in popularity over the next two decades. Sidney Wolfe in Washington, D.C., skyrocketed. But what are the costs This was due in part to their considerable to fight for the public’s health and of such widespread use? And do these effectiveness for certain serious give consumers more control over costs outweigh the benefits? conditions, such as peptic ulcer disease, decisions that affect their health. The economic cost of PPI use is high but much more so to their widespread enough, with $13.6 billion spent on the inappropriate use for indications for Annual subscription rate is drugs in one year alone (2009), making which there is no evidence of benefit $18.00 (12 issues). them the third highest-selling class of and their (incorrectly) perceived lack drugs in the country. By contrast, safer of side effects. PPI use increased more Material in the Health Letter may not H2A therapies are not even among than eight-fold from 1995 to 2006, be reprinted without permission from the 15 top-selling drug classes, not to and in 2009, there were 119 million mention the lower prices of antacids the Editor. Send requests, subscrip- prescriptions filled for the medications. and the safest of all options: diet and tion and address changes to: Contributing to this explosion in lifestyle changes. PPI use were massive promotional Unfortunately, this higher spending Health Letter campaigns and a disturbing trend of on PPIs does not confer any increase 1600 20th St. NW older PPIs being repackaged in new, in safety or, in most cases, effectiveness. Washington, DC 20009 slightly tweaked but otherwise identical As discussed below, most people with forms. Nexium (esomeprazole) is a heartburn can do just fine using safer Copyright © Health Letter, 2011 poster child of this trend. Nexium, the alternatives. Moreover, PPIs have Published monthly by Public Citizen’s so-called “purple pill,” was simply a serious safety issues not seen with other Health Research Group reformulation of a previously approved heartburn therapies. Of most concern drug, Prilosec (omeprazole), whose All rights reserved. ISSN 0882-598X to patients contemplating PPI therapy, patent was expiring around the time of due to the absence of prominent Nexium’s introduction. In 2001, drug manufacturer AstraZeneca released see PPI, page 3 2 ✦ September 2011 PPI, from page 2 In August 2011, Public Citizen filed a petition with warnings in the drugs’ labels, even the FDA to put black box warnings on all PPIs [such doctors may not be aware of these potentially fatal side effects prior to as Prilosec] to warn doctors and patients of … life- writing a prescription. threatening side effects and to remind doctors that there Furthermore, new side effects are are many safer alternatives for everyday conditions, constantly being found. In just the past such as acid reflux, that often work just as well. year and a half, the FDA has released two safety alerts warning that PPI use include safety information warning deficiency. Magnesium is an was associated with potentially fatal patients about the risk of hip, essential electrolyte, and a decrease side effects: osteoporotic fractures (of spine and wrist fractures after in levels can be life-threatening, the hip, spine and wrist) and severe using PPIs for a year or more. causing dangerous heart-rhythm magnesium deficiency. These are This announcement came after disorders and seizures. Certain two of many serious adverse reactions a review by the FDA of seven patients, especially the elderly, that have been associated with PPI large studies showing that the may be taking other medicines that therapy, as detailed in our petition and drugs were linked with a higher decrease magnesium levels (such as summarized below.