Many widely prescribed stomach acid-reducing drugs can cause long-term dependence and should carry the strongest possible warning label, Public Citizen told the U.S. Food and Drug Administration (FDA) in a petition sent today.
The drugs are proton pump inhibitors (PPIs), so-called because of the mechanism they use to shut off the production of stomach acid.
PPIs are one of the most widely used classes of drugs in the United States, with 119 million prescriptions dispensed in 2009 and $13.6 billion in U.S. sales. An estimated 1 of every 20 people in the developed world is taking the medications, which include Nexium, Dexilant, Prilosec, Prilosec OTC, Zegerid, Zegerid OTC, Prevacid, Prevacid 24-Hr, Protonix, Aciphex, Vimovo and numerous generic counterparts, most prominently omeprazole and pantoprazole.
“These drugs are being prescribed far too commonly to people who shouldn’t be taking them,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “As a result, millions of people are needlessly setting themselves up to become dependent on PPIs while exposing themselves to the serious risks associated with long-term therapy."
"The FDA should act immediately to ensure that patients and physicians are adequately warned of these effects, and reminded of the many safer alternatives for common conditions such as acid reflux,” Wolfe said.
PPIs are approved to treat gastroesophageal reflux disease (GERD) – sometimes referred to as acid reflux – as well as gastric ulcers, erosive esophagitis and stomach bleeding associated with using non-steroidal anti-inflammatory drugs (NSAIDs).
But evidence shows that after using PPIs for a month or more, patients who stop taking the drug make even more stomach acid than before they started the drug, a phenomenon known as rebound acid hypersecretion, which causes acid reflux symptoms to return even worse than before therapy.
The symptoms prompt patients to begin taking the PPI again, creating a long-term dependence on these drugs, particularly worrisome for the large number of patients who did not even need the drugs in the first place.
As Dr. K.E. McColl, a leading Scottish researcher on adverse effects of PPI use, recently concluded, “The current finding that these drugs induce symptoms [after withdrawal] means that such liberal [mis-] prescribing is likely to be creating the disease the drugs are designed to treat and causing patients with no previous need for such therapy to require intermittent or long-term treatment.”
In addition to creating dependency, PPIs increase the risk for several serious conditions, including fractures of the hip, spine and wrist; an increased risk of serious infections such as pneumonia and C. difficile diarrhea; and severe magnesium deficiency, which can cause life-threatening cardiac arrhythmias.
PPIs also may reduce the effectiveness of other drugs used to treat heart attacks and cancer, and in some cases, can cause vitamin B12 deficiency and kidney failure. Although some of these side effects already are mentioned somewhere in the labels (not the case for the dependence), none – including those that are life-threatening – are displayed prominently as black box warnings, the strongest possible warning.
Therefore, physicians may not be aware of the serious risks associated with PPI therapy, resulting in a large number of unnecessary prescriptions. Studies have shown that up to two-thirds of all people taking PPIs do not even have a condition that the drugs are designed to treat,and the drugs are often taken for much longer periods of time than they are approved for.
In addition, PPIs are commonly prescribed for conditions such as acid reflux that could be treated with safer alternatives that are often just as effective.