GERD Drugs Dangerous, Habit-Forming Says Public Citizen to FDA

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If you take one of the numerous drugs for GERD (gastroesophageal reflux disease), you may want to heed the statements made by Public Citizen, a nationwide public advocacy group. The group has petitioned the FDA to place a warning label on these drugs because it says they are dangerous and habit-forming.

Five percent of people worldwide take GERD drugs

Drugs for GERD, erosive esophagitis, and gastric ulcers are known as proton pump inhibitors (PPIs), but you may know them as Aciphex, Dexilant, Nexium, Prevacid, Prilosec, and Zegerid, among others (generics esomeprazole, omeprazole, lansoprazole). They were prescribed to the tune of $13.6 billion in the United States alone in 2009, and Public Citizen would like people to know these drugs may do much more than inhibit production of stomach acid.

Evidence of the dangers of PPIs has been around for several years. In 2009, Reimer et al proposed that the drugs could cause or aggravate the disease process itself when the researchers found that 40 percent of previously healthy volunteers experienced acid reflux or heartburn after they stopped a two-month course of esomeprazole.

This is a condition known as rebound acid hypersecretion. If you are familiar with the term rebound headache, the concept is the same. In this case, people who stop taking a GERD drug produce more stomach acid after stopping the drug than they did before they ever took it. This excessive acid causes the symptoms to return at a greater intensity, and so patients start taking the drug again, and the vicious cycle has begun.

While this set-up for long-term dependence on the drugs is of great concern for anyone prescribed the medication, it is especially a problem for people who never needed the drugs at all. “These drugs are being prescribed far too commonly to people who shouldn’t be taking them,” noted Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.

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In fact, studies indicate that up to two-thirds of people who are taking PPIs do not have a condition for which these drugs were designed. Most people prescribed GERD drugs also take them for much longer than the 8 to 12 weeks for which they are approved, although doctors can extend the treatment time. However, many people take the drugs for months, even years.

In the Public Citizen’s news release, Wolfe explained that the overprescription of GERD drugs means that “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.” Thus Public Citizen has petitioned the FDA to place warning labels on the drugs to let people know about the dangers.

Dependency is not the only hazard associated with GERD medications. Use of proton pump inhibitors also increases a person’s risk of severe magnesium deficiency (which can cause cardiac arrhythmias), vitamin B12 deficiency, serious infections such as pneumonia and C. difficile diarrhea, kidney failure, and fractures of the hip, spine, and wrist. PPIs may also reduce the effectiveness of drugs used to treat cancer and heart attack.

In a 2009 article published in Gastroenterology entitled “Evidence that proton-pump inhibitor therapy induces the symptoms it is used to treat,” the authors noted that “Patients often ask about the safety and likelihood of side effects from proton-pump inhibitory therapy.” They advised that “Now that rebound acid secretion has been demonstrated to induce symptoms, we are probably obliged to inform them about rebound acid hypersecretion and its potential effects.”

The Public Citizen would like the FDA to do just that: let the public know that GERD drugs are dangerous and habit-forming. This knowledge may prompt patients and physicians to seek alternatives to treat the symptoms.

SOURCES:
McColl KEL, Gillen D. Gastroenterology 2009; 137(1): 20-22
Public Citizen
Reimer C et al. Gastroenterology 2009; 137(1): 80-87

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Comments

Another article on this site discussed a study on how plantain consumption could help with Crohn's disease. For this article, it would be interesting to know if any research has been done on alternative diets for ulcers and other digestive problems.