If you’re one of the more than 60 million Americans with gastro-esophageal reflux disease, or GERD, you’re probably very familiar with the pain and discomfort of heartburn, dyspepsia (stomach discomfort), and regurgitation that is so typical of the condition. Although the symptoms are rarely considered serious, they cause enough distress that many people constantly reach for OTC antacids or prescription medications for relief. It’s the prevalent use of the latter that has caught the attention of Public Citizen, a consumer advocacy watchdog group.
Recently Public Citizen filed a petition urging the FDA to require stricter warnings on popular drugs known as proton pump inhibitors used to treat acid reflux. They’re seeking the strongest warning possible – a “black box” warning – that would warn consumers of their potential to cause dependency as well as a detailed list of side effects.
Why the concern?
According to Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, “These drugs have a use, but they’re grossly overused. We hope use will go down when doctors and patients know the risks.” Though some of the risks, which include infections, heart rhythm disruption and bone fractures, are already listed, one risk is excluded. That is the potential for the drugs to make the reflux worse once the patient stops taking the drug. Since this is a recent observation, the watchdog group feels the public should be made aware through the packaging details.
Wolfe says, “There’s absolutely no warning that these drugs can cause dependence.” Perhaps if the information was readily apparent, both patients and doctors would consider other options before going straight for the medication. Protonix and Nexium, as well as generic versions of proton pump inhibitors, are approved for conditions such as GERD, heartburn, and gastric ulcers. However, a study published in the journal Alimentary Pharmacology and Therapeutics revealed that as much as two-thirds of patients using the drug don’t meet the criteria for use.
This is troubling, especially when simple treatments can sometimes offer soothing relief. And even more troubling is the possible risk of dependence of the drug. Wolf said, “Since over half the people using these drugs don’t even have conditions that warrant their use, you’re essentially causing acid reflux disease. We want doctors to know that, for some patients, these drugs are possibly causing more harm than good.”
Apparently, this message is something doctors need to know. Currently, proton pump inhibitors are the third highest-selling drugs in America. Nexium is the second highest sales among all drugs – to the tune of $4.8 billion in 2008.
Many believe part of the solution lies in education and lifestyle changes that can have a positive effect on the bothersome symptoms. Such changes include weight loss, smoking cessation, and avoiding foods known to exacerbate the problem such as coffee, carbonated beverages, onions, and garlic.