But the watchdog group Public Citizen says the drugs — such as Nexium, Prilosec and Prevacid — are habit-forming and should carry the strongest possible warning label for this and other dangerous side effects. The group filed a petition Tuesday with the Food and Drug Administration asking them to add the warning.
In the petition, Public Citizen says the drugs, called proton pump inhibitors, are widely overprescribed and frequently used by people who don’t need them or who take them for too long.
PPIs work by reducing gastric acid production, which allows ulcers to heal and prevents excess stomach acid from leaking into the esophagus, damaging the tissue.
This “massive inappropriate use” of the drugs, the group says in its petition, has revealed serious safety problems with both short-term and long-term PPI use.
While side effects like an increased risk of severe magnesium deficiency (that can cause muscle cramps and heart arrhythmia), bone fractures and infection are listed in the fine print in the drug’s packaging, the group wants them mentioned more prominently in a black box warning.
Most importantly, they want the new warning to include the increased risk for rebound acid reflux — a savage flare-up of acid reflux symptoms after the medication is discontinued that encourages patients to become dependent on the drug for relief. This side effect is currently not included on the drug’s packaging.
Most worrisome is that otherwise healthy people can develop more serious acid reflux from taking PPIs for common indigestion and heartburn, thanks to this rebound effect, a 2009 study found.
In addition to the black box warning, the group wants drug labels to list that PPIs may reduce the effectiveness of some heart drugs, as well as interfere with the effectiveness of some chemotherapy drugs.
“It’s absolutely true that too many people are on these medications,” Dr. Jacqueline Wolf, a gastroenterologist at Harvard Medical School told ABC News. “I think physicians need to be aware of the medications’ risk and get patients to try lifestyle changes and antacids first. I absolutely agree we need to taper off these drugs.”
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