Public Citizen Pushes FDA for Stronger Warnings on Proton Pump Inhibitors

A consumer watchdog wants to make sure users of <"">proton pump inhibitors are aware of their serious side effects, including long-term dependency issues, fractures and magnesium deficiency. This week, Public Citizen petitioned the U.S. Food & Drug Administration (FDA) to require that manufacturers list these and other serious adverse reactions associated with the popular heartburn drugs in a prominent black box warning on their labels.

Proton pump inhibitors include Nexium, Dexilant, Prilosec, Prilosec OTC, Zegerid, Zegerid OTC, Prevacid, Prevacid 24-Hr, Protonix, Aciphex, and Vimovo. They 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. According to a statement from Public Citizen, these drugs are taken by one in 20 people in the developed world.

According to the group, evidence shows that after using proton pump inhibitors for a month or more, patients who stop taking the drug make even more stomach acid than before they started, a phenomenon known as rebound acid hypersecretion. This causes acid reflux symptoms to return even worse than before therapy, and patients begin taking the drugs again, leading to long term dependency.

Proton pump inhibitors also 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. While these and other serious side effects are listed in the fine print of the drugs’ labels, none are given prominence via a black box warning, Public Citizen said. As a result, many physicians may not be aware of the serious risks associated with PPI therapy,

Public Citizen also pointed to studies showing that two-thirds of all people taking proton pump inhibitors 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, acid reflux and other conditions can be treated with safer alternatives that are often just as effective, Public citizen said.

“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 (proton pump inhibitors) 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.”

In addition to petitioning the FDA to require a more prominent black box warning for the product labels of all proton pump inhibitors on the market, Public Citizen is also calling for patient medication guides to be distributed with the drugs. Finally, the group wants the makers of proton pump inhibitors to send a letter to doctors alerting them to all of their side effects and of the need to try safer alternatives first.

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