Public Citizen Sues FDA for Failing to Take Action on Petition Concerning Dangerous Proton Pump Inhibitors
Targeted News Service
Public Citizen sued (http://www.citizen.org/documents/2196a.pdf) the
PPIs are approved to treat gastroesophageal reflux disease (GERD) - sometimes referred to as acid reflux - as well as peptic ulcers, erosive esophagitis and stomach bleeding in critically ill patients and those using non-steroidal anti-inflammatory treatments (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 medication, 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 PPIs again, creating a long-term dependence on these medications, particularly worrisome for the large number of patients who did not even need the drugs in the first place.
PPIs are one of the most widely used classes of drugs in
In addition to creating dependence, PPIs increase the risk for several serious conditions, including fractures of the hip, spine and wrist; serious infections such as pneumonia and C. difficile diarrhea; and severe magnesium deficiency, which can cause life-threatening cardiac arrhythmias. Although some of these side effects already are mentioned somewhere in the labels (not the case for dependence), none of these four risks - including those that are life-threatening - are displayed prominently as black box warnings, the strongest possible warning, as requested in Public Citizen's 2011 petition.
"These drugs are habit-forming, dangerous and overprescribed, but the
Public Citizen's petition (http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3403) asked the
Public Citizen filed today's lawsuit (http://www.citizen.org/documents/2196a.pdf) in the
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