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April 30, 2014

Public Citizen Sues FDA for Failing to Take Action on Petition Concerning Dangerous Proton Pump Inhibitors

Agency Has Failed to Respond to 2011 Petition Calling for Strong Warnings on Stomach Acid Drugs

WASHINGTON, D.C. -- Public Citizen sued the U.S. Food and Drug Administration (FDA) today for failing to respond to the organization’s petition requesting black box warnings on common but dangerous anti-stomach acid medications, known as proton pump inhibitors (PPIs). Although more than two and a half years have passed since Public Citizen filed its petition, the FDA has neither granted nor denied it, and has not required adequate warnings on the drugs.

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 the United States, with 131 million prescriptions dispensed in 2013. An estimated 1 of every 20 people in the developed world is taking the medications, which include Nexium, Nexium 24HR, Dexilant, Prilosec, Prilosec OTC, Zegerid, Zegerid OTC, Prevacid, Prevacid 24-Hr, Protonix, Aciphex, Vimovo and numerous generic counterparts, most prominently omeprazole and pantoprazole.

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 FDA hasn’t properly warned consumers,” said Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group. “The agency has had more than two and a half years to respond to our petition. Meanwhile millions of people are taking these drugs without adequate warnings. The urgency of our petition is that only with these additional, serious warnings, will unnecessary PPI use decrease rather than continually increase.”

Public Citizen’s petition asked the FDA to: 1) add “black box” warnings for four serious adverse events and additional safety information to all PPI product labeling; 2) require sufficiently informative patient Medication Guides for all prescription PPIs; and 3) request that sponsors of all prescription PPI medications send a “Dear Doctor” letter to physicians and other providers that includes the black box warnings and other labeling changes described in the petition.

Public Citizen filed today’s lawsuit in the U.S. District Court for the District of Columbia. Public Citizen seeks: 1) a declaration that the FDA has acted unlawfully by withholding action on the petition; and 2) an order requiring the FDA to act within 30 days.

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