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Nov. 3, 2014

FDA’s Partial Approval of Public Citizen’s Petition for Stronger Warnings on Certain Proton Pump Inhibitor Products Comes Too Late

Statement by Sidney M. Wolfe, MD, Founder and Senior Adviser, Public Citizen’s Health Research Group

Note: On Friday, Oct. 31, the U.S. Food and Drug Administration both accepted and rejected portions of Public Citizen’s 2011 petition for stronger warnings on certain common antacid medications. It acted in response to a lawsuit filed by Public Citizen against the agency for unreasonably delaying action on the petition.

It now has been more than three years since the U.S. Food and Drug Administration (FDA) received our urgent 2011 petition for stronger warnings and patient medication guides on all proton pump inhibitor (PPI) products (such as Nexium, Prevacid, Prilosec, Protonix and several over-the-counter versions). It also has been six months since we sued the agency in federal District Court for unreasonable delay in responding to our petition. The FDA finally responded to our petition last Friday.

In its response (PDF), the FDA agreed with and granted the following requests:

  • “In the labeling of all PPI products, addition of information regarding the risk of Clostridium difficile-associated diarrhea and the risk of drug-drug interactions between PPIs and mycophenolate mofetil [anti-transplant rejection drug] and methotrexate [for rheumatoid arthritis and other conditions];
  • In the labeling of certain PPI products (omeprazole [Prilosec] and esomeprazole [Nexium]), addition of information regarding the risk of drug-drug interactions with clopidogrel [Plavix];
  • In the labeling of certain prescription PPI products, addition of information regarding the risks of vitamin B 12 deficiency and acute interstitial nephritis and certain information regarding treatment length for gastroesophageal reflux disease (GERD); and
  • Issuance of Medication Guides for certain prescription PPI products regarding certain safety risks.”

The approved uses for prescription PPIs include treatment of gastroesophageal reflux disease (GERD), erosive and ulcerative esophagitis, peptic ulcer and H. pylori eradication, pathological hypersecretory conditions, and upper-gastrointestinal bleeding prophylaxis in critically ill patients and those taking nonsteroidal, anti-inflammatory medications. However, PPIs are often prescribed for conditions they aren’t approved to treat. Many studies have found that the majority of people on PPIs were not prescribed them for an approved use.

The FDA’s rejection of our request for black box warnings on all these medications was misguided. The agency stated that three very serious conditions – C. difficile diarrhea, osteoporotic fractures and hypomagnesemia (low magnesium in the blood) – were not serious enough or occurred too infrequently to warrant such warnings. The agency also denied our request that several other warnings be added.

Although we are disappointed in the rejection of certain requests, the portions of the petition granted by the agency are important and will make the products safer. At the same time, it is unconscionable that the agency took more than three years to respond. The evidence for all of the warnings now granted was available more than three years ago, but the agency unreasonably delayed, endangering millions of patients.

In 2013, 130 million prescriptions were filled in the U.S. for these grossly overused products, which have evidence of serious adverse reactions, as we documented in our petition (PDF). The FDA delay, in addition to being unreasonable by the standards of the Administrative Procedures Act governing petitions to the government, has posed needless, avoidable, serious dangers to millions of patients in this country.


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