Safety Alerts & Recalls

What does this mean?

PPIs and H2 receptor blockers are effective in controlling stomach acid production and the benefits of these medicines will continue to outweigh the risks for most patients. However, this safety alert is a good reminder of the importance of regularly discussing with your doctor the risks and benefits of your PPI or H2 receptor blocker, especially if you have been taking it for a long period of time. Please do not stop taking your medication without first speaking with your doctor or other healthcare professional.

If you use PPIs and develop diarrhea that does not improve, seek medical care as soon as possible. This may be a sign of Clostridium difficile–associated diarrhea (CDAD). The most common symptoms of a C. difficile infection include watery diarrhea, fever, loss of appetite, nausea, and belly pain and tenderness. If you have a history of C. difficile infections, make sure you review this safety alert with your doctor or other healthcare professional.

If you are taking over-the-counter medicines like lansoprazole (Prevacid 24HR), omeprazole (Prilosec OTC), omeprazole and sodium bicarbonate (Zegerid OTC), cimetidine (Tagamet HB), famotidine (Pepcid Complete, Pepcid AC), nizatidine (Axid AR), or ranitidine (Zantac), follow the directions on the package carefully. If you have not talked to your doctor about your heartburn, indigestion, or acid reflux, it is a good idea to make an appointment with your doctor to discuss your symptoms and the use of these over-the-counter medications.

If you have any questions about your PPI or H2 receptor blocker, please follow up with your doctor or other healthcare professional.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Issues Safety Announcement: Proton Pump Inhibitors (PPIs) Possibly Associated with Clostridium Difficile-Associated Diarrhea (CDAD)

The Food and Drug Administration (FDA) has notified the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea that does not improve. Symptoms include watery stool, abdominal pain, and fever, which could progress to more serious intestinal conditions in some cases.

Proton pump inhibitors (PPIs) are marketed under various brand and generic drug names as prescription and over-the-counter (OTC) products. They work by reducing the amount of acid in the stomach. Prescription PPIs are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Over-the-counter PPIs are used to treat frequent heartburn.

Prescription proton pump inhibitor (PPI) drugs include dexlansoprazole (Dexilant), esomeprazole (Nexium), esomeprazole and naproxen (Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec), omeprazole and sodium bicarbonate (Zegerid), pantoprazole (Protonix), and rabeprazole (AcipHex).

Over-the-counter (OTC) proton pump inhibitors include (PPI) lansoprazole (Prevacid 24HR), omeprazole (Prilosec OTC), and omeprazole and sodium bicarbonate (Zegerid OTC).

The FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers and will communicate any new information about this potential risk when it becomes available. H2 receptor blockers are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and heartburn. H2 receptor blockers are available as prescription and over-the-counter (OTC) products and include cimetidine (Tagament, Tagamet HB), famotidine (Pepcid, Duexis, Pepcid Complete, Pepcid AC), nizatidine (Axid, Axid AR), and ranitidine (Zantac, Tritec).

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Source: FDA
Publication Date: 2012-02-08
Last Updated: 2012-04-09
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