February 8, 2012 – The U.S. Food & Drug Administration (FDA) issued a warning today stating that the use of a popular class of heartburn drugs may increase the risk of Clostridium difficile-associated diarrhea. FDA’s warning came in response to a safety review from its Adverse Event Reporting System that suggested such a link. Proton pump inhibitor (PPI) drugs linked to Clostridium difficile-associated diarrhea include Nexium, Prilosec, Aciphex, Prevacid, Protonix, Vimovo, Zegerid, and Dexilant.
What’s the problem?
In response to the new information linking proton pump inhibitors to difficile-associated diarrhea, the FDA is advising healthcare providers to be aware of the association, and that patients should take the lowest dose of PPI for the shortest time possible to improve the condition being treated. The administration is requiring that pharmaceutical manufacturers update their drugs’ warning labels to reflect the risk of difficile-associated diarrhea.
Proton pump inhibitors are manufactured under a variety of brand names in both prescription and over-the-counter strengths. PPIs are designed to work by reducing the amount of acid in the stomach, and are used to treat conditions such as:
- gastroesophageal reflux disease (GERD)
- stomach ulcers
- small intestine ulcers
- inflammation of the esophagus
- frequent heartburn
Clostridium difficile (C. difficile) is a bacterium that, when ingested, has the potential to cause persistent diarrhea. C. difficile has been reported to spread easily in hospital settings. Symptoms may include:
- watery stools
- abdominal pain
- serious intestinal conditions
- cardiac birth defects in babies born to mothers who took PPIs during pregnancy