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Health News From MedPage Today
FDA Issues Warning on Acid Reflux Drugs
Proton pump inhibitors may increase the risk of severe diarrhea.
By Todd Neale, Senior Staff Writer, MedPage Today

WEDNESDAY, Feb. 8, 2012 (MedPage Today) — The FDA warned today that use of proton pump inhibitors (PPIs) to treat gastroesophageal reflux disease (GERD) — including popular brands such as Nexium, Prilosec, and Prevacid — may increase the risk of Clostridium difficile-associated diarrhea, which is serious and may contain blood or pus.

The warning comes after a review of data from the agency's Adverse Event Reporting System and the medical literature suggested such a link, and an analysis reported at the 2010 meeting of the American College of Gastroenterology yielded the same finding.

Many of the adverse cases involved patients who were elderly, had underlying medical conditions, or were taking broad spectrum antibiotics. All of those factors could have contributed to the greater risk of C. difficile-associated diarrhea, but the use of PPIs could not be excluded.

The FDA advised healthcare providers to consider a diagnosis of C. difficile-associated diarrhea if patients taking PPIs present with diarrhea that is not improving and said patients should take the lowest dose of PPI for the shortest time possible to improve the condition being treated.

The agency is working with the drug makers to modify the labels to include the possible risk of C. difficile-associated diarrhea.

The warning applies to the following PPIs, both prescription and over-the-counter:

rabeprazole sodium (AcipHex)
dexlansoprazole (Dexilant)
esomeprazole magnesium (Nexium)
omeprazole OTC
lansoprazole (Prevacid) and Prevacid 24hr OTC
omeprazole (Prilosec) and Prilosec OTC
pantoprazole sodium (Protonix)
esomeprazole magnesium and naproxen (Vimovo)
omeprazole and sodium bicarbonate (Zegerid) and Zegerid OTC

PPIs have been associated with other adverse events in the past, including resistance to clopidogrel (Plavix), low magnesium levels resulting in a greater risk of leg spasms, arrhythmias, and seizures, greater risk of osteoporotic fractures from chronic use, and cardiac birth defects when used during pregnancy.

The FDA is also reviewing the possible risk of in C. difficile-associated diarrhea in users of another class of acid suppressing medications, the histamine H2 receptor blockers.

Thanks Kelly Jo. Thanks N2 for posting.

Thanks, Kelly Jo! Saw this on twitter and had to share.

Thanks for the post. I have printed it for my surgeon. He probably already knows about it, but I sure couldn't resist walking in with this, in hand. I had 3 bouts with C-Dif, the 3rd. put me in the hospital for 5 days. Besides the diarrhea, my potasium and magnesium levels nearly bottomed out & I was in kidney failure. I got my choice of the nastiest tasting liquid potasium or to put it in my IV, which burned for the next 2 hours, followed by a bag of magnesium. I went from great to bottoming out. Finally, when I had 2 good days, they sent me home with more C-Dif killers. (on top of it all, I was in isolation). I consumed, 4 times a day, a probiotic. Doctor told me that was the only sure way to kill off the spors that live in my colon. I wonder if I'll ever get completely rid of it. My family doctor told me that once a person gets it, there is a greater chance to get it again. Lovely, huh?