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FDA Says Heartburn Drugs Linked To C. Diff | cialis online

FDA Says Heartburn Drugs Linked To C. Diff

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The U.S. Food and Drug Administration (FDA) has announced that certain heartburn drugs, known as PPIs, are linked to Clostridium difficile (C. diff).

Proton pump inhibitors (PPIs) are marketed under various brand and generic drug names as prescription and over-the-counter (OTC) products and work by reducing stomach acids. Prescription PPIs are meant to treat gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. OTC PPIs treat frequent heartburn. PPIs include AcipHex (rabeprazole sodium), Dexilant (dexlansoprazole), Nexium (esomeprazole magnesium), Omeprazole (omeprazole) OTC, Prevacid (lansoprazole) and OTC Prevacid 24hr, Prilosec (omeprazole) and Prilosec OTC, Protonix (pantoprazole sodium), Vimovo (esomeprazole magnesium and naproxen), and Zegerid (omeprazole and Sodium bicarbonate) and Zegerid OTC.

C. difficile is a bacterium that can cause diarrhea that does not improve. Symptoms include watery stool, abdominal pain, and fever. Patients may develop more serious intestinal conditions and C. diff can be spread in hospitals.

The FDA has notified the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be linked to an increased risk of C. diff–associated diarrhea (CDAD). A CDAD diagnosis should be considered for patients taking PPIs who develop diarrhea that does not improve.

The FDA said it is working with drug makers to include information on the drug labels about the increased risk of CDAD with use of PPIs. The agency said it is also reviewing CDAD risks in patients who use histamine H2 receptor blockers, prescribed for the treatment of GERD, stomach and small intestine ulcers, and heartburn.

The FDA is advising patients to immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve. Healthcare Professionals should consider a diagnosis of CDAD in for PPI users with diarrhea that does not improve. Also, said the agency, patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

PPIs are known to increase risks for a number of serious medical conditions such as fractures of the hip, spine and wrist; increased risks for serious infections—in addition to C. diff and diarrhea—such as pneumonia; and severe magnesium deficiency, which can lead to life-threatening cardiac arrhythmias. Last year, consumer watchdog, Public Citizen, petitioned the FDA to mandate drug makers list serious adverse reactions associated with PPIs in a prominent black box warning on their labels.

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