Drugs
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Proton Pump Inhibitors Information
Proton pump inhibitors (PPIs) are used to treat certain gastrointestinal disorders and work by reducing the amount of acid in the stomach. They are available both as prescription and as over-the-counter (OTC) medications.
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Current Safety Information
- FDA Drug Safety Communication: Clostridum difficile - associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)
2/8/2012 FDA Drug Safety Podcast for Healthcare Professionals: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)
2/8/2012- Lansoprazole - Letter to Healthcare Professionals: Communication on lansoprazole delayed-release orally disintegrating tablets manufactured by Teva Pharmaceuticals
4/15/2011 FDA Drug Safety Communication: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs)
3/2/2011FDA Drug Safety Podcast: Risk of Low Magnesium Levels Associated with Long-Term Use of Proton Pump Inhibitors
3/11/2011- FDA Drug Safety Podcast for Healthcare Professionals: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs)
3/2/2011 FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors
5/25/2010; updated 3/23/2011FDA: Possible Fracture Risk with High Dose, Long-term Use of Proton Pump Inhibitors
FDA press release (5/25/2010)Proton Pump Inhibitors (PPI): Class Labeling Change
MedWatch information (5/25/2010)Possible Increased Risk of Bone Fractures With Certain Antacid Drugs
FDA consumer updatePodcast for Healthcare Professionals: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors
5/28/2010- FDA Drug Info Rounds: Proton Pump Inhibitors (PPIs)
Training video for practicing pharmacists (8/9/2010)
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Previous Communications
Update of Safety Review - Follow-up to the August 9, 2007, Communication about the Ongoing Safety Review of Omeprazole and Esomeprazole
12/10/2007FDA's Safety Reviews of Prilosec and Nexium Find No Evidence of Increased Rates of Cardiac Events
12/10/2007Early Communication About an Ongoing Safety Review of Omeprazole (Prilosec) and Esomeprazole (Nexium)
8/9/2007Prilosec OTC (omeprazole) Information
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