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Osteoporosis, GERD and Proton Pump Inhibitor's

Posted Mar 31 2012 2:25pm
(bold print from the FDA web site)
Proton Pump Inhibitors (PPI): Class Labeling Change
including Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, Vimovo, Prilosec OTC, Zegerid OTC, and Prevacid 24HR
[UPDATED 3/22/2011] FDA has determined an osteoporosis and fracture warning on the over-the-counter (OTC) proton pump inhibitor (PPI) medication “Drug Facts” label is not indicated at this time. Following a thorough review of available safety data, FDA has concluded that fracture risk with short-term, low dose PPI use is unlikely.

The National Institute of Health (NIH) argues gastroesophageal reflux disease (GERD) is the most common reason for doctor visits. Besides heartburn and indigestion, many unknowingly suffer from atypical GERD masquerading as mucus problems, loss of dental enamel, headache, stiff neck, insomnia, cough, asthma, etc. Relief is generally from commonly used stomach acid reducers, the proton pump inhibitors (PPI’s): Prilosec*, Zegerid*, Prevacid*, AcipHex, Protonix, Nexium and Dexilant (*available over-the-counter [OTC]). The Food and Drug Administration (FDA) allows medicines OTC only after addressing safety concerns. When PPI’s became available (1980’s), time limits (long since rescinded) were placed on continuous patient use while concerns with pneumonia, impaired protein, iron or B12 absorption, interference with Plavix, and other affects have also been alleviated. Relationships with infectious diarrhea and low magnesium levels remain unconfirmed. About 3% of patients can experience headache, upset stomach or diarrhea. See tbe bold print above revealing short term PPI use has very recently been "cleared", so currently (FDA) has an alert concerning osteoporosis with long term PPI use. However the American Journal of Gastroenterology recently reported analysis of 1,600 studies and found no significant bone risk identified with ongoing PPI use. Medication benefits need to exceed (or “match”) the risk. Extensively studied, PPI’s have exceeded safety expectations. The goal of therapy is to control symptoms, prevent serious complications of GERD (like bleeding, ulceration, scar tissue, Barrett’s esophagus, cancer of the esophagus) and improve quality-of-life. PPI’s are available for long term use when significant benefits exceed potential risks. Other medications and surgical procedures could be options.
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