Long term use of proton pump inhibitor class of drugs may increase the risk of bone fractures of the hip, wrist, and spine.
The U.S. Food and Drug Administration (FDA) on 25-may-2010 issued a drug safety communication for use of drug of class known as proton pump inhibitors US FDA says they are revising labelling requirements which will include safety information for a class of drugs known as proton pump inhibitors on prescription and over the counter (OTC) drugs.
Proton pump inhibitors drugs reduces the acid in the stomach. They are used to treat conditions such as gastroesophageal reflux disease (GERD), ulcers in stomach and small intestine, and inflammation of the esophagus,and are used in the treatment of frequent heartburns.
The U.S. Food and Drug Administration (FDA) said in their news release , that the new safety information issued is based on reviews of several epidemiological and clinical studies where it is found that in case of prolonged treatment with proton pump inhibitors there is an increased risk of fractures in bones of wrist, spine and hip.
In some studies it is reported that patients at greatest risk for these fractures were received high doses of proton pump inhibitors or proton pump inhibitor drugs were used by them for one year or more than one year , there is a complete data available on FDA’S website in news release .These studies mostly evaluated peoples in the age group of 50 years or older where the increased risk of fracture in bones primarily was observed in this age group.
The “Drug Facts” label on the OTC proton pump inhibitors is also being revised to include the information about this risk.
The use proton pump inhibitors should be taken in to consideration of the current findings while treating the patients as well as while using proton pump inhibitors one should consider the benefits against the potential risks while deciding the treatment with proton pump inhibitors and its duration .
Proton pump inhibitors inhibit gastric acid secretion through irreversibly blocking of the enzyme system hydrogen/potassium adenosine triphosphatase ,the H+,K+ ATPase, or, gastric proton pump of the gastric parietal cell. Since this step is the last stage in gastric acid secretion, which is secrets H+ ions into the gastric lumen.
Example of drugs are as follows.
Proton pump inhibitors drugs are used in the treatment following conditions :
Peptic ulcer disease (PUD)
Gastroesophageal reflux disease (GORD/GERD)
prevention of stress gastritis
Gastrinomas and other conditions that cause hypersecretion of acid
Why there is increase in risk of bone fracture in prolonged use of Proton pump inhibitors drugs
Acidic environment is essential for the digestion of proteins and for the absorption of nutrients, predominantly of vitamin B12 and of calcium. In case of long term use of Proton pump inhibitors decreased vitamin B12 absorption may occur .
Main cause of the increased risk of bone fracture is the reduction in gastric acid which reduces the amount of calcium dissolved in the stomach , Proton pump inhibitors may also interfere with the breakdown and rebuilding of bone by interfering with the acid production of osteoclasts , and the reduction of vitamin B12 ,due to raising homocysteine, are the theories which may explain the possibilities of increases risk of bone fragility.
Other adverse effects
Proton pump inhibitors, is may increase the risk of community-acquired pneumonia , due to insufficient elimination of pathogenic microorganisms as a effect of decreased gastric acid environment .
Proton pump inhibitors may develop dependency in patients by means of increasing gastric symptoms if proton pump inhibitors are discontinued.
Proton pump inhibitors treatment should used in antiplatelet dual therapy .
Advice to patients and doctors
Patients should not stop taking drug proton pump inhibitor unless it is asked by their doctor ,in case if benefits over weighs the risk , the increased risk of fractures in bones of the hip, wrist, and spine.
Read and follow the directions on the OTC Drug Facts label, when considering use of OTC proton pump inhibitors.
Be aware that the OTC proton pump inhibitors should only be used as directed for 14 days for the treatment of frequent heartburn. If your heartburn continues, talk to your healthcare professional. No more than three 14-day treatment courses should be used in one year.
Talk to your healthcare professional about any concerns you may have about using proton pump inhibitors.
When prescribing proton pump inhibitors, consider whether a lower dose or shorter duration of therapy would adequately treat the patients condition.
Follow the recommendations in the product labeling when prescribing proton pump inhibitors.
Individuals at risk for osteoporosis should have their bone status managed according to current clinical practice, and should take adequate vitamin D and calcium supplementation.
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