FDA: Antacids Raise Bone Fracture Risk
Written By: FDA
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Published - May 26, 2010
The Food and Drug Administration (FDA) warned on Tuesday (May 26,2010) that a class of drugs called proton pump inhibitors or PPIs or commonly called antacids when used for a long term or at high doses increase risk of fractures of the hip, wrist, and spine.
Proton pump inhibitors including Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, and Vimovo available by prescription are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus by reducing the amount of acid in the stomach, according to the FDA.
OTC antacids including Prilosec OTC, Zegerid OTC, and Prevacid 24HR are sold over the counter for the treatment of frequent heart burn.
The warning came after the FDA reviewed several epidemiological studies and found an increased risk of fractures of the hip, wrist and spine in patients who had been using PPIs.
The fracture risk was elevated in patients who used the drugs for a year or longer or at high doses. The studied patients were mostly at the age of 50 or older.
“Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump inhibitors for one year or longer, or at high doses,” said Joyce Korvick, M.D., deputy director for safety in FDA’s Division of Gastroenterology Products.
“Because these products are used by a great number of people, it’s important for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition.”
The FDA gives consumers the following advice as to how to use PPIs:
Don’t stop taking your drugs unless your healthcare professional tell you to do so;
Be aware of the increased risk of fractures of the hip, wrist and spine reported in studies of patients using antacids. High risk was found in those who take high doses of the drugs longer than 1 year or longer.
Read and follow the directions on the OCT Drug Facts label when considering to use antacids;
OTC PPIs should only be used as directed for 14 days to treat frequent heartburn. If heartburn continues, talk to your doctors;
Talk to your physicians if you have any questions;
Report any side effects with proton pump inhibitors.