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Some Doctors Decrease Use of Heart Burn Drugs Following FDA Fracture Warning

Sep 15, 2010 | Parker Waichman LLP

A new study has found that many doctors plan to reduce their prescribing of heart burn drugs known as proton pump inhibitors. The trend was inspired by the US Food & Drug Administration’s (FDA) May announcement that it was changing safety labels on proton pump inhibitors to reflect a possible increased risk for fractures.

Proton pump inhibitors, available by prescription and over-the-counter (OTC), work by reducing the amount of acid in the stomach, and are approved to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Prescription versions of the drugs include Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, and Aciphex. OTC brands include Prilosec OTC, Zegerid OTC and Prevacid 24HR.

It’s thought that when proton pump inhibitors reduce acid secretion by the stomach, it results in decreased calcium absorption. Calcium malabsorption is now being recognized as a significant side effect in patients who have taken these drugs for an extended period of time.

The FDA announced the label change after a review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist, and spine with proton pump inhibitor use. Some studies found that those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group, the agency said.

Now, a study conducted by dtw Marketing Research Group, Inc. found that 22 percent of physicians expect to decrease their usage of prescription proton pump inhibitors because of the FDA safety review. Sixty-one percent said the FDA’s action would change how they advise patients.

The study tracked primary care physicians and gastroenterologists between June 23rd and June 25th, 2010. The potential respondents were asked to complete a survey if they had written at least 25 prescriptions for proton pump inhibitors in the past 30 days. Fifty-two primary care physicians and 51 gastroenterologists responded to the survey.


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