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Heartburn/GERD Health Center

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Acid Reflux Drugs May Up Fractures

Proton-pump inhibitors -- the popular drugs that fight stomach acid -- increase the risk of hip fractures, a U.S. study shows.

Proton Pump Inhibitors and Calcium continued...

The researchers suggest that proton-pump inhibitors may have "an exaggerated effect" among people already at risk of osteoporosis. They urge doctors to prescribe the drugs at the lowest effective dose.

They also urge elderly patients who need high-dose, long-term treatment with proton-pump inhibitors to get more calcium. This calcium, Yang and colleagues suggest, should be consumed in the form of dairy foods. If patients take calcium supplements, they should remember to take them with a meal.

Manufacturers Respond

WebMD asked the drug companies that make proton-pump inhibitors to comment on the study.

Wyeth Pharmaceuticals makes Protonix. Wyeth notes that clinical trials of Protonix extended for up to 12 months. In that period, fewer than 1% of patients suffered bone disorders.

"Wyeth is aware of the study on PPIs and risk of hip fracture," the company tells WebMD. "As always, we are continuing to monitor our safety database. Wyeth places patient safety at the center of our activities worldwide."

The recommended adult daily dose of Protonix is one 40 milligram delayed-release tablet.

AstraZeneca makes Nexium and Prilosec. Doug Levine, MD, clinical development leader for AstraZeneca, tells WebMD in a written statement that the Yang study provides important information that must be interpreted in the context of other data.

"This study does not establish a direct causal relationship between hip fractures, which were assumed to be secondary to osteoporosis, and either proton-pump inhibitors or other acid suppressive medications," Levine writes. "This study does suggest a 'potential association,' as characterized by the authors of the study."

Levine notes that "hip fractures and osteoporosis are attributable to many other well-established medical and circumstantial risk factors" other than proton-pump inhibitors. He stresses that "oversight of at-risk patients by physicians and other health care professionals is very important to help define and employ interventional clinical management strategies that may help prevent hip fractures and treat or prevent osteoporosis."

TAP Pharmaceutical Products Inc. makes Prevacid. Amy Allen, TAP's associate director for public affairs, provided a written statement to WebMD.

"For more than 10 years, proton pump inhibitors (PPIs) have been used to treat millions of patients suffering from acid-related disorders, and the safety and efficacy of PPIs have been well established through many randomized, controlled clinical trials, which are considered to be the gold standard for evaluating the risks and benefits of medicines," Allen writes. "The study discussed in this article is a retrospective analysis which is usually not sufficient to prove or disprove potential hypotheses."

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