By THOMAS H. MAUGH II
Los Angeles Times
Older people who take heartburn drugs such as Nexium, Prilosec, Prevacid and Protonix for long periods have a significantly increased risk of hip fractures, possibly because the drugs block calcium absorption, Pennsylvania researchers reported Wednesday.
The drugs, which block production of acid in the stomach, are among the most widely used in the United States with combined annual sales of more than $10 billion.
"The perception is that the drugs are completely safe, and doctors dispense them without thinking too much about the risks and the benefits," said Dr. Yu-Xiao Yang of the University of Pennsylvania School of Medicine, who led the study published in the Journal of the American Medical Association.
Now, he said, physicians should be aware of the potential risk, prescribe the lowest possible dose and use the drug only on patients who really need it.
Men using heartburn drugs ran twice risk of women, study says
An estimated 300,000 Americans older than 65 sustain hip fractures each year, according to the National Institutes of Health, and recovery is difficult. About 20 percent die of complications and another 20 percent are consigned permanently to nursing homes.
The findings are interesting, said Dr. Alan Buchman of Northwestern University, but the results do not prove that the drugs caused the increased risk.
"Maybe they have some other problem that increases the risk for fractures," he said.
Even if the drugs are at fault, the solution may be simply to consume more calcium, either in the form of dairy products or as supplements, said Buchman, who was not involved in the study. "The average North American doesn't get enough calcium anyway," he said.
Drug manufacturers noted that the products have been used for more than 10 years and have been through many clinical trials without evidence of risk.
Amy Allen, a spokeswoman for TAP Pharmaceuticals Inc. of Lake Forest, Ill., which manufactures Prevacid, said the company has an extensive post-marketing surveillance system and "has not identified a safety signal for bone fractures related to Prevacid."
Heartburn typically occurs when acid from the stomach bubbles up into the esophagus, a condition called acid reflux. It is very painful and can cause ulcers on the lining of the esophagus. Some researchers believe it also can lead to cancer.
Yang and his colleagues used a large British database to identify 13,566 hip fracture patients over age 50 and a matched group of 135,386 healthy people.
They found that one year of using the drugs increased risk of hip fractures by 44 percent. Long-term users who received high doses of the drugs had as much as 2.6 times the normal risk.
Men using the drugs had about twice the risk of hip fractures as did women, perhaps because the women were more likely to be consuming calcium supplements as post-menopausal therapy.
Patients taking a different class of acid inhibitors that includes Tagamet, Zantac, Pepcid and Axid had a 21 percent increased risk of fractures after one year.
The results are similar to those obtained in a smaller Danish study reported this year, Yang said.
Yang, who has received funding from several manufacturers, pointed out that adequate levels of acid are required in the duodenum to dissolve calcium salts so they can be absorbed by the body. Studies in animals have suggested that the acid blockers can interfere with this process, producing a calcium deficiency that, in turn, leads to a thinning of bones.
What's needed now, Buchman said, is a study that looks directly at bone-mineral density to determine whether it decreases in patients receiving the drugs.
The study was funded by the National Institutes of Health and the American Gastroenterological Association/GlaxoSmithKline Institute for Digestive Health.
Heartburn typically occurs when acid from the stomach bubbles up into the esophagus, a condition called acid reflux. It is very painful and can cause ulcers on the lining of the esophagus. Some researchers believe it also can lead to cancer.
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