Philadelphia, PATwo recent studies have shown a link between osteoporosis proton pump inhibitors (PPIa), used for the treatment of heartburn. The US Food and Drug Administration has ordered the makers of the drugs to include a warning about PPI side effects, including over-the-counter PPIs.
A 2008 study conducted by the University of Manitoba, in Canada, analyzed patients who took proton pump inhibitors over a period of five to seven years and found that such patients had five times the risk of a hip fracture.
An older study, conducted by the University of Pennsylvania in 2006, found that patients who took heartburn medications continuously for more than a year had a 44 percent increased risk of experiencing a hip fracture.
Proton pump inhibitors help relieve heartburn by reducing the production of gastric acid (stomach acid) in the body. The problem reportedly occurs when patients use the medications at a high dose or long-term, for more than a year. People aged 50 or older are at the highest risk of fracture.
On May 25, 2010, the US Food and Drug Administration (FDA) issued a warning about the link between proton pump inhibitors and an increased risk of hip, spine and wrist fractures. Medications in the proton pump inhibitor class are now required to carry a warning on the label, alerting patients to the increased risk of fracture.
As a precaution, the FDA requires that over-the-counter proton pump inhibitors (approved for 14 days of continuous use) also carry the warning label. According to the FDA safety alert, patients should use no more than three 14-day proton pump inhibitor courses in one year.
In making its announcement, FDA reviewed data from seven published epidemiological studies. Of those studies, six found an increased risk of fractures when patients used proton pump inhibitors. Two studies found an increased risk of fractures with higher doses of proton pump inhibitors, while two found an increase in fractures with longer duration of use. One study found an increase in fractures after five to seven years of use of the medications.
One study did not find a relationship between the use of proton pump inhibitors and the risk of fractures. That study was limited to a population that did not have major risk factors for fracture.
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