A recently-published study has confirmed that patients who use Nexium and other proton pump inhibitors may be more likely to develop osteoporosis. This disorder, which results in weak, brittle bones, greatly increases the likelihood of fractures.
The study, which appeared in the May issue of the International Journal of Rheumatic Diseases, involved data from 80 patients (31 male and 49 female) aged 20-45 year. None had a history of hip fractures, AND half were using proton pump inhibitors. All were followed for two years. X-rays were evaluated to assess bone mineral density in the femur (T-scores) and spine (Z-scores) in all 80 subjects.
While the study authors did not find a significant difference in Z-scores between proton pump inhibitor users and non-users, there were differences in T-scores between the two groups.
“Our study demonstrated that mean femoral T-scores were significant between PPI and non-user groups (−0.44 ± 1.11 vs. +0.19 ± 0.95, P = 0.007). In addition, the frequency of femoral osteoporosis and osteopenia in the exposed group was significantly more in the control group (P = 0.04),” they wrote.
“Overall, the results of this study showed that PPI use in subjects without risk factors of osteoporosis determined by the femoral T-score compared with the control group was associated with increased risk of developing osteoporosis and osteopenia in the femur bones,” the report concluded.
In 2010, the U.S. Food & Drug Administration (FDA) announced it was requiring new warnings regarding hip, spine and wrist fractures for the labels of all prescription and over-the-counter (OTC) proton pump inhibitors. The agency acted after a number of studies suggested that the drugs – especially when used for extended periods of time and at the highest dosage – could increase the risk for these types of fractures.
A year later, however, the FDA rescinded its fracture warning for OTC proton pump inhibitors, after concluding that the risk with short-term, low dose use was unlikely.
“In contrast to prescription PPIs, OTC PPIs are marketed at low doses and are only intended for a 14 day course of treatment up to 3 times per year,” the agency stated. “FDA acknowledges that consumers, either on their own, or based on a healthcare professional’s recommendation, may take these products for periods of time that exceed the directions on the OTC label. Healthcare professionals should be aware of the risk for fracture if they are recommending use of OTC PPIs at higher doses or for longer periods of time than in the OTC PPI label.”
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