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Osteoporosis-related wrist fractures are one of the possible side effects of using Nexium®, especially when this heartburn medication is used for a year or longer or in high prescription doses (defined as more than one prescription dose a day).

Nexium® Wrist Fracture

The drug label's warning section says that because of an increased risk of wrist fractures, as well as fractures of the hip and spine, patients should use the "lowest dose" and "shortest duration of PPI (proton pump inhibitor) therapy appropriate to the condition being treated." Nexium® is a heartburn medication and is in a class of drugs called proton pump inhibitors, which reduce the amount of acid the stomach produces.

FDA Warning and Nexium Wrist Fractures®

The FDA reviewed information from seven published epidemiological studies about a connection between taking Nexium® and fractures of the spine, hip and wrist. When taken together and analyzed, the information suggested a relationship between duration and amount of dose and the development of fractures.

In six of the seven studies, fractures appeared related to:

• Taking PPIs for a year or longer (found in two studies)
• Taking a high dose (multiple times daily) of the prescription drug (found in two studies)
• The age of the patient, with fractures being more common in older patients

The FDA said because it did not have access to the data or protocols for the studies, its ability to verify that they were conducted as described was limited. But, based on its review of the published articles, the agency said the studies seemed to be:

• Well designed
• Considered both duration and amount of dosage in arriving at its conclusions of risk of fracture
• Used proper statistical methods to reduce bias by taking into account the patients’ age, gender, and presence of other conditions or medicines

To gather more information, the FDA said it intends to look into the issue further. The agency plans to analyze data from several large, long-term, placebo-controlled clinical trials as well as work with the manufacturers of PPIs to do additional studies of the risk of wrist fractures.

Contact a Nexium® Lawyer

If you have taken Nexium® and suffered a fracture of your wrist, hip or spine, you may be eligible to file a legal claim. Our Nexium® lawyers are available to help injured patients across the country. Contact us today for more information.