The issue for patients and lawyers is showing that the use of Nexium is what caused the bone fractures.
“People sometimes break their hips,” Stewart says. “We have to look at the medical records to see if we could link Nexium usage to the fracture. That includes looking at how long they were on Nexium and how high the dose was. We have to show that the fracture was probably caused by Nexium. We have to causally link the fracture to the drug.”
At issue is not whether or not Nexium is a bad drug but if patients had informed consent about taking the drug. This means showing that they were not given proper information about the risks associated with Nexium when they were prescribed it.
“Once a drug is approved by the FDA, it’s no longer a case of the drug being bad but about informed consent,” Stewart says. “The same is true of Nexium. Patients can still buy it and use it but before they didn’t have the option of knowing about the risk of bone degradation. But from the moment patients were put on notice about this possible side effect [via an updated FDA warning], if they continued to take the drug, they did so at their own risk.”
In May 2010, the US Food and Drug Administration (FDA) issued a warning that the risks associated with prescription-strength Nexium and other proton pump inhibitors included an increased risk of bone fractures. That risk increases with increased duration on the medication or higher doses. In 2011, the FDA warned that high doses of proton pump inhibitors - in both prescription and over-the-counter formulations - for a period of longer than a year are associated with an increased risk of osteoporosis, and hip, spine and wrist fractures. Patients who are concerned about the statute of limitations should know that the statute began running from that date.
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Meanwhile, a study published in the British Medical Journal (1/31/12) examined the association between the use of proton pump inhibitors and the risk of fracture. The study suggested that chronic use of the medications was associated with an increased risk of hip fractures, especially in women with a history of smoking.