Thirteen individual have sued the makers of Nexium and Prevacid in California state court alleging the drug maker failed to adequately warn doctors and consumers that the acid reflux drugs cause bone loss and osteoporosis.
Nexium, manufactured by AstraZeneca, and Prevacid, made by Takeda, are associated with a significantly increased risk of hip, wrist and vertebral spine fractures and cause bones to deteriorate and break.
This first lawsuit was filed in the San Francisco County Superior Court asserting that AstraZeneca Pharmaceuticals, Inc. and Takeda Pharmaceuticals USA, Inc. failed to conduct adequate and sufficient post-marketing surveillance of adverse events caused by ingestion of Nexium and Prevacid after they began marketing the drug.
Plaintiffs claim the drug makers engaged in aggressive over-promotion and overstated the risk/benefit profile for the drugs, despite knowing the long-term use of the drugs can cause bone loss. Early studies of proton pump inhibitors (“PPI”) such as Nexium and Prevacid showed that the drugs interfere with the body’s ability to absorb calcium, thereby speeding up bone loss and leading to an increased number of fractures.
Plaintiffs in this first lawsuit assert that in total, six studies have found the risk of fracture significantly increased for those patients over 50 years of age who took a prescription- strength PPI, like Nexium and Prevacid, or who took a PPI regularly for more than one year.
In March 2011, the Food and Drug Administration (“FDA”) issued a safety alert stating that use of prescription PPIs results in an increased risk of fractures. The FDA required PPI manufacturer to include safety information and warnings about the increased risk of osteoporosis and fractures associated with PPIs in the warning labels for the acid reflux medications.
The lawsuit states that the makers of Nexium and Prevacid knew or should have known about the correlation between the use of the drug and fractures, yet touted them as safe and effective to consumers, prescribing physicians and the public in general. In addition, Defendants also fraudulently concealed the fact that the drugs put users at risk of suffering serious and dangerous side effects, including fractures to the hips, wrist and spine, as well as other severe and personal injuries.
This lawsuit also alleges that Defendants had a post-sale duty to warn the medical, pharmaceutical and scientific communities, and users and consumers of the drugs, including plaintiffs, about the potential risks and serious side effects associated with the use of the products in a timely manner. They failed to provide such warning.
According to the complaint, hundreds of reports of injury and death have been submitted to the FDA in association with Nexium and Prevacid during the time they were sold in the United States.