A new lawsuit has been filed against AstraZeneca alleging that the company failed to warn about the risk of kidney damage with Nexium, a medication used to treat heartburn and acid reflux. The plaintiff is a man from Illinois who says he started taking Nexium under the direction of his doctor. According to the lawsuit filed on his behalf, he developed chronic kidney disease while taking the so-called “purple pill”. He alleges that his gradual loss of kidney function stems from the use of Nexium, and alleges the drug maker failed to disclose this risk.
Nexium, Prevacid and Prilosec belong to a class of medications known as proton pump inhibitors (PPIs). These drugs work by lowering the amount of acid produced by the stomach. This year, two studies were published linking PPIs to an increased risk of kidney disease. These findings have fueled litigation over drugs such as Nexium.
The complaint states that the U.S. Food and Drug Administration (FDA) has received hundreds of adverse event reports regarding Nexium. AstraZeneca denies allegations over Nexium and kidney damage. The company has stated “AstraZeneca is confident in the safety and efficacy of Nexium and intends to vigorously defend this lawsuit.”
A study published in the journal JAMA Internal Medicine this January found that PPI use was associated with a 20 to 50 percent increased risk of chronic kidney disease compared with people who did not use PPIs. The risk increased with higher dosage. Participants taking a twice-daily dose had a 46 percent increased risk while those taking a once-daily dose had a 15 percent increased risk.
In April, another study was published in the American Society of Nephrology. Researchers studied the risk of kidney damage and PPIs by comparing two groups of participants: 170,000 new PPI users and 20,000 new H2 receptor blocker users. Overall, PPI use was linked to a 28 percent increased risk of chronic kidney disease. End-stage renal failure only occurred in a handful of PPI patients, but it was associated with a 96 percent increased risk. In both cases, the studies did not prove cause-and-effect. The findings only suggest an association.