The U.S. Food & Drug Administration (FDA) has finally given a go to Perrigo Company Plc., to market a store-brand equivalent of Nexium 24HR which is an OTC version of Nexium used to treat heartburns. Owing to the fact that Nexium is one of the largest selling prescription brands in the U.S., with sales crossing over $300 million in the last 12 months, Perrigo is expecting a good sales figure post the launch. However, the downside is that long-term use of Proton Pump Inhibitors (PPI) could be harmful to the kidneys.
Other than acute interstitial nephritis, the labels have not been modified to list any other possible kidney complications. This has led to a number of PPI lawsuits filed against the manufacturer, alleging failure to provide safety warnings in spite of having knowledge about it and resulted in thousands of individuals using the product for inappropriate indications and for far longer periods of time.
Around 172 lawsuits have been filed in California, Illinois, Kansas, Louisiana, Missouri, New York, Ohio, Tennessee, and West Virginia, etc.
The Judicial Panel on Multidistrict Litigation (JPML) granted the motion to centralize claims against PPIs MDL 2757 in the U.S. District of New Jersey where most of the PPI claims are currently pending to be presided by Judge Claire C. Cecchi.
With more than hundred PPI cases heading towards centralization, it is a brave move by Perrigo to plan the launch in September.
Another recent research work, presented at the annual Digestive Disease Week conference, indicated a link between PPI usage and increased risk for pancreatic cancer.