Nexium 24HR continues to rank as the top-selling over-the-counter gastrointestinal drug, with sales of more than $313 million for the 52-week period ending July 10, 2016. However, a new report from DrugStoreNews.com suggests that the popular heartburn medication could soon have some new competition, as at least one private-label version could become available in 2017.
Nexium 24HR belongs to a class of medications called proton pump inhibitors. The over-the-counter brand was launched in 2004, just three years after the prescription version of Nexium was approved by the U.S. Food & Drug Administration.
Another proton pump inhibitor, Prilosec OTC, holds the number two spot for over-the-counter gastrointestinal brands. It logged sales of more than $254 million for the year ending July 10th. The H2-blocker Zantac 150 ranked as the third best-selling over-the-counter antacid.
DrugStoreNews.com noted that the market exclusivity period for Nexium 24HR will expire in March 2017. That will likely spark a new wave of private-label competition, as generic drug maker Perrigo has already secured a tentative approval from the FDA for its Nexium 24HR equivalent. The company’s CEO recently told investors that it plans to launch its product soon after the exclusivity period runs out on the name-brand drug.
The continued popularity of proton pump inhibitors like Nexium and Nexium 24HR is helping to drive safety concerns, as recent studies have suggested that these medications may be associated with a variety of serious side effects. In January, for example, research published in JAMA Internal Medicine suggested that extended use of the drugs might increase a patient’s risk for chronic kidney disease by as much as 50%. And this past April, a study conducted by researchers at the Department of Veterans Affairs indicated that proton pump inhibitors were associated with a 96% higher risk of kidney failure, as well as a 28% greater risk of chronic kidney disease, after five years of use.
Other recent studies have suggested that long-term use of proton pump inhibitors may increase the likelihood of heart attacks and dementia. Other side effects potentially associated with the drugs include acute interstitial nephritis (kidney inflammation), certain bone fractures, low magnesium levels and B12 deficiency.
A report that aired on NPR in February noted that there is concern that many patients are overusing proton pump inhibitors like Nexium. One doctor interviewed suggested that many people could find relief via lifestyle changes, including weight loss and the avoidance of fatty foods. The report also noted that proton pump inhibitors are intended to be used for short periods of time, though many people take the drugs far longer that what is necessary.