Generic Zegerid Approved, Despite Concerns Over Possible Proton Pump Inhibitor Side Effects

Published on July 20, 2016 by Sandy Liebhard

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The U.S. Food & Drug Administration (FDA) has approved generic versions of Zegerid and Zegerid OTC, despite concerns regarding the health risks potentially associated with proton pump inhibitors. Among other things, recent studies have suggested that long-term use of the popular heart burn medications may be associated with an increased risk of chronic kidney disease and kidney failure.

What is Zegerid?

Zegerid contains both omeprazole (the active ingredient in Prilosec) and an antacid called sodium bicarbonate. The prescription version is indicated for the short-term treatment of active benign gastric ulcer, active duodenal ulcer, erosive esophagitis (EE); symptomatic GERD; and the maintenance of healing of EE. Zegerid OTC is approved for thee treatment of frequent heartburn occurring ≥2 days per week.

The newly-approved generic version of Zegerid is being marketed by Dr. Reddy in 20mg/1100mg strength, while Perrigo will market the generic brand of Zegerid OTC in 20mg/1100mg and 40mg/1100mg strengths. Shipment of the products has already commenced.

Proton Pump Inhibitor Side Effects

Proton pump inhibitors include prescription medications such as Nexium, Prilosec and PrevAcid. Over-the-counter versions, including Nexium 24Hr, are also available. Both prescription and over-the-counter brands are extremely popular, and are used by millions of people to relieve symptoms associated with GERD and other conditions caused by the excess production of stomach acid. However, there is concern that many patients are taking these drugs for longer periods of time than what is actually recommended.

The long-term use of proton pump inhibitors has been linked to serious complications, including hypomagnesemia, increased risk of C. diff, certain bone fractures, and B12 deficiency. Two studies published this year also suggested that extended use of the drugs could increase a patient’s risk for chronic kidney disease and kidney failure. Additional studies have pointed to links with heart attacks, dementia and accelerated blood vessel aging.

Proton Pump Inhibitor Lawsuits

Since the publication of studies linking the use of drugs like Nexium to renal failure and chronic kidney disease, a number of proton pump inhibitor lawsuits have been filed in U.S. courts. Considering the popularity of these drugs, it is likely that more cases will be filed in the comings months and years.

Bernstein Liebhard LLP offers free legal reviews to individuals who suffered kidney problems allegedly related to the use of Nexium and other proton pump inhibitors. To learn more, please call (888) 994-8177.

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