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Proton pump inhibitors cover a range of prescription and over-the-counter (OTC) medications for controlling heartburn, gastro-esophageal reflex disease (GERD), ulcers in the stomach and small intestines, and inflammation of the esophagus. Life-threatening side effects, such as an increased risk of fractures to the hip, wrist, and spine, have resulted in an FDA warning and multiple lawsuits.
Background
PPIs go by such common names as Nexium, Dexilant, Prevacid, Prilosec, Zegerid Protonix, Aciphex, and Vimovo and have been on the market for a number of years. Because of their common usage, PPIs generate $13.9 billion in annual sales for about 113.4 million prescriptions per year.
However, while PPIs reduce stomach acid, they’re said to prevent the body from absorbing calcium, resulting in osteoporosis.
Studies correlating increased fracture risks with PPI usage date back to 2006. One from the University of Pennsylvania, published in the Journal of the American Medical Association, found that patients over 50 years of age have a 14-percent greater risk of hip fractures. Risk increases with dosage, with men and people who’ve taken PPIs for over five years more susceptible to potential fractures. Following this, a 2008 study published in the Canadian Medical Journal confirmed the initial findings.
A third study, from the May 2010 issue of the Archives of Internal Medicine, observed 145,000 people, all of whom used a PPI for a year or longer. People who took a PPI had a 44-percent greater chance of hip fractures than those who didn’t take it. As well, the chance doubled for those taking a high dosage for a year or longer.
Another study spurred the FDA to take action. Analysts looked at a computer database over six months, examining patients who took a PPI for one to 12 years. Older individuals, this study found, are at a greater risk for fractures.
In response, the FDA put out a warning in 2010, specifying greater fracture risks for patients over 50 years of age. As well, OTC and prescription labels were revised, with the former specifying usage no longer than 14 days.
Other Side Effects
PPIs are associated with multiple lower-level side effects, such as muscle spasms, irregular heartbeat, seizures, and hypomagnesemia, a condition resulting from low magnesium in the blood.
The latter condition has been reported in patients taking PPIs for three months or longer, and in response, the FDA required manufacturers in 2011 to include this risk on drug labels. Now, healthcare providers must take a patient’s magnesium levels and to determine, first, if he or she is already taking a drug, such as a diuretic, that could lower magnesium levels in the blood. If the condition emerges, patients must stop the PPI and start taking a supplement.
As well, PPIs are said to interfere with the effectiveness of Plavix, decreasing it up to 47 percent. Studies have found combined usage increases the risk of a serious cardiac event after a heart attack. Specifically, there’s a 29-percent increase of re-hospitalization for another cardiac event 30 days after discharge, compared to patients not taking a PPI.
