Last month, an Arizona woman sued the makers of five prescription-strength antacids, alleging that her long-term use of the drugs caused her to sustain multiple bone fractures in her feet. A few months ago, litigation in Texas alleged that 35 people suffered deterioration of bones and fractures resulting from side effects of Nexium, known as PPI’s, or proton pump inhibitors. Other drugs in the class include Prilosec, Prevacid, Aciphex and Vimovo. The plaintiff party is made of 34 women and one 9 year-old boy who all allegedly suffered bone issues after using Nexium.
PPI’s are also available in over-the-counter (OTC) versions like Prilosec OTC, Zegerid OTC and Prevacid 24 HR. These drugs are approved to treat conditions like heartburn, ulcers, acid reflux, and esophageal reflux disease (GERD), and other disorders.
In May 2010, the Food and Drug Administration (FDA) determined that Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix and Aciphex might include a warning on their labels regarding the possibility of fracture risk, stating proton pump inhibitors (PPIs) may interfere with the ability of our digestive tracts to absorb calcium. In September, The New York Times ran an article stating that some medications, including PPIs, may increase our risk for bone loss and hip fracture. Prilosec, Prevacid and Nexium (medications primarily recommended to treat gastroesophageal reflux symptoms and other conditions resulting from excess stomach acid) were listed.
Further backing the concerns of U.S. health care officials, there is new Korean research (published in the May/June issue of the Journal Annals of Family Medicine) that confirms the long-term use of PPIs is linked to an increased fracture risk.
The FDA’s review of several long-term studies, which reported an increased risk of hip, wrist, and spine fractures during treatment with PPI’s, promted the agency to revise labeling requirements for both the prescription and over-the-counter preparations to include warning of the risk of fracture.
Scientists found that women who smoke or have smoked in the past, who regularly used Nexium or another PPI, such as Prilosec, had a fifty-one percent increased risk of suffering a hip fracture. Some studies indicate that these fractures occur more often in those who use the medication for more than one year at a higher dose. Most of the people who took part in the study were age fifty and older; thus, the increase in risk of fractures occurred primarily in that group.
It is difficult to learn that the drug companies, as well as the FDA, knew about this risk before it was approved to be sold over-the-counter, making it available to millions of Americans. Is this justice?