The FDA has announced that it is requiring strengthened warnings concerning the possible increased risk of fractures of the hip, wrist, and spine with the use of the class of drugs known as proton pump inhibitors, which includes drugs like Nexium, Prilosec, and Prevacid.
Proton pump inhibitors are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestinal ulcers, esophageal inflammation, and frequent heartburn.
The strengthened warnings will be required for both prescription proton pump inhibitors and over-the-counter (OTC) versions. In addition to the prescription drugs Nexium, Prilosec, and Prevacid, the warnings will be required for other prescription drugs Dexilant, Zegerid, Protonix, Aciphex, and Vimovo, and for OTC drugs Prilosec OTC, Zegerid OTC, and Prevacid 24-Hour.
Although clinical trial data for these drugs that has been gathered to date does not show an increased risk of fractures, the FDA’s decision to require strengthened warnings comes on the heels of its review of seven epidemiological studies that show an increased risk of fractures in older patients, taking higher doses, for a duration of one year or longer.
If you or a loved one has experienced a fracture or broken bone after having taking one of these heartburn medications for a year or longer, contact our firm at http://www.pbmattorneys.com. We will review your case and help determine whether you have a legal claim for your injuries.