<"https://www.yourlawyer.com/topics/overview/Proton_pump_inhibitors">Proton Pump Inhibitors (PPIs) have provided relief to thousands of people suffering from chronic heart burn and other stomach problems. Bit it now appears these drugs might be associated with a increased risk of certain fractures, especially when they are used by older women over a long period of time.
PPIs are a class of drugs that include the prescription medications Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, and Vimivo. They also include over-the-counter (OTC) versions like Prilosec OTC, Zegerid OTC and Prevacid 24HR.
PPIs are extremely popular. Each year doctors write about 113.4 million prescriptions for PPIs to treat conditions like gastroesophageal reflux disease (GERD), stomach ulcers and other disorders. Meanwhile, the OTC PPI market in the U.S. is estimated to be worth around $1.7 billion.
In May, the U.S. Food & Drug Administration (FDA) announced it was revising the safety labeling for both OTC and prescription PPIs to warn that they might be associated with a higher risk of hip, wrist and spine factures. The agency advised that healthcare professionals and users of PPIs be aware of the possible increased risk of fractures of the hip, wrist, and spine and weigh the known benefits against the potential risks when deciding to use them.
The new safety information was based on the FDAâ€™s review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist, and spine with PPI use. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. Some studies found that those at greatest risk for these fractures received high doses of PPIs or used them for one year or more.
At the present time, the FDA said there is uncertainty about the magnitude of this risk. In light of this uncertainty, when prescribing proton pump inhibitors, healthcare professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition, the agency said.