Dexilant Increased Risk Of Bone Fractures. Dexilant (dexlansoprazole), a proton pump inhibitor, may be related to an increased risk of bone fractures, especially those involving the hip, spine, or wrist. In May 2010, the U.S. Food & Drug Administration (FDA) issued a safety alert warning that Dexilant and other proton pump inhibitors had been associated with an increased risk of bone fractures. Since the FDA issued its May 2010 fracture warning, victims of Dexilant and other proton pump inhibitors have filed lawsuits seeking compensation for fractures of the hip, spine and wrist, as well as broken ribs, ankles and feet.
If you suffered a broken bone while using Dexilant, you may be entitled to compensation. Our Dexilant lawyers are offering free lawsuit consultations to victims of Dexilant bone fractures. To find out more about filing a Dexilant lawsuit, we urge you to contact us today to ensure that your legal rights are protected.
Dexilant is used to treat persistent heartburn related to acid reflux disease. It is also prescribed to heal acid-related damage to the lining of the esophagus. Dexilant was at one time sold under the name Kapidex. The drug’s name was changed in 2010 due to reports of dispensing errors caused by confusion with the drugs Casodex and Kadian.
In May 2010, the FDA announced that information about a potential risk of fractures was being added to the labels of all prescription proton pump inhibitors after a review of several epidemiological studies reported an increased risk of fractures of the hip, wrist, and spine. Six studies reported an increased risk for fracture with proton pump inhibitor use. In addition, 2 studies showed such an increased risk with a higher dose of the drugs, while 2 studies reported a greater risk with longer duration of use.
“The majority of the studies evaluated individuals 50 years of age and older and the increased risk of fracture primarily was observed in this group,” the FDA stated in its Drug Safety Communication.
In its safety alert, the FDA said doctors and patients should weigh the known benefits of drugs like Dexilant against their potential risks.
Proton Pump Inhibitors and Hypomagnesemia
The long-term use of proton pump inhibitors has been associated with hypomagnesemia, a condition caused by low levels of magnesium in the blood. In March 2011, the U.S. Food & Drug Administration (FDA) mandated that the makers of prescription proton pump inhibitors include information about the potential risk of low magnesium in the WARNINGS AND PRECAUTIONS sections of the labels for all prescription proton pump inhibitors. Proton pump inhibitors subjected to the new warnings included: Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, AcipHex, and Vimovo.
Low serum magnesium levels can result in serious adverse events including:
- Muscle spasm
- Arrhythmias (irregular heartbeat)
According to the FDA, hypomagnesemia has been reported in adult patients taking proton pump inhibitors for at least three months, but most cases occurred after a year of treatment. Approximately one-quarter of these cases required discontinuation of proton pump inhibitor treatment in addition to magnesium supplementation. It is not understood why long-term proton pump inhibitor treatment sometimes results in hypomagnesemia. The FDA has recommended that healthcare providers consider obtaining serum magnesium levels before their patients begin treatment with prescription proto pump inhibitors. The agency said they should also consider periodic testing if patients are also being treated with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. In digoxin patients especially, low magnesium can increase the likelihood of serious side effects.