Our lawyers are investigating possible Nexium bone fracture lawsuits.
Overview of Nexium
Nexium (esomeprazole magnesium), produced by AstraZeneca, is approved by the Federal Drug Administration (FDA) for the treatment of the following conditions: Dyspepsia, Peptic ulcer disease (PUD), Gastroesophageal reflux disease (GERD), Laryngopharyngeal reflux, Barrett’s esophagus, the prevention of stress gastritis, Gastrinomas and other conditions that cause hypersecretion of acid and Zollinger-Ellison syndrome. It can be administered by injection through an IV or can be taken orally as a capsule in twenty or forty milligram dosages which are taken once or twice per day for a period of not more than fourteen days as recommended by the FDA. The medication is now produced by several pharmaceutical companies under the names, Prilosec, Aciphex, Dexilant, Zegrid, Prevacid, and Protonix. Nexium (esomeprazole) is AstraZeneca’s best-selling drug and the third best-selling medication in the world, with over $5.2 billion in sales in 2008.
The medicine belongs to a class of drug called Proton Pump Inhibitors (PHI). Their main function is a pronounced and long-lasting reduction of gastric acid production. This group of drugs followed and has largely replaced the use of H2-receptor antagonists with similar effects, but different mode-of-action. The main difference between the two classes are PPI’s stop proton pumps in the stomach from producing gastric acid, whereas the H2’s block the action of histamine on parietal cells in the stomach, decreasing the production of acid by these cells.
Generally, Nexium and other drugs of this type are well tolerated by patients and adverse effects from short-term use are not very common. Although adverse side effects are reported more often with the use of omeprazole, the same risks apply for all PPI’s. It is believed the occurrence is elevated in the use Nexium and similar medications because they are prescribed more than other PPI’s. Common side effects include: headache, nausea, diarrhea, abdominal pain, fatigue, and dizziness. Long-term use of PPI’s has been linked to hypomagnesemia. Because the body uses gastric acid to release B12 from food particles, decreased vitamin B12 absorption may occur with long-term use of proton-pump inhibitors and may lead to Vitamin B12 deficiency. Infrequent adverse effects include rash, itch, flatulence, constipation, anxiety, and depression. Rarely PPI cause ‘idiosyncratic’ reactions such as erythema multiforme pancreatitis, Stevens Johnson syndrome, and acute interstitial nephritis.
Also, studies have shown using H2-receptor antagonists and proton pump inhibitors, are associated with an increased risk of community-acquired pneumonia. It is suspected that acid suppression results in insufficient elimination of pathogenic organisms, suggesting that patients at higher risk of pneumonia should be prescribed PPI’s only at lower doses and only when necessary. PPIs have been shown to raise risk of Clostridium difficile infection by 1.7 times with once daily use and 2.4 times with more than once daily use. The risk can be minimized by judicious short term prescriptions.
Nexium Hip Fractures
Long-term use of proton pump inhibitors has been less studied. Potential Nexium bone fracture lawsuits are going to need future studies to confirm where plaintiffs’ lawyers think the evidence is going to play out. One thing is for sure that no one needs to study: a hip fracture is an awful thing.
A big lens to the question of whether Nexium causes bone fractures can be found in a huge study of 135,000 people, ages fifty or older, which found that those taking high doses of PPIs for longer than one year have been found to be 2.6 times more likely to break a hip. Those taking smaller doses for one to four years were 1.2 to 1.6 times more likely to break a hip. The risk of a fracture increased with the length of time taking PPIs.
Why Would Nexium Cause Hip Fractures?
The theory as to the relationship between PPI’s and hip fractures is that the reduction of stomach acid reduces the amount of calcium dissolved in the stomach. PPIs may also interfere with the breakdown and rebuilding of bone by intruding upon the acid production of osteoclasts. Also, the reduction of vitamin B12 (by raising homocysteine) may increase bone fragility. It is suggested that these effects may be negated by including 100 mcg of B12 to be taken in conjunction with the PPI.
After the FDA reviewed several long-term studies which reported an increased risk of fractures of the hip, wrist, and spine during treatment with PPI’s, especially in women who smoke or have smoked in the past, the FDA revised both the prescription and the over-the-counter (OTC) labels for PPIs to include notice of the risk of fractures. Some studies found a greater risk for these fractures from higher doses of PPI or use for one year or more. Most studies evaluated individuals aged fifty or older and the increased risk of fractures was primarily in this group.
New FDA Nexium Warning
In May 2010, the FDA issued their original warning as it pertains to the risk of bone fractures. Then about a year after the FDA issued its original warning, researchers, based upon studies dating back to the early 1980’s, reiterated the the fact that risks of bone fractures greatly increased when using PPI’s. Researchers found that women who smoke or used to smoke and regularly took Prilosec, Nexium or another PPI, had a 51% increased risk of suffering a hip fracture. Women who did not smoke only had a 6% increased risk when taking a PPI. Researchers also concluded that the longer the duration of use, the greater the risk of a hip fracture. Scientists also noted a steady decline of hip fracture risk once use of PPI’s was discontinued. In March of this year, the FDA refined its warning to add that the increased risk of fractures appears to be dose-specific.
Nexium “Class Action” Lawsuits
Product liability lawyers are reviewing potential Nexium lawsuits for bone fractures or other bone problems suffered by users of the medication throughout the United States. A lawsuit has been filed against AstraZeneca in Texas by 35 people who allege they suffered bone deterioration or unexpected fractures due to the side effects of Nexium. The Nexium lawsuit was filed in mid-May 2011 against the drug maker and a Houston-area sales manager, alleging that despite knowledge that Nexium could cause bones to deteriorate and break, the medication was sold without adequate warnings for consumers. The Plaintiffs in this action consist of thirty-four women and one nine-year-old boy who allege that they experienced bone problems from Nexium after using the prescription strength for treatment of heartburn, acid reflux, ulcers or inflammation of the esophagus. Ultimately, it is reasonable to expect a “pseudo” Nexium bone fracture class action lawsuit. Although not really a class action in the legal sense, these cases may be consolidated as one for what is called core discovery – the phase of a lawsuit where the facts common to all similar lawsuits would be uncovered.
I find it interesting to learn that the drug companies and the FDA knew of the risk before it was approved to be sold over-the-counter. (Reading AstraZeneca’s internal documents can make for an interesting read. If you ever saw the Seroquel documents, you are nodding your head.)
Getting More Information on Your Potential Nexium Lawsuit
Again, our lawyers are reviewing potential Nexium bone fracture lawsuits. If you think you may have a potential lawsuit, call 800-553-8082 or get a free-online consultation here.