AstraZeneca manufactures and sells Nexium throughout the world. Nexium is one of a class of drugs called proton-pump inhibitors (“PPIs”). PPIs are primarily used in the treatment of gastroesophageal reflux disease (“GERD” or “acid reflux disease”). The manifestation of acid reflux in patients is usually either heartburn or erosive esophagitis (“EE”), which is damage to the lining of the esophagus.
Nexium is a big winner for AstraZeneca who also has Prilosec (omeprazole) – the pioneer PPI – in its arsenal as well. Suffice it to say, AstraZeneca has a lot of money riding on the success of its PPIs.
In the past, AstraZeneca has come under attack from critics who complained that Nexium advertising was misleading because it wrongfully claimed that Nexium was a big improvement over Prilosec because in clinical trials there was a 2-to-1 ratio in the dosage of Nexium to Prilosec. In hindsight – and maybe even at the time – who cares?
But now we have a bigger problem. Suits have been filed around the country against AstraZeneca alleging serious bone problems – including fractures – were caused by the use of Nexium and Prilosec. Researchers did what epidemiologists call a meta-analysis of 11 studies published between 1997 and 2011. They found that PPIs like Nexium and Prilosec were associated with a 29 percent increased risk of fracture. There is more disturbing data on more serious injury fractures: a 31 percent higher risk of hip fractures and a 54 percent heightened risk of vertebral fractures.
Why are Nexium, Prilosec and other PPIs causing bone problems? The theory as to the relationship between PPIs 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 PPIs 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.
The FDA updated its Nexium fracture warning in March telling doctors and patients that the risk of broken bones appears to be linked to high doses PPIs over a long period of time.
Our lawyers are reviewing potential Prilosec and Nexium lawsuits. We are looking specifically at bone fracture lawsuits involving either of these drugs. If you think you may have a potential lawsuit, call 800-553-8082 or get a free online consultation here.