NEXIUM BONE FRACTURE LAWSUIT

Our lawyers are vigorously investigating potential Nexium® bone fracture lawsuits.

An Overview of Nexium

Nexium® (esomeprazole magnesium) is a drug manufactured and distributed by AstraZeneca.  It was approved by the Food and Drug Administration (FDA) in February 2001, for the treatment of numerous stomach conditions such the following:

• Dyspepsia (upset stomach, indigestion, impaired digestion);
• Peptic Ulcer Disease (PUD);
• Gastroesophageal Reflux Disease (GERD);
• Laryngopharyngeal Reflux (LPR), also known as Extraesophageal Reflux Disease (EERD);
• Barrett’s Esophagus (pre-cancerous condition where normal cells in the lining of the esophagus develop into abnormal cells which can lead to adenocarcinoma (esophageal cancer);
• Prevention of stress gastritis (type of ulcer caused by stress);
• Adenocarcinoma (cancer of the esophagus);
• Zollinger-Ellison Syndrom (gastric acid hypersecretion, severe peptic ulceration, and non-beta cell islet tumor of pancreas (gastrinoma); and
• Other forms of hypersecretion of stomach acid

Nexium is most readily available in capsule form of twenty to forty milligram dosages and is taken once or twice per day depending on doctor’s instructions for a period of no more than fourteen days.  It may be administered for longer periods of time pursuant to doctor’s instruction.  It is also less commonly available as an injection administered intravenously.  Nexium is AstraZeneca’s best-selling drug and the third best-selling medication in the world generating over $5.2 billion in sales in 2008.  Esomeprazole is now produced by several pharmaceutical companies under the brand names Prilosec, Aciphex, Dexilant, Zegrid, Prevacid, and Protonics, as well as its generic formulation, Omeprazole.

The medication belongs to a class of drug called Proton Pump Inhibitors (PPI) which is designed to cause a pronounced and long-lasting reduction in gastric acid.  It has more or less replaced the use of H2 Receptor Antagonists which has the same results, but does so in a different mode of action.  The main difference between the two classes is the PPI’s stop the production of gastric acid, whereas the H2-type drugs block the action of histamine on parietal cells (outer lining) in the stomach which decreased the production of acid by these cells.

Nexium and other drugs belonging to this class generally are well tolerated by patients and serious adverse effects from short-term use of the medication are rare.  The common side effects are headache, nausea, diarrhea, abdominal pain, fatigue and dizziness.  Adverse effects of omeprazole, although all PPI’s carry the same risks, are reported more often than other PPI’s mainly due to the fact that it is prescribed more often than other PPI’s.

Adverse Side Effects

Long-term use of Proton Pump Inhibitors has been linked to hypomagnesaemia, an electrolyte disturbance in which there is an abnormally low level of magnesium in the blood.  The body uses its gastric acid to release Vitamin B-12 into the blood and because PPI’s inhibit the production of stomach acid, it is believed its use on a long-term basis can lead to a deficiency in B-12. Infrequently, adverse side effects such as rash, itch, flatulence, constipation, anxiety, and depression are reported.  Idiosyncratic reactions such as erythema multiforme (redness of the skin, caused by hyperemia of the capillaries in the lower layers of the skin), pancreatitis, Stevens - Johnson syndrome (a potentially deadly skin disease), and Acute Interstitial Nephritis are reported, but occur rarely.

Also, studies have shown that long-term use of H2-receptor Antagonists and Proton Pump Inhibitors are associated with an increased risk of community-acquired pneumonia.  Researchers suspect that the suppression of gastric acid causes an insufficient elimination of pathogenic organisms.  Therefore, patients who fall in the high-risk category for pneumonia should only be prescribed PPI’s, and like medications, at lower dosages and for as short of a time as possible, and only when necessary. The medicine also has shown to raise the risk of Clostridium difficile infection (bacterium associated with Colitis), by 1.7 times for those patients who are administered the medication once daily and by 2.4 times in those who take the medication twice daily.

Nexium Hip Fractures

Long-term use of PPI’s has been less studied; therefore, potential bone fractures caused by Nexium and lawsuits stemming from such adverse effects are going to require future studies to affirm where Plaintiffs’ attorneys believe the evidence is going to play out.  One thing is for certain and requires no further evidence:   a hip fracture is an awful thing. 

A big lens to the question of whether or not Nexium causes bone fractures can be found by reviewing a very large study of 135, 000 people, ages fifty and older which found those taking high doses of Nexium for longer than one year are 2.6 times more likely to break a hip.  Patients taking smaller doses for one to four years were 1.2 to 1.6 times more likely to suffer a broken hip.  The risk of fracture increased in conjunction with the length of time the medication was taken.

Why does Nexium Cause Hip Fractures?

Researchers theorize that the relationship between PPI’s and hip fractures is due to the reduction of acid in the stomach which reduces the amount of calcium dissolved in the stomach and absorbed into the body.  They may also interfere with the body’s ability to break down and rebuild bone by its intrusion upon the acid production of osteoclasts.  Also, the reduction of B-12 by raising homocysteine, may increase bones’ fragility.  It is suggested that this reaction may be negated by adding 100 mcg of B-12 to be taken in conjunction with the PPI.

Original FDA Warning

The FDA’s review of several long-term studies which reported an increased risk of hip, wrist, and spine fractures during treatment with PPI’s, especially women who smoke or have smoked in the past, prompted the agency to revise labeling requirements for both the prescription and over-the-counter (OTC) preparations to include notice of the risk of fractures.  Some studies indicate these fractures occur more often in those who use the medication for more than one year at a higher dose, keeping in mind that most people involved in the studies were ages fifty and older; thus, the increase in risk of fractures occurred primarily in that group.

New FDA Nexium Warning

In May 2010, the FDA issued their original warning.  Then approximately one year later, researchers, based upon studies dating back to the early 1980’s, reiterated the fact that the risk of bone fractures greatly increased when using PPI’s.  Scientists found that women who smoke or have smoked in the past who regularly used Nexium or another PPI such as Prilosec (also produced by AstraZeneca) had a fifty-one percent increased risk of suffering a hip fracture.  Alternately, women who did not smoke only had a six percent increased risk while taking PPI’s.  Researchers also concluded that the longer the duration of use, the greater the risk of fracture.  However, a steady decline in the risk of fractures was noted once the patient discontinued use of the PPI.  In March of this year, the FDA further refined its warning to add that the increase in risk appears to be dose-specific.

Nexium Class-Action Lawsuits

Product Liability attorneys continue to review 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 thirty-five people who allege they suffered bone deterioration or unexpected fractures due to the side effects of Nexium.  The lawsuit was filed in mid-May this year against the drug’s manufacturer and a Houston-are salesperson claiming that despite knowledge the drug could cause bones to deteriorate and break, the medication was sold without adequate warnings to the consumers.  The Plaintiff’s in this action consist of thirty-four women and one nine year old boy who claim they experienced bone problems from Nexium after using the prescription strength for the treatment of heart burn, 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 common facts 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 saw the Seroquel documents, you are nodding your head.)

What You Should Do?

Our attorneys are reviewing potential Nexium bone fracture lawsuits.  If you think you may have a potential lawsuit.  Please call 1-800-553-8082 or get a free online consultation here.