Nexium, Other Heartburn Drugs Commonly Overprescribed: Study

Doctors often prescribe heartburn drugs like Nexium to patients at doses that are too high and keep them on the medications for too long, according to the findings of new research that raises concerns about whether this may increase the risk of individuals suffering certain side effects. 

In a study published Journal of General Internal Medicine, researchers from Northwestern University found rampant over-prescription of proton pump inhibitors (PPI), which includes blockbuster medications like Nexium, Prilosec, Prevacid, Protonix and others.

The large doses and extended usage may leave patients even more open to heartburn drug side effects, which could increase the risk of bone fractures, infections and other problems.

PPIs reduce the amount of acid in the stomach and are used to treat gastroesophageal reflux disease (GERD), as well as heartburn, ulcers in the stomach and small intestines, as well as inflammation of the esophagus. Nexium is the most widely used medication fro this class, with more than $6 billion in annual sales.

Heartburn Drugs Meant To Be Used Short-Term In Low Doses

PPI medications are supposed to be prescribed at the lowest effective dose for four to eight weeks, according to the researchers. If they do not alleviate the symptoms in that time, the physician should look for another possible cause and investigate different types of treatments.

However, researchers indicate that is not what happens in many cases. The study involved a review of data involving 1,600 veterans who had been diagnosed with gastroesophageal reflux disease (GERD) at the Veterans Affairs Hospital in Hines, Illinois. Researchers found that 23.3% of the veterans were prescribed high doses right from the start and were then kept on the pills for 90 days or longer. The researchers also found that 83.8% of the patients received at least one refill. Many are on the drugs for more than two years.

“These results draw attention to the main problem plaguing this highly effective class of medications: once patients are on PPIs, they tend to stay on them,” the researchers concluded. “While the reasons for this are manifold, research suggests that many of these prescriptions are unnecessary, and physicians all too often fail to assess the necessity of continued use.”

Long-term Nexium Use Linked to Bone Fracture Risk, Other Side Effects

Long-term use of PPIs like Nexim have been linked to a number of side effects including infections, bone fractures and an increased risk of pneumonia.

According to a study published in the American Journal of Gastroenterology in July 2012, long-term use of proton pump inhibitors was associated with a 69% increased risk of contracting a clostridium difficile-associated diarrhea (CDAD) infection.

In February 2012, the FDA alerted health care workers that patients who experience diarrhea while taking Nexium, Prilosec or another PPI, which  does not improve, could be suffering from CDAD and said that new warning labels for all PPIs were in development.

In another study in late 2010, South Korean researchers determined that taking PPIs increase the risk of pneumonia by as much as 27%.

The FDA forced the manufacturers of Nexium and all other proton pump inhibitor (PPI) medications to update the warning labels in 2010, adding information about a potential risk of risk of fractures and bone problems associated with use of the medications.

That warning was updated again by the FDA in 2011, indicating that the risk of broken bones from Nexium appears to be linked to high doses of the medication used over long periods of time, which is exactly the kind of prescribing behavior the study found happens far too often.  Over-the-counter versions of the drug did not appear to be affected, according to federal drug regulators.

A number of former users who have suffered bone fractures are now pursuing a Nexium Lawsuit, alleging that AstraZeneca failed to adequately warn about the risks associated with long term use of the heartburn drug.

In December 2012, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established a Nexium bone fracture MDL, consolidating at least 39 injury lawsuits filed in U.S. District Courts throughout the United States.  Many of those complaints also contain a large number of individual plaintiffs, and many expect the Nexium litigation to quickly grow in the coming months.