Nexium® (Esomeprazole Magnesium) Heartburn Relief

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Nexium® Side Effects

FDA Warning: Fractures

The U.S. Food and Drug Administration (FDA) issued a safety announcement stating that proton pump inhibitors such as Nexium® may cause bone fractures.

Proton pump inhibitors like Nexium® work by curtailing the amount of acid made by acid-producing cells in the stomach. The acids aid in the digestion of food, but in some patients the acid backs up into the esophagus, the tube that connects the throat to the stomach. Such a problem, called acid reflux, can erode the walls of the esophagus over time.

Potential Problems Associated with Nexium®

After analyzing the results of a number of epidemiological studies, the FDA warned that Nexium® and similar proton pump inhibitors might be linked to:

Hip fractures
Wrist fractures
Spine fractures

Epidemiological studies take a backwards look at a certain population. Clinical studies take a forward look at a population and offer a better opportunity to get controlled results. One advantage of controlled results is that they can prove a cause and effect relationship between a medication and a patient population. Epidemiological studies can show an association between the drug and a particular effect, but not necessarily a cause and effect.

The FDA plans to review the results of long-term controlled clinical trials to determine the risk of fractures in women taking fracture-preventing medications and the affect of Nexium®.

Drug Interactions

In addition to the possibility that Nexium® causes bone fractures, Nexium® and similar drugs may have an undesired effect on medications taken by HIV patients. The FDA cautions physicians prescribing Nexium® and related drugs to be alert to such potential side effects. The agency also is updating the label accompanying over-the-counter medications to warn of potential Nexium® side effects.

Other problems associated with Nexium® include adverse interactions with other drugs the patient might be taking. These include medications to treat HIV, Coumadin™, and drugs where the acidity of the stomach is important, including Ketoconazole, Iron salts and Digoxin.