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FDA Safety Announcement

The U.S. Food and Drug Administration (FDA) has released a safety announcement saying it is revising the labels for a category of heartburn medications called proton pump inhibitors (PPIs). The new label warns that using these drugs could possibly increase a patient’s risk of fractures of the hip, wrist and spine.

Prescription PPIs Include:

• Nexium®
• Prevacid®
• Dexilant™
• Prilosec®®
• Zegerid®
• Protonix®
• Aciphex®
• Vimovo™

The warning also applies to over-the-counter drugs Prilosec®® OTC, Zegerid® OTC and Prevacid® 24HR.

The greatest risk of fractures occurs in patients who have been taking high doses of PPIs or who have been taking them for longer than a year. The FDA is requiring that the “Drug Facts” label on prescription drugs make note of this information.

The FDA is also advising health care providers to consider prescribing a lower dose or keeping their patients on the medication for a shorter period of time if these adjustments might still solve the problems of excess acid produced in the stomach.

PPI medications are used to treat:

• Heartburn
• Stomach ulcers
• Intestinal ulcers
• Inflammation of the esophagus (the tube connecting the stomach and the mouth)
• Esophageal reflux

Esophageal reflux occurs when the acid and some contents of the stomach back up into the esophagus. PPIs work by decreasing the amount of acid made in the acid-producing cells of the stomach.

Hip Fractures in Nexium® Users

Fractures of the hip in adults can have devastating results. About 15 to 20 percent of hip fracture victims die within a year of the fracture. Continuous pain and limited ability to get around are serious consequences of the condition.

The causes of death after a hip fracture often are infection, blood clots or pneumonia. Many hip fracture victims require long-term nursing care or recovery in a rehabilitation unit. Hip fractures followed by death are most common among the elderly. Older adults are among the most frequent users of PPIs.

The FDA based its warning on a review of numerous epidemiologic studies, that is, backward-looking studies of certain population groups. Such studies can usually show links, but not necessarily establish a cause and effect relationship between an agent and a resulting condition. The agency plans to assess controlled clinical studies of the medications.

The government agency qualified its announcement by saying the studies did not take into account situations such as family history of osteoporosis, smoking, use of alcohol or dietary supplements, among a number of factors that could influence the results. It also said it is not known how PPIs might lead to bone fractures.

Speak to a Lawyer about a Bone Fracture Case

If you or a loved one has suffered a hip fracture or another bone fracture and have a history of taking Nexium® or another similar drug, you may want to speak with an experienced attorney to find out if you should file a Nexium® lawsuit to recover compensation. To speak with a Nexium® attorney about your circumstances, contact us today.