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The U.S. Food and Drug Administration (FDA) issued a safety announcement May 25, 2010, that it was revising the labels of proton pump inhibitors (PPIs). The warning alerted patients that this class of drugs, including Prilosec®, may increase the risk of wrist fractures, hip fractures and spine fractures.

PPIs, a class of medications that includes Prilosec®, are drugs to treat:

• frequent heart burn
• acid reflux disease
• ulcers of the lining of the stomach and small intestine
• inflammation of the esophagus

They also are used in combination with antibiotics to treat H. Pylori, a bacterial infection in the stomach that can lead to ulcers. These medications are called proton pump inhibitors because they inhibit the activity of the stomach’s acid-producing cells, known as proton pumps.

The safety announcement released by the FDA warned health care professionals and patients that people taking PPIs were at increased risk of bone fractures, including fractures of the wrist. The advisory reminded users and their doctors to weigh the known benefits of the PPIs against these risks.

Does Prilosec® Cause Other Bone Fractures?

The answer is yes. In addition to increasing the risk of getting fractures of the wrist, it has been reported that the medication may also increase the risk of patients having fractures of the hip and the spine.

Prescription PPIs include:

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

Non-prescription or over-the-counter (OTC) PPIs include:

• Prilosec® OTC
• Zegerid® OTC
• Prevacid® 24 HR

Most of the studies upon which the FDA announcement were based involved persons age 50 or older. The increased risk of fracture occurred primarily in these older persons. Taking the medication for a prolonged period of time (for at least one year) or taking higher doses (which are available only by prescription) also increases the risk of fractures.

The FDA safety communication said that PPIs are effective in treating gastrointestinal disorders and warned patients not to stop taking the medication without talking with their doctors. It advised users not to take over-the-counter PPIs for more than 14 days in a row, or for more than three 14-day treatment periods in one year.

Contact a Prilosec® Attorney

If you have had a fracture of the wrist, hip, or spine after taking Prilosec®, you should contact a Prilosec® attorney. An attorney experienced in these specific cases may be able to help you get the financial compensation you deserve for your suffering. Contact us for more information or to schedule a case evaluation.