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FDA warns of heartburn medication side effects

The FDA is warning doctors and patients that popular heartburn drugs like Nexium and Prilosec may cause bone fractures when used for more than a year.

The FDS said several studies have shown increased risk of hip, wrist and spine fractures in patients using drugs that block stomach acid. The agency said a half-dozen studies tracked fractures in patients older than 50 when the drugs were used between one and 12 years.

The agency says the association between the drugs and bone fractions is still not understood and it plans to investigate further.

The drugs are known as proton pump inhibitors and include both prescription drugs like Nexium and Prevacid as well as Prilosec OTC.

From the FDA site:

Additional Information for Patients and Consumers

* Proton pump inhibitors are effective in treating a variety of gastrointestinal disorders. Do not stop taking your proton pump inhibitor unless told to do so by your healthcare professional.
* Be aware that an increased risk of fractures of the hip, wrist, and spine has been reported in some studies of patients using proton pump inhibitors. The greatest increased risk for these fractures was seen in patients who receive high doses of these medications or use them longer (a year or more).
* Read and follow the directions on the OTC Drug Facts label, when considering use of OTC proton pump inhibitors.
* Be aware that the OTC proton pump inhibitors should only be used as directed for 14 days for the treatment of frequent heartburn. If your heartburn continues, talk to your healthcare professional. No more than three 14-day treatment courses should be used in one year.
* Talk to your healthcare professional about any concerns you may have about using proton pump inhibitors.
* Report any side effects with proton pump inhibitors to FDA's MedWatch program using the information at the bottom of the page in the "Contact Us" box.

Full post as published by A Georgia Lawyer on June 01, 2010 (boomark / email).