FDA has a fractured bone to pick with long-term ulcer drugs

By ACSH Staff — Mar 24, 2011
For those over the age of 50 taking prescription proton pump inhibitors (PPIs), the FDA warns that using these medications for over a year increases the risk of bone fractures. New labels will be issued for drugs like Nexium, Prilosec and Prevacid that include new safety information about the increased risk of bone fractures of the hip, wrist and spine associated with the long-term use of PPIs. Short-term, low-dose use of the drugs, used to treat ulcers, acid reflux or other conditions, is not likely to pose a risk for fracture.

For those over the age of 50 taking prescription proton pump inhibitors (PPIs), the FDA warns that using these medications for over a year increases the risk of bone fractures. New labels will be issued for drugs like Nexium, Prilosec and Prevacid that include new safety information about the increased risk of bone fractures of the hip, wrist and spine associated with the long-term use of PPIs. Short-term, low-dose use of the drugs, used to treat ulcers, acid reflux or other conditions, is not likely to pose a risk for fracture. Though over-the-counter PPIs are specifically marketed for 14-day intervals no more than three times a year, some people may take them beyond the indicated use.

When asked about the new FDA warning, ACSH's Dr. Gilbert Ross comments that, “I don't think it’s a huge deal, but there are a lot of people taking these drugs, and some may be using the over-the-counter PPIs long term. But I should reiterate the new warning really only applies to chronic users who are over the age of 50, especially those with risk factors for osteoporosis.”

According to ACSH’s Dr. Josh Bloom, “this is kind of old news. The connection between PPIs and fractures has been known for a while. Hopefully the new advisory will bring this to the attention of those previously unaware of the effects.”