FDA issues reminder of risks of spinal-fracture treatment
Thursday, April 3rd 2003, 12:00 am
By: News On 6
WASHINGTON (AP) _ Injecting a special glue into osteoporosis-caused spinal fractures is a pain-easing treatment growing in popularity, but the government is reminding doctors that it may be linked to serious and occasionally life-threatening side effects.
Bone-thinning osteoporosis can cause people to lose height and suffer serious pain as their vertebrae crack. Using procedures called vertebroplasty or kyphoplasty, doctors can stabilize or even prop back up the crushed bone with injections of bone cement.
The Food and Drug Administration has never approved that specific use of bone cement, although the procedures have been increasingly offered since the late 1990s.
Orthopedic surgeons long have known the cement can sometimes leak, posing a risk.
Since 1998, the FDA has received reports of 45 patients who suffered serious complications associated with the procedures: severe nerve pain, blood clots in the lungs, intestinal blockage, and respiratory or cardiac failure. Five of those people died.
The FDA cannot say how often such complications occur; studies of the procedures are under way.
But, noting that doctors other than orthopedic surgeons who may not be as familiar with leaking cement now widely offer the procedures, the FDA posted on its Web site this week a reminder to monitor patients for the complications.
Patients considering the spinal treatments should be aware of the potential side effects, said Laura Alonge of FDA's medical device division.
``This is a way they can discuss with their doctors whether they are more at risk for some of these complications than someone else, and decide if they want to go that route for relief of their back pain,'' she said.