FDA Says No "Clear Connection" Between Bisphosphonate Use and Femur Fracture Risk

From Medscape Medical News
Robert Lowes

March 11, 2010 — The US Food and Drug Administration (FDA) announced yesterday that patient taking bisphosphonates should continue to do so, barring any recommendation from their physician, as the agency had no evidence to conclude that the drugs increased the risk for femur fractures just below the hip joint.

The FDA advisory came a day after ABC News cited "mounting evidence" allegedly showing that long-term use of alendronate (Fosamax, Merck), a popular bisphosphonate, or its generic versions could cause spontaneous femur fractures in some women.

"At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures," the FDA stated, adding that it has been working closely with outside experts to investigate the issue. The FDA began their ongoing investigation on this topic in June 2008.

The FDA notes that healthcare professionals should follow the recommendations on the drug label when prescribing bisphosphonates, and adverse events potentially associated with bisphosphonates should be reported to MedWatch, the FDA's safety information and adverse event reporting program.

More information is available on the FDA Web site.

To report adverse events related to bisphosphonates, contact MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.