Product Liability

FDA panel says not enough data to limit osteoporosis drug use

A federal advisory panel said Sept. 9 that it does not have enough data to make recommendations about whether a class of drugs used to treat osteoporosis should not be used long-term. The panel was convened by the Food and Drug Administration (FDA) to review data on medications known as bisphosphonates, and data that suggests long-term use of the drugs put women at risk for a rare type of thigh fracture.

Bisphosphonates include brand-name prescription drugs Fosamax, Actoenl, Boniva, and Reclast. When they were first developed, it was thought to be a drug women could take indefinitely to treat low bone density and help ward off osteoporosis. The first red flags arose when Fosamax was linked to a rare bone decay known as osteonecrosis of the jaw, or ONJ. It was just the beginning.

In October 2010, following a review of more data on the safety of bisphosphonates, the FDA required all manufacturers of the drugs to add warnings to their safety labels for the risk of thigh fractures, specifically low-energy femoral shaft and subtrochanteric fractures.

Just two weeks ago, the drug Reclast received a new warning about a potentially deadly kidney impairment associated with using the medication. This new warning was required after the FDA received reports of acute renal failure requiring dialysis or causing death following Reclast treatment.

Despite the risks seen with the drugs, the FDA panel fell short of limiting the drug, citing its benefits with treating osteoporisis by lowering the risk of hip and other types of fractures commonly seen with the disease. The panel instead voted to recommend that the drug’s label be updated to advise doctors to evaluate patients over time in order to determine whether treatment with bisphosphonates should be stopped.

New York Times
Beasley Allen Fosamax & ONJ