Tuesday 19 October 2010

Osteoporosis drugs to carry fracture risk warning in US

US regulators are warning patients that drugs used to protect brittle bones may increase fracture risk in rare cases.

The Food and Drugs Administration (FDA) says all drugs in the bisphosphonate class must carry an alert on their label about this unusual side effect.

They say patients should keep taking the pills unless they are told by their doctor to stop.

In the UK, only one bisphosphonate drug - alendronate - carries the warning but regulators are reviewing this decision.

Nearly three million people in the UK have osteoporosis, a condition that makes the bones brittle and causes about 230,000 fractures a year.

Bisphosphonates are given to more than half a million of these patients in a bid to strengthen their bones and reduce their risk of a fracture.

But experts are becoming increasingly concerned that the drugs may cause the very thing they are trying to prevent after finding a link between their use and an unusual type of leg fracture.
A spokesman for the National Osteoporosis Society

The FDA says it is not clear whether bisphosphonates are the cause of these thigh bone breaks, but they are concerned enough to tell manufacturers to add warnings to medication packets.

FDA medical officer Theresa Kehoe said they would continue to monitor the safety of the drugs, adding: "In the interim, it's important for patients and health care professionals to have all the safety information available when determining the best course of treatment for osteoporosis."

The FDA says patients should keep taking their medication unless they are advised by their doctor to stop.