Fosamax for bone strength linked with leg fractures and pain

-The Daily Telegraph

07/26/2008- A bone-strengthening medicine used by more than 210,000 Australians with osteoporosis has been associated with unusual fractures of the thigh bone and severe and debilitating bone and muscle pain.

The drug Fosamax is used to strengthen bone and prevent fractures, but two new studies reported that women who had been using the drug long-term had their thigh bones snap - in some cases while they were doing nothing.

Three doctors from the Weill Cornell Medical College, New York, reported their findings in a letter to the New England Journal of Medicine in March.

Their study involved 15 post-menopausal women who had been using Fosamax for about 5.4 years.

A separate study carried out by doctors at the Singapore General Hospital identified nine women who had used Fosamax long-term who also suffered leg fractures.

Five of the patients had experienced pain in the affected hip in the months preceding the break.

"Our study suggests that prolonged suppression of bone remodelling with alendronate (Fosamax) may be associated with a new form of insufficiency fracture of the femur," the authors said.

"We believe that this finding is important and indicates the need for caution in the long-term use of alendronate in the treatment of osteoporosis."

Subsidies for Fosamax cost the Australian taxpayer more than $113 million a year and it is the ninth most costly drug on our pharmaceutical benefits scheme.

It used to be available only to people with osteoporosis who had sustained a fracture, but 18 months ago became available as a preventative treatment for those aged over 70.

Fosamax works by slowing down the process whereby old bone is removed by the body as new bone grows. This is how it strengthens bone density.

But the US doctors said their study raises the possibility that bisphosphonates (Fosamax) alter bone strength with prolonged use in some people.

Drug company Merck Sharp and Dohme told The Daily Telegraph there had been only 40 of the fractures in question reported worldwide since Fosamax was launched more than 10 years ago.

In controlled clinical trials of the drug on more than 3800 patients who had used the drug for longer than three years, Fosamax has not been associated with increased fracture risk at any skeletal site.

Australia 's drug watchdog, the Therapeutic Goods Administration, recently undertook a review of all available data on Fosamax and patient information on the drug was updated in May to warn of the small risk of fractures.

Support group Osteoporosis Australia said yesterday it was aware of the new studies.

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