Naureen Aqueel

Osteoporosis drug linked to rare thigh bone fracture

Posted on: November 27, 2012

Published in The Ward, Nov 27, 2012.

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Another osteoporosis drug has been linked to unusual thigh bone fractures in a small number of users, according to an alert issued by Health Canada.

Amgen Canada, the company that produces the drug denosumab under the brand name Prolia, joined with Health Canada in issuing a warning statement last week. Amgen said, however, that instances of the fractures were very rare.

Last year, a warning was issued by Health Canada about an entire class of osteoporosis drugs, known as bisphosphonates, which had been linked to unusual thigh bone fractures in users.

These unusual fractures, which are known as Atypical Femoral Fractures (AFF), can occur with little or no physical impact. They have often been associated with long-term use of certain osteoporosis medications. The fracture is often preceded by thigh or groin pain which may occur several weeks or months before the actual fracture.

“This is new safety information related to unusual thigh bone fractures and the use of Prolia,” Sabrina Paiva, senior manager for product communications at Amgen, told The Ward.

“Cases of AFF have been confirmed in patients receiving Prolia participating in the ongoing open-label extension study of the pivotal phase three fracture trial in postmenopausal osteoporosis,” said Paiva. “These events have occurred very rarely in less than one in every 10,000.”

Health Canada said the study is evaluating the long-term efficacy and safety of Prolia in 4,550 post-menopausal women.

The drug Prolia is used in the treatment of post-menopausal women with osteoporosis who have been found to be at high-risk for fracture. It works by reducing the amount of bone broken down by the body, making bones less likely to break.

Osteoporosis Canada, the national organization working for people who have or are at risk of osteoporosis, said in a statement released last week that while unusual fractures had been seen in people taking bisphosphonates and denosumab for several years, a causal relationship between the use of osteoporosis medications and these fractures had not yet been confirmed. The statement also said that the atypical fractures had been reported without osteoporosis therapy.

Tanya Long, education manager at Osteoporosis Canada, stressed although there has been some instances of these fractures associated with the use of denosumab, “they were very, very rare.”

Blossom Leung from Health Canada’s communications office said that all marketed health products have benefits and risks associated with their use.

“Health Canada continues to monitor the safety profile of health products once they are marketed to ensure that the benefits of the product continue to outweigh the risks,” said Leung in an e-mail to The Ward.

Leung said manufacturers  are also responsible for the continuous assessment of the benefits and risks of their health products.  “The risks of a health product should never be considered in isolation, but instead, the balance between possible risks and potential benefits needs to be taken into account, with benefits always outweighing the risks,” she said.

Leung added that information on adverse reactions, precautions, warnings and contra-indications associated with health products is provided in the product information to keep prescribers and patients informed.

Osteoporosis Canada recommends patients who are taking osteoporosis medications and experiencing symptoms like pain in the thigh or groin to contact their doctors immediately.

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