While Prolia Is An Alternative To Bisphosphonates Such As Fosamax, It Has Similar Increased Risk Of Low-Stress Femur Fractures Side Effect
SUMMARY: Prolia (denosumab) is an alternative approach to the treatment of osteoporosis that was approved by the FDA in 2010. Like bisphosphonates, Prolia is an antiresorptive drug. As such, it is not surprising that we are starting to hear about cases of stress fractures or low-stress fractures of the femur in patients using Prolia. And given the short time it has been on the market, we fully expect the number of femur fracture cases associated with Prolia to increase.
Relevant to the three case reports are these so-called “Dear Doctor” letters sent in late 2012 by the drug company that sells Prolia in the US and Canada to healthcare providers warning them about the risk of atypical or unusual thigh bone / femur fractures is patients using Prolia:
- 9/12/12 Amgen “Dear Doctor” Letter in US: Serious risks associated with the use of Prolia
- 11/21/12 Amgen Canada Inc. “Dear Doctor” Letter in Canada: Prolia® (denosumab) – Risk of Unusual Thigh Bone Fractures
We will continue to monitor this emerging drug safety issue that will likely affect more patients as the number of Prolia prescriptions increases in the coming years.
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