Reason for request
In view of its concerns related to the risk of onset of DRESS and venous thromboembolism, the Transparency Committee considers that the actual benefit of PROTELOS is moderate in a population restricted to :
Improvement in actual benefit
Like the bisphosphonates (alendronate, risedronate, zoledronate), PROTELOS has demonstrated its efficacy in preventing vertebral and nonvertebral fractures, including femoral neck fractures. However, the tolerance data show a risk of venous thromboembolism and a risk of serious hypersensitivity syndrome (DRESS), the onset of which is unpredictable. In view of these factors and in view of the alternative forms of treatment available, it seems inappropriate to maintain an improvement in actual benefit for this medicine. Consequently, the Transparency Committee considers that PROTELOS does not provide any improvement in actual benefit (V) to the treatment strategy for postmenopausal osteoporosis.