MHRA Drug Safety Update: Denosumab 60 mg (Prolia) and rare cases of atypical femoral fracture with long-term use

Source: MHRA Area: Evidence > Medication Safety The February Drug Safety Update from the MHRA includes information on the development of atypical femoral fractures that have been reported rarely in patients with postmenopausal osteoporosis receiving long-term (?2.5 years) treatment with denosumab 60 mg (Prolia) in a clinical trial.   The following advice has been issued to healthcare professionals:   . During denosumab treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Patients presenting with such symptoms should be evaluated for an incomplete femoral fracture.   . Atypical femoral fractures may occur with little or no trauma in the subtrochanteric and diaphyseal regions of the femur.   . The contralateral femur should be examined in denosumab-treated patients who have sustained a femoral shaft fracture, as atypical femoral fractures are often bilateral   . Discontinuation of denosumab treatment should be ...
Source: NeLM - Patient Safety - Category: Drugs & Pharmacology Source Type: news