AMGEN DISTRIBUTES IMPORTANT SAFETY UPDATES ON PROLIA®
- FLASCO
- June 1, 2015
- Drugs
AMGEN DISTRIBUTES IMPORTANT SAFETY UPDATES ON PROLIA®
The FDA has required Amgen to distribute a safety update on Prolia® (denosumab) to professional societies as part of its REMS (Risk Evaluation and Mitigation Strategy) program. Prolia® is a RANK ligand (RANKL) inhibitor used to treat osteoporosis in postmenopausal women who have high risk of bone fracture.
In a letter to ASCO and other professional societies, Amgen requested that they inform their members about the following serious risks of Prolia®:
Hypocalcemia
Osteonecrosis of the jaw
Atypical femoral fractures
Serious infections
Dermatologic reactions
Amgen has created a non-promotional patient counseling toolkit to assist physicians in discussing these risks with their patients. These materials are available at: www.proliahcp.com/risk-evaluation-mitigation-strategy or can be ordered through 1-800-77-AMGEN (1-800-772-6436).
