Jim Shannon – 2015 Parliamentary Question to the Department of Health
The below Parliamentary question was asked by Jim Shannon on 2015-11-10.
To ask the Secretary of State for Health, if he will discuss with the Royal Colleges the potential side effects of osteoporosis drugs on (a) jaw and (b) general bone health.
George Freeman
As with all medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Government’s independent expert advisory body the Commission on Human Medicines (CHM) keep the safety of osteoporosis drugs under continual review including their effects on the jaw and on bone health. The MHRA, together with the CHM, ensures that the product information for osteoporosis medicines contains up to date information and issues updated advice as appropriate.
Warnings about the risks of osteonecrosis of the jaw (severe bone damage in the jaw) and atypical fractures of the femur (unusual fracture of the thigh bone) are included in the product information (Summary of Product Characteristics for healthcare professionals and Patient Information Leaflet for patients) for all medicines containing bisphosphonates or denosumab which are used in the treatment of osteoporosis. New information and advice on these risks have been communicated to healthcare professionals in the MHRAsafety bulletin in 2006, 2007, 2009, 2011, 2013 and 2014 as new information has become available. A patient reminder card on the risk of osteonecrosis of the jaw is currently being introduced for patients treated with denosumab and bisphosphonates given by injection and healthcare professionals have been informed of this new measure via the MHRA bulletin.
Information about the recognised risks of osteonecrosis of the jaw and atypical fractures of the femur with bisphosphonates and denosumab is also included in the 2014 ‘Osteoporosis – Clinical Guideline for prevention and treatment’ developed by the National Osteoporosis Guideline Group which includes the Royal College of Physicians.
