As with all medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Government\u2019s 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.<\/p>
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.<\/p>
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 \u2018Osteoporosis - Clinical Guideline for prevention and treatment\u2019 developed by the National Osteoporosis Guideline Group which includes the Royal College of Physicians.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4020", "label" : {"_value" : "Biography information for George Freeman"} } , "answeringMemberConstituency" : {"_value" : "Mid Norfolk"} , "answeringMemberPrinted" : {"_value" : "George Freeman"} , "dateOfAnswer" : {"_value" : "2015-11-18", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2015-11-18T09:10:29.283Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health"} , "answeringDeptSortName" : {"_value" : "Health"} , "date" : {"_value" : "2015-11-10", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Osteoporosis: Drugs"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "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.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4131", "label" : {"_value" : "Biography information for Jim Shannon"} } , "tablingMemberConstituency" : {"_value" : "Strangford"} , "tablingMemberPrinted" : [{"_value" : "Jim Shannon"} ], "uin" : "15996"} , {"_about" : "http://data.parliament.uk/resources/100720", "AnsweringBody" : [{"_value" : "Department of Health"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/100720/answer", "answerText" : {"_value" : "
Information on National Health Service expenditure on drugs for the treatment of osteoporosis in primary and secondary care is in the table.<\/p>
<\/p>
<\/p>
<\/p>
Drugs for the treatment of osteoporosis have been defined as those included in the following British National Formulary sections:<\/p>
<\/p>
6.6 Drugs affecting bone metabolism<\/p>
<\/p>
9.5.1.1 Calcium supplements<\/p>
<\/p>
9.6 Vitamins (colecalciferol and ergocalciferol only)<\/p>
<\/p>
<\/strong><\/p> <\/p> Cost of drugs for the treatment of osteoporosis, England1<\/sup><\/p><\/td><\/tr> Drug Name2<\/sup><\/p><\/td> Primary Care<\/p> (£ million)<\/p><\/td> Secondary Care<\/p> (£ million)<\/p><\/td><\/tr> Year<\/p><\/td> 2009<\/p><\/td> 2010<\/p><\/td> 2011<\/p><\/td> 2012<\/p><\/td> 2013<\/p><\/td> 2009<\/p><\/td> 2010<\/p><\/td> 2011<\/p><\/td> 2012<\/p><\/td> 2013<\/p><\/td><\/tr> Alendronic Acid<\/p><\/td> 14.0<\/p><\/td> 12.4<\/p><\/td> 10.8<\/p><\/td> 9.7<\/p><\/td> 8.9<\/p><\/td> 0.8<\/p><\/td> 0.6<\/p><\/td> 0.5<\/p><\/td> 0.5<\/p><\/td> 0.4<\/p><\/td><\/tr> Alendronic Acid and Colecalciferol<\/p><\/td> 1.4<\/p><\/td> 1.2<\/p><\/td> 0.9<\/p><\/td> 0.7<\/p><\/td> 0.6<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td><\/tr> Calcitonin (Salmon)<\/p><\/td> 0.3<\/p><\/td> 0.3<\/p><\/td> 0.2<\/p><\/td> 0.2<\/p><\/td> 0.1<\/p><\/td> 0.0<\/p><\/td> 0.1<\/p><\/td> 0.1<\/p><\/td> 0.1<\/p><\/td> 0.1<\/p><\/td><\/tr> Calcium<\/p><\/td> 4.2<\/p><\/td> 4.7<\/p><\/td> 4.5<\/p><\/td> 3.7<\/p><\/td> 3.3<\/p><\/td> 0.9<\/p><\/td> 0.9<\/p><\/td> 0.9<\/p><\/td> 0.9<\/p><\/td> 0.9<\/p><\/td><\/tr> Calcium and Colecalciferol<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 2.2<\/p><\/td> 2.2<\/p><\/td> 2.1<\/p><\/td> 2.2<\/p><\/td> 2.3<\/p><\/td><\/tr> Clodronic Acid<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 2.9<\/p><\/td> 2.4<\/p><\/td> 1.6<\/p><\/td> 1.2<\/p><\/td> 0.9<\/p><\/td><\/tr> Colecalciferol<\/p><\/td> 42.4<\/p><\/td> 48.3<\/p><\/td> 58.5<\/p><\/td> 67.6<\/p><\/td> 75.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.4<\/p><\/td> 1.2<\/p><\/td><\/tr> Denosumab<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.2<\/p><\/td> 0.8<\/p><\/td> 1.9<\/p><\/td> 0.0<\/p><\/td> 0.1<\/p><\/td> 0.9<\/p><\/td> 2.3<\/p><\/td> 9.9<\/p><\/td><\/tr> Disodium Etidronate<\/p><\/td> 1.3<\/p><\/td> 1.0<\/p><\/td> 0.8<\/p><\/td> 0.6<\/p><\/td> 0.3<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td><\/tr> Ergocalciferol<\/p><\/td> 4.3<\/p><\/td> 7.8<\/p><\/td> 8.0<\/p><\/td> 7.0<\/p><\/td> 6.1<\/p><\/td> 0.1<\/p><\/td> 0.1<\/p><\/td> 0.1<\/p><\/td> 0.2<\/p><\/td> 0.3<\/p><\/td><\/tr> Ibandronic Acid<\/p><\/td> 12.1<\/p><\/td> 12.1<\/p><\/td> 11.4<\/p><\/td> 10.6<\/p><\/td> 4.7<\/p><\/td> 2.1<\/p><\/td> 2.0<\/p><\/td> 1.8<\/p><\/td> 1.5<\/p><\/td> 0.9<\/p><\/td><\/tr> Pamidronic Acid<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 9.6<\/p><\/td> 9.1<\/p><\/td> 9.4<\/p><\/td> 9.4<\/p><\/td> 8.7<\/p><\/td><\/tr> Risedronate Sodium and Risedronate Acid<\/p><\/td> 27.9<\/p><\/td> 22.9<\/p><\/td> 11.6<\/p><\/td> 2.4<\/p><\/td> 2.0<\/p><\/td> 0.8<\/p><\/td> 0.6<\/p><\/td> 0.3<\/p><\/td> 0.1<\/p><\/td> 0.1<\/p><\/td><\/tr> Sodium Clodronate<\/p><\/td> 7.8<\/p><\/td> 7.2<\/p><\/td> 6.3<\/p><\/td> 5.5<\/p><\/td> 4.3<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td><\/tr> Strontium Ranelate<\/p><\/td> 7.0<\/p><\/td> 7.8<\/p><\/td> 9.0<\/p><\/td> 9.2<\/p><\/td> 7.3<\/p><\/td> 0.6<\/p><\/td> 0.6<\/p><\/td> 0.6<\/p><\/td> 0.5<\/p><\/td> 0.2<\/p><\/td><\/tr> Teriparatide<\/p><\/td> 0.3<\/p><\/td> 0.4<\/p><\/td> 0.4<\/p><\/td> 0.5<\/p><\/td> 0.6<\/p><\/td> 2.7<\/p><\/td> 2.8<\/p><\/td> 2.7<\/p><\/td> 3.1<\/p><\/td> 3.2<\/p><\/td><\/tr> Zoledronic Acid<\/p><\/td> 0.1<\/p><\/td> 0.1<\/p><\/td> 0.1<\/p><\/td> 0.1<\/p><\/td> 0.1<\/p><\/td> 16.7<\/p><\/td> 18.0<\/p><\/td> 20.9<\/p><\/td> 23.7<\/p><\/td> 25.7<\/p><\/td><\/tr> Other Calcium Supplement Preps<\/p><\/td> 0.5<\/p><\/td> 0.6<\/p><\/td> 0.6<\/p><\/td> 0.5<\/p><\/td> 0.5<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td><\/tr> Other drugs3<\/sup><\/p><\/td> 0.2<\/p><\/td> 0.1<\/p><\/td> 0.1<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.2<\/p><\/td> 0.1<\/p><\/td> 0.1<\/p><\/td> 0.1<\/p><\/td> 0.0<\/p><\/td><\/tr> TOTAL<\/p><\/td> 123.8<\/p><\/td> 126.8<\/p><\/td> 123.4<\/p><\/td> 119.1<\/p><\/td> 115.4<\/p><\/td> 39.6<\/p><\/td> 39.6<\/p><\/td> 42.3<\/p><\/td> 46.2<\/p><\/td> 55.0<\/p><\/td><\/tr><\/tbody><\/table> <\/p> 1 <\/sup>Cost of drugs at NHS list price. It does not take account of discounts, dispensing costs, fees or prescription charges income. Totals may not add up due to rounding.<\/p> <\/p> 2<\/sup> The patent for some of these drugs may have expired during this period.<\/p> <\/p> 3<\/sup> \u201cOther drugs\u201d includes Calcium and Colecalciferol and Ergocalciferol, Calcium and Etidronic Acid, Calcium and Risedronic and Colecalciferol, Disodium Pamidronate, Ergocalciferol and Calcium, Etidronic Acid, Hydroxyapatite, Parathyroid Hormone, Salcatonin, Tiludronic Acid, other Bisphosphonate and other Preparations.<\/p> <\/p> <\/p> <\/p> Source: <\/em><\/p> <\/p> Prescription Cost Analysis (PCA) provided by the Health and Social Care Information Centre (primary care)<\/p> <\/p> Hospital Pharmacy Audit Index (HPAI) provided by IMS Health (secondary care)<\/p> <\/p> <\/p> <\/p> Since some drugs are prescribed to treat more than one condition and as the condition for which a drug is prescribed is not collected, it is not possible to separate the different conditions for which a drug may have been prescribed. The information provided may therefore include costs from the prescribing of these drugs for conditions other than for osteoporosis.<\/p> <\/p> <\/p> <\/p> <\/p> <\/p> <\/strong><\/p> <\/p> <\/strong><\/p> <\/p> <\/strong><\/p> <\/p>"}
, "answeringMember" : {"_about" : "http://data.parliament.uk/members/4020", "label" : {"_value" : "Biography information for George Freeman"}
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, "answeringMemberPrinted" : {"_value" : "George Freeman"}
, "dateOfAnswer" : {"_value" : "2014-10-30", "_datatype" : "dateTime"}
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, "answeringDeptShortName" : {"_value" : "Health"}
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, "date" : {"_value" : "2014-10-23", "_datatype" : "dateTime"}
, "hansardHeading" : {"_value" : "Osteoporosis: Drugs"}
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, "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"}
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], "questionText" : "To ask the Secretary of State for Health, how much has been spent on prescriptions for the treatment of osteoporosis in each of the last five years.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
, "tablingMember" : {"_about" : "http://data.parliament.uk/members/4026", "label" : {"_value" : "Biography information for Liz Kendall"}
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, "tablingMemberConstituency" : {"_value" : "Leicester West"}
, "tablingMemberPrinted" : [{"_value" : "Liz Kendall"}
], "uin" : "211731"}
, {"_about" : "http://data.parliament.uk/resources/100730", "AnsweringBody" : [{"_value" : "Department of Health"}
], "answer" : {"_about" : "http://data.parliament.uk/resources/100730/answer", "answerText" : {"_value" : " The following table shows estimated expenditure on research on asthma, motor neurone disease (MND) and osteoporosis by the Medical Research Council, other Research Councils and Innovate UK, and by the National Institute for Health (NIHR) through its research programmes, research centres and units, and research fellowships.<\/p> <\/p> <\/p> <\/p> £ million<\/em><\/p> <\/p> 2009-10<\/p><\/td> 2010-11<\/p><\/td> 2011-12<\/p><\/td> 2012-13<\/p><\/td> 2013-14<\/p><\/td><\/tr> Asthma<\/p><\/td><\/tr> Medical Research Council<\/p><\/td> Other Research Councils and Innovate UK<\/p><\/td> 0.0<\/p><\/td> 0.1<\/p><\/td> 0.3<\/p><\/td> 1.5<\/p><\/td> 0.8<\/p><\/td><\/tr> National Institute for Health Research<\/p><\/td> 2.6<\/p><\/td> 3.4<\/p><\/td> 2.4<\/p><\/td> 3.4<\/p><\/td> 3.8<\/p><\/td><\/tr> Total<\/p><\/td> Motor Neurone Research<\/p><\/td><\/tr> Medical Research Council<\/p><\/td> 7.0<\/p><\/td> 7.5<\/p><\/td> 4.2<\/p><\/td> 4.1<\/p><\/td> 3.6<\/p><\/td><\/tr> Other Research Councils and Innovate UK<\/p><\/td> 0.2<\/p><\/td> 0.2<\/p><\/td> 0.4<\/p><\/td> 0.7<\/p><\/td> 1.0<\/p><\/td><\/tr> National Institute for Health Research<\/p><\/td> 0.1<\/p><\/td> 0.1<\/p><\/td> 0.4<\/p><\/td> 0.7<\/p><\/td> 0.5<\/p><\/td><\/tr> Total<\/p><\/td> 7.3<\/p><\/td> 7.8<\/p><\/td> 5.0<\/p><\/td> 5.5<\/p><\/td> 5.1<\/p><\/td><\/tr> Osteoporosis<\/p><\/td><\/tr> Medical Research Council<\/p><\/td> 6.2<\/p><\/td> 5.4<\/p><\/td> 5.1<\/p><\/td> 4.6<\/p><\/td> 5.9<\/p><\/td><\/tr> Other Research Councils and Innovate UK<\/p><\/td> 0.0<\/p><\/td> 0.0<\/p><\/td> 0.1<\/p><\/td> 0.4<\/p><\/td> 1.0<\/p><\/td><\/tr> National Institute for Health Research<\/p><\/td> 0.3<\/p><\/td> 0.7<\/p><\/td> 0.8<\/p><\/td> 1.3<\/p><\/td> 1.8<\/p><\/td><\/tr> Total<\/p><\/td> 6.5<\/p><\/td> 6.1<\/p><\/td> 6.0<\/p><\/td> 6.3<\/p><\/td> 8.7<\/p><\/td><\/tr><\/tbody><\/table> <\/p> <\/p> <\/p> The figures shown for asthma exclude research into air pollution and potential effects on health outcomes including asthma.<\/p> <\/p> <\/p> <\/p> Total spend by the NIHR on asthma, MND and osteoporosis is higher than the figures shown because expenditure by the NIHR Clinical Research Network (CRN) on these diseases cannot be disaggregated from total CRN expenditure. NIHR expenditure relating to development of new drugs for asthma, MND and osteroporosis occurs primarily through NIHR research infrastructure including the CRN and cannot be disaggregated from total expenditure.<\/p> <\/p> <\/p> <\/p> Information on MRC expenditure into the development of new drugs for asthma, MND or osteoporosis is not available.<\/p> <\/p>"}
, "answeringMember" : {"_about" : "http://data.parliament.uk/members/4020", "label" : {"_value" : "Biography information for George Freeman"}
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, "answeringMemberConstituency" : {"_value" : "Mid Norfolk"}
, "answeringMemberPrinted" : {"_value" : "George Freeman"}
, "dateOfAnswer" : {"_value" : "2014-10-29", "_datatype" : "dateTime"}
, "isMinisterialCorrection" : {"_value" : "true", "_datatype" : "boolean"}
, "previousAnswerVersion" : {"_about" : "http://data.parliament.uk/resources/100730/answer/previousversion/25123", "answeringMember" : {"_about" : "http://data.parliament.uk/members/4020", "label" : {"_value" : "Biography information for George Freeman"}
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, "answeringMemberConstituency" : {"_value" : "Mid Norfolk"}
, "answeringMemberPrinted" : {"_value" : "George Freeman"}
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, "questionFirstAnswered" : [{"_value" : "2014-10-29T17:12:28.3318918Z", "_datatype" : "dateTime"}
], "questionFirstMinisteriallyCorrected" : [{"_value" : "2014-11-13T10:22:56.0372213Z", "_datatype" : "dateTime"}
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, "answeringDeptShortName" : {"_value" : "Health"}
, "answeringDeptSortName" : {"_value" : "Health"}
, "date" : {"_value" : "2014-10-23", "_datatype" : "dateTime"}
, "hansardHeading" : {"_value" : "Osteoporosis: Drugs"}
, "houseId" : {"_value" : "1"}
, "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"}
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], "questionText" : "To ask the Secretary of State for Health, how much from the public purse has been spent on the development of new drugs to treat symptoms of osteoporosis in each of the last five years.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
, "tablingMember" : {"_about" : "http://data.parliament.uk/members/4026", "label" : {"_value" : "Biography information for Liz Kendall"}
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, "tablingMemberConstituency" : {"_value" : "Leicester West"}
, "tablingMemberPrinted" : [{"_value" : "Liz Kendall"}
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<\/td> 22.2 <\/del>6.6<\/ins><\/p><\/td>17.5 <\/del>5.3<\/ins><\/p><\/td>17.2<\/del> 4.5<\/ins><\/p><\/td>19.4<\/del> 3.6<\/ins><\/p><\/td>18.8<\/del> 5.4<\/ins><\/p><\/td><\/tr>24.8<\/del> 9.2<\/ins><\/p><\/td>21.0<\/del> 8.8<\/ins><\/p><\/td>19.9<\/del> 7.2<\/ins><\/p><\/td>24.3 <\/del>8.5<\/ins><\/p><\/td>23.4<\/del> 10.0<\/ins><\/p><\/td><\/tr>