J Paediatr Child Health 38:497–500PubMedCrossRef 34. Konstantynowicz J, Bialokoz-Kalinowska I, Motkowski AZD8186 manufacturer R et al (2005) The characteristics of fractures in Polish adolescents aged 16–20 years. Osteoporos Int 16:1397–403PubMedCrossRef 35. Buttazzoni C, Rosengren EB, Tveit M et al (2013) Does a childhood fracture predict low bone mass in young adulthood? A 27-year prospective controlled study. J Bone Miner Res 28:351–59PubMedCrossRef 36. Cheng S, Xu L, Nicholson PH et al (2009) Low volumetric BMD is linked to upper-limb
fracture in pubertal girls and persists into adulthood: a seven-year cohort study. Bone 45:480–486PubMedCrossRef 37. Kawalilak CE, Baxter-Jones AD, Faulkner RA et al (2010) Does childhood and adolescence fracture influence bone mineral content in young adulthood? Appl Physiol Nutr Metab 35:235–43PubMedCrossRef”
“The balance between the benefits and the risks of any medical treatment, action for prevention, or diagnostic procedure lies at the heart of any clinical decision. In line with this, the European GANT61 solubility dmso Medicines Agency (EMA) recently set up a series of Good Pharmacovigilance Practices to reinforce procedures for surveillance and reporting of adverse events with authorised
medical products [1]. These new regulations are currently being applied throughout all EU member states. In this context, MycoClean Mycoplasma Removal Kit the GM6001 molecular weight safety of all centrally registered drugs is closely monitored by the EMA through a new committee, the Pharmacovigilance Risk Assessment Committee (PRAC), which was launched in October 2012. The procedures include regular submission of periodic safety update reports (PSURs). Naturally, treatments in osteoporosis are no exception to these regulations. In November 2012, the PSUR for strontium ranelate, which encompassed a number of new randomised clinical trials, included an updated assessment of the overall safety of the treatment and was submitted to the
PRAC in accordance with the regulatory schedule. The overall safety analyses showed an increased cardiovascular risk in patients treated with strontium ranelate [2]. This ongoing process has led to a label change, and, in order to mitigate the cardiovascular risk, strontium ranelate is now contraindicated in patients with a history of cardiovascular disease, i.e. in patients with a history of ischaemic heart disease, peripheral artery disease, and/or cerebrovascular disease and in those with uncontrolled hypertension. As a precaution, patients should now be evaluated for cardiovascular risk before starting treatment with strontium ranelate and at regular intervals during treatment. In the light of these procedures, the results of two new studies that recently became available are published together in this issue of Osteoporosis International [3, 4].
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