ALERTA CARDIACA SOBRE DROGA USADA PARA LA OSTEOPOROSIS

Europe's drug watchdog has moved to restrict the use of osteoporosis drug strontium ranelate (Protos), citing an increased risk of myocardial infarction compared with placebo. A European Medicines Agency committee said data on the drug "were of concern", and would be evaluated further in an expedited, in-depth review. In the meantime, the committee recommended avoiding strontium ranelate in people with current or previous ischaemic heart disease, peripheral arterial disease or cerebrovascular disease and those with inadequately controlled hypertension. The drug should be used only for treatment of severe osteoporosis, the EMA's Pharmacovigilance Risk Assessment Committee said. "The data from clinical studies showed that there was an increased risk of a heart attack in post-menopausal women taking [Protos] compared with those taking placebo, although there was no increase in deaths," the EMA said in a statement released Friday. "On the whole, the data were of concern given other serious risks (blood clots and rare serious skin reactions) that were identified in a previous EMA review in 2012." Some 350,000 strontium ranelate scripts were dispensed through the PBS in 2012 and there have been 60,000 in 2013 to date, figures show. The Australian product information lists current or previous VTE as a contraindication, but does not mention cardiovascular disease or hypertension. Final recommendations from the EMA's in-depth review will be made public following another meeting on 22-25 April and review by the European Commission. The current findings emerged as part of a routine risk-benefit assessment, which included data on 7,500 patients. Protos manufacturer Servier Australia said the company was aware of the recommendations and had provided all relevant information to the Therapeutic Goods Administration. "We will communicate any changes to the Protos Product Information to healthcare professionals," Servier said in a statement.

Published with Blogger-droid v2.0.3