The decision was made after the European Medicines Agency recommended the withdrawal from sale of medicinal products containing rosiglitazon, announced today a management ALMIS.
Was withdrawn from sale, as stated, film tablets, 4 mg and 8 mg of the drug Avandia, manufacturer Glaxo Wellcome Production, France, and Glaxo Wellcome SA Spain.
Licensee for the distribution of this drug in Serbia, the Belgrade office GlaxoSmithKline.
European Medicines Agency has recommended the withdrawal from sale of medicinal products containing rosiglitazon published after the evaluation of new data on adverse cardiovascular reactions and the relationship benefits and risks when applying this medicine.
Recommendations related to the drugs Avandia, Avandamet and Avaglim, of which only drug Avandia registered in Serbia 6th March 2006. year, but since since 2008. not in circulation, noted in a statement.
Rosiglitazon in the EU for the first time registered 2000th and even then were identified fluid retention and increased risk of heart failure as an important security issues in the application of this drug.
Therefore, the cardiovascular safety of patients who are taking rosiglitazon intensively monitored.
In order to reduce cardiovascular risk rosiglitazona application was limited to the treatment of choice for the treatment of diabetes and is contraindicated in patients with heart failure.
Additional information to which there was conducted on the basis of clinical studies, FARMAKOM-epidemiological study and meta-analysis, pointed to the possibility of an increased risk of ischemic heart disease when using rosiglitazona.
Therefore, in the past three years, conducted more restrictive measures (warnings and precautions) for the use of the drug in patients with ischemic heart disease, said in a statement ALMIS.
New EMA assessment of available data was undertaken in July 2010th and found that the results of recent studies speak in favor of the existence of an increased cardiovascular risk in patients treated rosiglitazonom, despite the previously implemented measures.
Commission for Human Medicines in EMA concluded that "the relationship benefits and risks when applying this medicine can no longer be considered positive, and so was yesterday officially announced the recommendation of the abolition of permits and the withdrawal of the drug from the market.
As the drug Avandia, for commercial reasons but withdrawn from the market, this measure will not affect the current therapeutic approach in the treatment of diabetic patients in Serbia, it was said from a ALMIS.
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