Закономерно дело закончилось добавлением предупреждения в инструкции относительно кетоацидоза и жизнеугрожающих мочевых инфекций, а также рекомендациям производителям отследить эффекты препаратов в длительных постмаркетинговых исследованиях.
Цитата:
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The US Food and Drug Administration (FDA) has updated the labels for sodium-glucose cotransporter 2 (SGLT2) inhibitors to include the risks for ketoacidosis and serious urinary tract infections. Both conditions can require hospitalization.
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Цитата:
We also identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors reported to FAERS from March 2013 through October 2014. All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.
As a result, we have added new Warnings and Precautions to the labels of all SGLT2 inhibitors to describe these two safety issues, and to provide prescribing and monitoring recommendations. We are also requiring manufacturers of SGLT2 inhibitors to conduct a required postmarketing study. This required enhanced pharmacovigilance study requests that manufacturers perform analyses of spontaneous postmarketing reports of ketoacidosis in patients treated with SGLT2 inhibitors, including specialized follow-up to collect additional information, for a period of 5 years.
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