Experts are worried about information that suggests that patients have a greater risk of hospitalization due to heart problems and that they can die.
Federal Health Advisors affirm that the label carried by NGOLYZA and other diabetes medications should bring new information on possible risks of heart problems and death.
The Diabetes Expert Panel of the Food and Drug Administration (FDA) expressed concern about information that suggests that patients taking Onglyza and Kombiglize have a greater risk of hospitalization due to heart problems and that they can die.The panel voted 14-1 that this information should be included in the medication label.But experts added that other factors hinder the analysis of whether the risk is real or a statistical anomaly.
The panel voted 13-1, with an abstention, that the cardiac security profile of the medications is acceptable.
The FDA convened the meeting to analyze the information of a several -year study on the effects of NGOLYZA and KOMBIGLIZE on the heart.The agency began to demand these studies in 2008