The FDA said on Tuesday that it was adding new warning to the labels of diabetes drugs containing the saxagliptin and alogliptin. The FDA said the drugs “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.” The announcement comes two years after an FDA panel recommended that…
FDA Adds Heart Failure Warning To Saxagliptin and Alogliptin Labels
April 6, 2016 by Leave a Comment
FDA Investigating Heart Failure Risk Linked To Onglyza
February 11, 2014 by Leave a Comment
The FDA said today that it was conducting an investigation of a possible increased risk for heart failure associated with the diabetes drug saxagliptin. Saxagliptin is marketed by AstraZeneca as Onglyza and Kombiglyze XR. (AstraZeneca recently completed the purchase of all rights to the drug from its manufacturer, BristolMyers-Squibb.) The investigation stems from findings from the cardiovascular outcomes trial SAVOR-TIMI 53 trial in which more…
Top Line Results: No Cardiovascular Benefits Found For Saxagliptin
June 19, 2013 by Leave a Comment
Top line results of a large phase 4 study with saxagliptin (Onglyza, Bristol-Myers Squibb and AstraZeneca) demonstrate that the drug is safe but has no cardiovascular benefits. AstraZeneca and Bristol-Myers Squibb today announced the top line results for the SAVOR-TIMI-53 Cardiovascular Outcomes Trial of Onglyza®. The full results are scheduled to presented at the annual meeting of the European Society of Cardiology in Amsterdam on…
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