The U.S. Food and Drug Administration (FDA) has announced it is conducting an investigation into saxagliptin (marketed as Onglyza and Kombiglyze XR) specifically looking into a possible link between the diabetes drug and an increased risk of heart failure. In making its announcement, the FDA noted that the saxagliptin study is part of a larger evaluation of other type II diabetes medications.
On February 11, 2014, the FDA announced it has requested clinical trial data from the maker of saxagliptin, a type II diabetes drug, so the agency could study a possible link between the drug and heart failure. The announcement was made after a study published in the New England Journal of Medicine suggested an increased rate of hospitalization due to heart failure in patients who use saxagliptin when compared with patients who used an inactive treatment. The study, according to the FDA, did not find increased rates of death, heart attack or stroke.
Type II diabetes is a disease in which there is a high level of sugar, or glucose, in the blood because the body does not make or properly use the hormone insulin. If left untreated, type II diabetes can lead to serious problems. Saxagliptin is used along with diet and exercise to lower blood sugar in adults with type II diabetes. It works by increasing the amount of insulin produced by the body after meals, when blood sugar is high.
When it made its announcement, the FDA noted that it considers information from the New England Journal of Medicine study to be preliminary.
To conduct its investigation, the FDA has reportedly requested clinical data from the manufacturer’s trial.
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