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FDA will Investigate Potential Link Between Type 2 Diabetes Drug and Heart Failure

Filed February 13th, 2014 Laurie

The U.S. Food and Drug Administration (FDA) will investigate a potential link between the diabetes drug saxagliptin (marketed under the brand names Onglyza and Kombiglyze XR) and an increased risk of heart failure among users.

According to an agency Drug Safety Communication, the investigation was prompted by a study published in the New England Journal of Medicine which reported that patients taking saxagliptin had higher rates of hospitalization for heart failure compared to patients taking placebo.

The study, carried out by researchers from Brigham and Women’s Hospital and Harvard Medical School, produced surprising results, according to Dr. Eugene Braunwald. “Our data also show an increase in hospitalization for heart failure in patients who received saxagliptin, which was not expected and deserves further study,” he said in a press release obtained by U.S. News & World Report’s HealthDay blog.

The study involved more than 16,500 patients with type 2 diabetes from 26 countries, and was funded by the drug’s manufacturers, Bristol Myers Squibb and Astra Zeneca. The drug makers have until early next month to submit trial data to the FDA, after which the agency promises to “conduct a thorough analysis and report our findings publicly,” HealthDay reported.

Last fall, Bristol Myers Squibb reported that Onglyza did not improve hospitalization rates for diabetics with heart failure. In fact, the SAVOR clinical trial showed that rates of hospitalization for heart failure rose among diabetics taking Onglyza versus a placebo drug. Patients taking Onglyza in the clinical trial also experienced more hypoglycemic events than with the many other drugs used to treat type 2 diabetes.

Onglyza was also linked to an increased risk of pancreatic cancer in diabetic patients, along with other incretin mimetic drugs like Byetta, Victoza, and Januvia. Incretin mimetic drugs can cause pancreatitis, a painful and potentially deadly condition which is often a precursor to cancer. They can also cause kidney failure.

While the FDA awaits the trial data on saxagliptin, the agency recommends that patients do not stop taking their medication, but they should discuss any questions or concerns they have with their primary care physician.

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