FDA Rejects Onglyza Hybrid Drug


In Oct. 2015, AstraZeneca, the manufacturer of Onglyza, announced that their new combo drug was not approved by the FDA. The FDA rejected the drug, which contains saxagliptin and dapagliflozin, stating that additional clinical studies were needed to provide information about its safety and side effects.

AstraZeneca came under fire last year when it was reported that Onglyza was linked to heart failure. In April 2015, the FDA assigned a panel to assess the SAVOR Outcomes Trial, a study conducted in 2013 that demonstrated the likeliness of heart failure.

The study looked at 16,492 diabetes patients who either had to be hospitalized because of heart failure or had a high risk of heart failure. The results of the study found that 27% of the patients who were hospitalized or identified for heart failure, strokes, and other cardiac issues had taken Onglyza for a continued period of time.

The Food and Drug Administration (FDA) concluded that Onglyza, or more specifically saxagliptin, creates a great risk of heart problems. This is because Onglyza is a member of a class of diabetes drugs called incretin mimetics that contains DDP-4 inhibitors. DDP-4 inhibitors substantially increase the risk of heart failure.  The new combo drug was intended to be a safer alternative to Onglyza.

The situation worsened after the 2015 World Diabetes Conference. During the conference, Dr. Holman and his colleagues presented results from their study, which indicated that Onglyza also posed the risk of developing ketoacidosis – a serious condition in which the body produces excess blood acids (ketones). Class action lawsuits are being filed against AstraZeneca as more patients exhibit unexpected negative side-effects after taking Onglyza.

The proposed new pill also contains SGLT2 inhibitors, which add to the risk of kidney problems and ketoacidosis. These health problems can cause patients with severe symptoms to go into a coma, or even die. AstraZeneca now claims that they will work alongside the FDA to create a more-effective, and less dangerous, drug for diabetes patients.

If you are suffering from heart failures, or any other unexpected health conditions, after taking Onglyza for an extended period of time, contact Morgan & Morgan for a free, no-obligation case review.