AstraZeneca proposed a new drug to treat type-2 diabetes: a combo drug containing two of the company’s existing drugs, saxagliptin (Onglyza) and dapagliflozin (Farxiga).

The FDA, however, is requiring more clinical trial data before the agency will approve it. This FDA denial and request for more testing is AstraZeneca’s second recent setback, with the other issue involving a postponement of clinical trials on a proposed combined cancer drug.

It is unclear whether the data on the treatment’s formulation was lacking or if safety concerns were holding back the approval for the proposed Onglyza combination drug.

The delay will likely be a year or two. A spokesperson for AstraZeneca said the company can’t yet say when it will be able to reapply for FDA approval.

Onglyza Side Effects

Onglyza is an oral diabetes medication approved by the FDA in 2009. It is considered a DPP-4 inhibitor and it works by altering the action of incretins, which are hormones in the body.

The drug allows the pancreas to release more insulin, and inhibits glucagon, a glucose-raising substance. The increase in insulin and decrease of glucagon combines to lower blood glucose levels.

While Onglyza has been very effective for some individuals who have been unable to be helped by other drugs, some patients taking Onglyza have reported experiencing severe side effects and complications.

Onglyza has been linked to pancreatitis, pancreatic cancer, heart failure and thyroid cancer. These conditions are quite distinct from one another, making it clear that the way Onglyza affects the body can be much more systemic than just affecting the pancreas alone.

Issues involving the pancreas were the least surprising complications experienced by individuals using the drug. Because the pancreatic cells are stimulated to make insulin, the pancreas can become inflamed, causing pancreatitis. Pancreatitis can be serious and sometimes fatal.

Pancreatic cancer cells reportedly can develop with pancreatic stimulation by the drug. Pancreatic cancer is usually caught only in later stages and has a poor prognosis with 95% of individuals not living beyond 5 years of their diagnosis.

Heart Failure

Heart failure is when the heart cannot pump enough blood to meet the demands of the body. The heart becomes weakened from working so hard and becomes less efficient.

In a common type of heart failure called congestive heart failure, fluid begins to build up in the extremities and organs, causing the body to become congested. In this type of heart failure, the kidneys become affected by the weak heart and cause the body to retain fluid.

Earlier this year, the FDA met to talk about safety concerns of Onglyza. Despite the increased risk of heart failure and increased risk of hospitalization due to heart failure, the agency decided to update the safety label rather than remove the drug from the market.

The FDA has issued safety warnings about other incretin drugs similar to Onglyza. Victoza is one such drug, which caused malignant thyroid tumors in rats. Byetta is another drug that has been linked to thyroid cancer.

It has been assumed that since Onglyza is chemically similar to these other drugs, Onglyza itself may cause individuals to have an increased risk of developing thyroid cancer.

Onglyza Lawsuit Information

If you or a loved one has been diagnosed with pancreatitis, pancreatic cancer, heart failure or thyroid cancer following the use of Onglyza, you may be entitled to legal compensation. An experienced Onglyza lawyer can review your case at no charge to you and can help you understand your legal options.