This popular drug has raised flags for many in the FDA after disturbing numbers have come forward about the incidence of mortality from those using these drugs. Heart failure is becoming more common in patients who have taken this drug.
Onglyza is a drug class known as DDP-4 inhibitors. This class of drug is used to treat type 2 diabetes.
Type 2 Diabetes
Type 2 diabetes has become a significant problem throughout the United States. It is estimated that around 29 million people suffer from type 2 diabetes with around 8 million people that are unaware they have the condition. The overall cost for treating diabetes in the United States in 2012 came out to around $245 billion. This is a staggering number that has not showed any signs of decreasing.
Type 2 diabetes is a condition in which blood sugar levels in the body are higher than normal which causes insulin in the body to act improperly. As the pancreas works hard to produce enough insulin to lower blood sugar levels, it eventually becomes incapable of producing more which makes it impossible for the body to regulate blood sugar levels.
A study found a 27% increase in hospitalization for patients taking Onglyza versus a placebo.
Type 2 diabetes is often the cause of poor diet, physical inactivity, obesity, and family history. Type 2 diabetes can sometimes be reversed through lifestyle changes such as an improved diet or an increase in exercise. However, this is not always the case and sometimes medications may be needed to help battle the disease. One of the most popular drug types used to treat is known as DDP-4 Inhibitors.
These drugs first received FDA approval in 2006. They work by reducing glucose levels that the pancreas would typically be responsible for. They are considered a blockbuster class of drug because of their immense popularity as a treatment of type 2 diabetes.
The FDA Study
The FDA looked at around 16,000 people that had type 2 diabetes. It divided the subjects into two groups, with one taking a placebo and the other taking Onglyza. The study found a 27% increase in hospitalization for those taking Onglyza. The FDA concluded after this study that it was necessary to take a closer look at DDP-4 inhibitors and their potential to induce heart failure and death.
AstraZeneca, the manufacturer of Onglyza, is concerned about these FDA findings. They worry about the potential for an increased label warning. Their stock share fell 2% following the announcement by the FDA.
The FDA plans to hold a separate meeting in which it will discuss the best course of action to take in regards to Onglyza. Another major DDP-4 inhibitor is also under fire. The drug, Januvia, is currently undergoing a study being conducted by its manufacturer, Merck. They are investigating the potential heart risks that could be present. They plan on releasing their findings at this year’s American Diabetes Association meeting. If both of these drugs are found to cause significant harm, it could spell for a much different future for the incredibly popular DDP-4 inhibitors. The FDA’s decisions will be announced later this week.
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