What’s Going on with the Diabetes Drug Onglyza?

With the rise of Type 2 diabetes in the United States, drug makers have attempted to meet the demand for treatments to lower blood sugar levels in patients. A variety of drugs such as saxagliptin, alogliptin, linagliptin, sitagliptin, exenatide and liraglutide were developed to help patients treat their Type 2 diabetes. Several of these drugs have resulted in unexpected problems. One specific drug in particular is saxagliptin, which goes by the trade name “Onglyza.”

What Is Onglyza?

Onglyza was co-developed by Bristol-Meyers Squibb and AstraZeneca and is a DPP-4 inhibitor. It works by increasing the levels of incretin (a type of hormone) in the body. Incretins lower blood glucose levels by reducing the amount of sugar the liver makes and increasing the amount of insulin released by the pancreas.

In conjunction with diet and exercise, Onglyza is supposed to help adults with Type 2 diabetes control their blood sugar levels and avoid long-term health issues, such as nerve damage, blindness, kidney damage and heart problems. Ironically, it ended up increasing the risk of suffering from some of these ailments.

Are There Health Problems?

In a small number of drug users, there is an increased risk of headache, upper respiratory tract infection, urinary tract infection, severe joint pain and hypoglycemia (low blood sugar).

More serious problems include an increased risk of heart failure and a potential link to pancreatitis and pancreatic cancer. A 2013 study found a 27% increased risk of hospitalization due to heart failure. As a result of this data, the US Food and Drug Administration’s (FDA) set up a special panel to review Onglyza. Out of the 15 panel members who voted, 14 of them voted to update the drug’s warning label to reflect this heart failure risk. The lone holdout? That panelist voted to remove Onglyza from the US market entirely.

There were also studies involving DPP-4 inhibitors that found an increased risk of pancreatitis (inflammation of the pancreas) and pancreatic cancer. To be fair, the connection between the DPP-4 inhibitor family of drugs and pancreatitis and pancreatic cancer is not conclusive. However, precancerous cells and benign tumors (called adenomas) have been found in the pancreases of patients who had been taking DPP-4 inhibitors.

Are There Any Lawsuits Involving Onglyza?

Currently, there are a few lawsuits in the court system, but this number will increase. Most industry watchers expect an increase because of post-release studies involving Onglyza.

During clinical testing, Onglyza met the FDA cardiovascular safety requirements, but barely. So the FDA wasn’t fully convinced that the drug was safe for the heart and ordered the drug makers to conduct additional testing once Onglyza was approved for sale to the general public.

A test of over 16,000 individuals over approximately two years revealed the 27% increased risk of hospitalization due to heart failure. This means that there are a lot of patients who took Onglyza before updated heart failure warnings were ordered by the FDA.

Additionally, there is much more extensive litigation of other, related drugs. Drugs with brand names such as Victoza, Januvia, Byetta and Janumet are already in multi-district litigation, or MDL. Given the similarities between these drugs and Onglyza with respect to how they work and problems associated with taking them, it’s probable that the makers of Onglyza will see themselves in a comparable legal fight.

The Future of Onglyza

Determining whether Onglza and its makers face large scale litigation is impossible to predict with certainty, but it is anticipated. If there are any significant developments, I’ll be sure to provide an update.