FDA Warns of Heart Failure and Other Issues for Onglyza Users

Users of the Type 2 diabetes medication Onglyza claim the drug causes heart failure and the drug’s manufacturer knew of the risk and failed to warn consumers.

The most recent lawsuit, filed by Texas man Wrendell Chester against Bristol-Myers Squibb and AstraZeneca, claims his heart failure was caused by use of the drug. According to the lawsuit, Chester took Onglyza and Kombiglyze XR between 2010 and 2015. Following his use of the drugs, he suffered congestive heart failure and heart failure. He also experienced acute hypoxic respiratory failure, which occurs when the blood is oxygen deficient.

Chester’s lawsuit accuses the drug companies of manufacturing a defective product, failure to warn of risk, and negligence The claim includes accusations of conspiring to convey false and misleading information about the safety of the drugs and to conceal risks of serious health side effects.

Onglyza received approval from the FDA in 2009. Kombiglyze received it in the following year. The drugs are part of the DPP-4 inhibitors class and work by controlling blood sugar by way of supporting pancreatic production of insulin after eating. They also reduce the amount of glucose the liver produces.

Doctors and patients prefer these medications because they don’t trigger weight gain like many other Type 2 diabetes drugs on the market today.

It was likely for this reason that the drugs remained popular despite several medical studies linking them to serious side effects. The concern was significant enough that the FDA ordered AstraZeneca to add warning labels to both Onglyza and Kombiglyze XR. The FDA later released a safety communication in 2016 alerting the public to the increased risk for heart failure among Onglyza users, especially those with pre-existing heart or kidney issues.

The FDA also linked use of the drug to pancreatitis and the possible development of cancer cells in the pancreas and warned the public that use of the drug could lead to an increased risk for severe joint pain.

In addition to the serious side effects, Onglyza and Kombiglyze are also known to trigger a variety of mild to moderate side effects, including:

• Urinary tract infections
• Stomach pain
• Headache
• Diarrhea
• Upper respiratory tract infection
• Bloating
• Sore throat
• Nausea
• Runny nose
• Cough

It should be noted that the increased risk associated with Onglyza use might not be as high as the risk faced by users of other diabetes drugs, but the company was still responsible for warning consumers of any known or potential risks associated with the drug.

Pancreatitis Risk in Onglyza Users Severe

In addition to concerns about Onglyza users developing heart failure, there is also concern that the drug could cause pancreatitis.

Pancreatitis is an inflammation of the pancreas and triggers symptoms such as pain in the upper abdominal area, tender and swollen abdomen, indigestion, nausea, and vomiting.

All drugs in the DPP-4 class carry warnings related to pancreatitis. The label warns that users of the drugs should be carefully watched for pancreatitis symptoms after researchers confirmed acute pancreatitis in 0.2 percent of Onglyza users. Nearly all of Onglyza users have a pre-existing risk for pancreatitis and the drug increases that risk.

Onglyza and drugs like it are also linked to severe and disabling joint pain. It’s an uncommon side effect, but the risk was great enough that in 2015, the FDA required drug makers to add a warning label to alert doctors and consumers to the risk. Users are encouraged to continue their use of the drug if they experience severe and persistent pain, but to alert their doctors of their condition.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.