Diabetes Drug Kombiglyze XR Linked to Heart Failure

Saxagliptin, which is sold under the brand name Kombiglyze XR when blended with metformin, is a time-release type 2 diabetes drug shown to control blood sugar levels in adults. Though approved for sale and considered safe by some, the drug has been linked to heart failure.

Concerns about Kombiglyze XR were severe enough that the FDA ordered the manufacturers to add warnings to the drug’s label explaining the risk in April 2016. The order came after a clinical trial suggested that saxagliptin increased the risk of heart failure by nearly 30 percent.

Following the order, more than 200 lawsuits were filed against the manufacturers of Kombiglyze XR.

According to the claims, the manufacturers of the drug were aware of the risk but did not warn doctors or consumers. Claimants are seeking compensation for the cost of their medical care, lost wages, and pain and suffering.

Texas Man Files Lawsuit after Developing Heart Failure as a Result of Kombiglyze XR Use

In one recent lawsuit, a Texas man filed a claim after he suffered serious injuries related to heart failure after using Kombiglyze XR. The claim was filed against Bristol-Myers Squibb and AstraZeneca. He is seeking more than $75,000 in damages.

According to the claim, the man used saxagliptin for approximately three years up until February 2017. He eventually developed heart failure, which he claims caused pain and suffering, loss of earning capacity, and mental anguish. The claim also states he is still incurring medical costs.

According to the claim, the drug’s manufacturers hid its risks from doctors, causing them to not even bother exploring other treatment methods.

Manufacturers of Diabetes Drugs Face Multiple Lawsuits

Kombiglyze XR is not the only drug facing scrutiny. Manufacturers of Onglyza, a similar type 2 diabetes medication containing saxagliptin, are accused of hiding cardiovascular risks of that drug from doctors and patients, too.

In one complaint, plaintiff Wiley Williams, Jr. claims to have developed congestive heart failure after using Onglyza for less than a year. Williams claims the drug manufacturers “withheld, concealed, and downplayed information about the link between Onglyza and heart failure.”

Onglyza is similar to Kombiglyze XR, which is the extended release version of the medication. Kombilgyze XR combines saxagliptin with the older diabetes drug metformin, whereas Onglyza has a singular active ingredient (saxagliptin) and no metformin.

According to the lawsuit, those involved in the manufacture and sale of Onglyza acted in concert to conceal the dangers of the drug, which resulted in significant harm to those treated with saxagliptin-containing medications.

Williams’ case will be consolidated with other lawsuits already in the federal court system that were already combined as part of a federal multidistrict litigation (MDL).

Focus on the Testing and Safety of Diabetes Medications

According to officials, manufacturers have failed to properly test diabetes drug during development. They did not perform adequate clinical trials related to cardiovascular risks in at least one instance. 

The FDA has since ordered drug companies to investigate all of their diabetes drugs for cardiovascular risks. Diabetics have a higher risk for cardiovascular health issues and taking drugs that further increase that risk could prove catastrophic.

Common side effects for Kombiglyze XR are identified as:

• Nausea
• Vomiting
• Diarrhea
• Headache
• Respiratory infections
• Urinary tract infections
• Cold symptoms, including runny or stuffy nose, sneezing, and sore throat

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