Onglyza (saxagliptin) is a drug used by people with type 2 diabetes to help regulate their blood sugar levels. Kombiglyze XR is saxagliptin combined with metformin. These drugs may also cause cardiac failure that can lead to death. This is why lawsuits are being filed against Bristol-Myers Squibb and AstraZeneca around the country. These appear to be strong cases for plaintiffs so there is a real possibility that there will be a global settlement of these claims. This is particularly true because there are still a relatively small number of victims compared to most mass torts.
Onglyza works by inhibiting the proteolytic activity of DPP4. This increase the action of Glucagon-like peptide-l (GLP-I) which is an antihyperglycemic hormone known as an incretin. This causes glucose-dependent stimulation of insulin secretion while suppressing glucagon secretion, which may patients on Onglyza users lower their HAle.
DPP-4 (dipeptidyl peptidase-4) inhibitors are used in combination with other drugs to normalize blood sugar by causing the pancreas to produce more insulin after meals. This insulin boost blocks the liver from producing excessive blood sugar. Onglyza is a very popular medication for people with type 2 diabetes because unlike other blood sugar drugs Onglyza does cause weight gain.Onglyza Increases Risk of Heart Failure
Onglyza is manufactured and sold by Bristol-Myers Squibb ("BMS") and AstraZeneca Pharmaceuticals ("AZ"). Onglyza was first released on the market in 2009. A year prior to its release, the FDA issued new testing guidance to companies developing diabetes drugs such as Onglyza. The new guidelines called for testing to evaluate the cardiovascular safety of drugs like Onglyza. One of the primary health dangers of type 2 diabetes is an increased risk of heart problems. So the FDA wanted to make sure that drugs used to treat diabetes did not actually increase this even further.
BMS and AZ did not want to delay the release of their new drug. They ignored the new FDA guidance. Instead, they opted to perform cardiovascular safety testing after Onglyza was released. So the companies did not perform studies to determine if these drugs and its drastic alterations of the natural incretin hormone cycle, increased the risks of cardiac injury. It is particularly true in this case because patients taking these drugs are already at an increased cardiovascular risk. But studies take time and time delays profits.
Onglyza had been on the market for several years by the time BMS and AZ finally completed the recommended cardiovascular safety testing. The results of this safety testing showed that Onglyza created a significantly increased risk of heart failure.
These findings were published in 2013 in the New England Journal of Medicine. This prompted the FDA to issue a safety communication in February 2014 on a possible link between Onglyza and heart failure. Based on the results of this testing, an FDA advisory committee voted 13 to 1 in favor of adding heart failure warnings to Onglyza. The 1 member who voted against believed that the drug was so unsafe that it should be recalled. BMS and AZ ignored the FDA advice and continued to market Onglyza without adding any warning about heart failure risks. In April 2016 the FDA published its own official warning about the risk of heart failure associated with Onglyza.Onglyza Lawsuits
Over the last year, a number of Onglyza lawsuits have been filed against BMS and AZ. More that 200 Kombiglyze XR andOnglyza lawsuits pending are pending in federal court. Even more Onglyza lawsuits are on file against BMS and AZ in state courts. There have been more filed in recent months but we do not have the exact data on the total number of plaintiffs.
The Onglyza lawsuits allege that BMS and AZ had knowledge that there was an increased risk of heart failure associated with Onglyza. The suits allege that despite this knowledge BMS and AZ marketed and sold Onglyza without any warnings about the dangers or risk of heart failure. As a result, plaintiffs are claiming that their prescribing doctors were unaware of the health risks associated with Onglyza and that they were injured as a result.
To date, none of the Onglyza lawsuits have been settled or otherwise resolved. Our lawyers believe these Onglyza lawsuits are going to be very difficult to defend because of some of the decisions that the drug companies made. First, there is no dispute that BMS and AZ ignored the FDA guidance and put Onglyza on the market without the recommended testing on cardiovascular safety. Instead, they opted to this testing after the drug was on the market, only to learn that Onglyza did, in fact, increase the risk of heart failure. This looks really bad for them and could heavily influence a jury at trial. It makes it seem like BMS and AZ rushed the drug onto the market for financial reasons without regard for public safety.
BMS and AZ will also have a very difficult time defending their refusal to add warnings about heart failure risks. By 2013, plaintiffs' lawyers contend it was apparent that Onglyza may increase a patient's risk of heart failure. At that point, BMS and AZ should have added warnings about heart failure risks to the Onglyza label. Instead, they continued to market and sell the drug for several more years before adding a warning about heart failure. Again this decision just looks really bad and may suggest to a jury that BMS and AZ cared more about their bottom line than the lives of people who used their drug.
If you or someone you know has been taking Onglyza and believe you may have been injured as a result call Miller & Zois at 800-553-8082 or click here for a free online consultation.