Onglyza (saxagliptin) is a drug used by people with type 2 diabetes to help regulate their blood sugar levels. Onglyza belongs to a relatively new class of drugs known as DPP-4 (dipeptidyl peptidase-4) inhibitors. Onglyza is 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 the cardiovascular safety testing after Onglyza was released. 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. As of November 2017 there were 44 Onglyza lawsuits pending in Federal District Courts in 24 states. Even more Onglyza lawsuits are on file against BMS and AZ in state courts.
The Onglyza lawsuits allege that BMS and AZ had knowledge that there was a serious 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.
- Get the most recent 2018 update in the Onglyza litigation
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.