Onglyza and Kombiglyze are two of the many drugs intended for use in Type 2 diabetes patients. They are also known by their trade names saxagliptin and metformin, respectively. At one time, both were considered to be promising front-line options in the fight against the diabetes epidemic, and though they do provide some symptom resolution, research is also uncovering some problematic risks with these medications. And the research is only beginning, along with legal action against the drugs’ manufacturers – Bristol-Myers Squibb and AstraZeneca.
The Many Dangers of New Diabetic Drugs
Saxagliptin hit the market in 2007 and metformin in 1995, though they had been known for a while before that. In pharmaceutical terms, that makes metformin and saxagliptin young, and they aren’t the first promising, new diabetic drugs to eventually find their way into the crosshairs. Several drugs that behave like saxagliptin have been developed and marketed under other names, and also produced worrying effects.
According to Bristol-Myers Squibb and AstraZeneca, and later confirmed by several scientific papers, saxagliptin and metformin are effective at reducing the concentration of glucose in the blood. It’s not completely understood how Onglyza and Kombiglyze produce their effects, but it is known that they inhibit the production of glucose by the liver. In a patient with Type 2 diabetes, the rate of glucose production in the liver is three times that of a healthy person. By taking saxagliptin and metformin, this rate of glucose production can be cut by a third.
Those are significant benefits, but at what cost? Of the two, saxagliptin is generating more attention, specifically due to an April 2016 FDA statement calling for additional warnings on the drug’s packaging. This warning regarded heart failure, as it is one of the most serious and more common complications due to saxagliptin use. This came after a review of approximately 16,500 patients using the medication. Of these, more than 1,200 reported a major cardiovascular event. This may have included heart attack, stroke, or a deep thrombotic event, all of which can be fatal. Currently, Onglyza and Kombiglyze are considered serious threats to heart health, and during the FDA review, 14 of 15 reviewers agreed to add additional warnings. The 15th reviewer recommended withdrawing saxagliptin from the U.S. market completely.
Although yet to be confirmed, medications like saxagliptin and metformin are also believed to potentially harm the pancreas. A 2013 study regarding some diabetic inhibitors found that when the medication was administered to rats, it caused several changes to the pancreas, some of which could directly lead to pancreatic cancer. A review by the FDA and European Medicines Agency (EMA) have not found the same link in humans, but representatives from the FDA acknowledge that further research will be needed to disprove the link.
And that research may not come soon enough. Some victims of these dangerous drugs are already taking legal action against Bristol-Myers Squibb and AstraZeneca. A multi-district lawsuit involving 53 cases was filed on August 26, 2013, concerning four branded diabetes drugs. Saxagliptin and metformin are among the drugs involved in the claim. The litigation was pushed forward because the 53 cases involved highly similar case histories, including an onset of pancreatic cancer. Such cases may set a precedent for Onglyza and Kombiglyze lawsuits.
Another worrisome case involves a Chicago woman who died in October 2013, after three years of taking saxagliptin. According to the woman’s daughter, who filed the lawsuit on her behalf, the victim suffered a heart attack just one year after being prescribed the drug and had to be hospitalized. In 2013, the victim had to be hospitalized twice more for heart complications before dying from heart failure.
Clearly, people have reason to be skeptical of Onglyza and Kombiglyze. Personal injury attorneys are also concerned about the safety research surrounding both drugs, and can use the latest scientific findings to help build a case for a victim. By the time patients realize their diabetes drugs are causing their heart or pancreas problems, it might be too late. The drug manufacturers who rush products to market and ignore and/or suppress critical research findings should be held accountable for the injuries they cause and the lives they disrupt.
Terry Bryant is Board Certified in personal injury trial law, which means his extensive knowledge of the law has been recognized by the Texas Board of Legal Specialization, setting him apart from many other injury attorneys. The 22 years he spent as a Municipal Judge, Spring Valley Village, TX also provides him keen insight into the Texas court system. That experience also helps shape his perspective on personal injury cases and how they might resolve. This unique insight benefits his clients. [ Attorney Bio ]