Bristol-Myers Squibb Co. (BMS) and AstraZeneca (AZ) Pharmaceuticals are facing numerous lawsuits claiming the companies failed to follow U.S. Food and Drug Administration recommendations to warn diabetes patients of cardiovascular risks associated with drugs containing saxagliptin and alogliptin.
The FDA released a warning in 2014 that the drugs Onglyza, Kombiglyze XR, Nesina, Kazano, and Oseni may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.
The drugs, on the market since 2009, are used to treat type 2 diabetes. They are part of the class of dipeptidyl peptidase-4 (DPP-4) inhibitor drugs, which are prescribed with diet and exercise to lower blood sugar level in adults with type 2 diabetes. DPP-4 is the enzyme responsible for rapidly degrading incretin hormones released by the gut in response to food. Unabated, type 2 diabetes leads to serious health problems, including blindness, nerve and kidney damage, and heart disease. DPP-4 inhibitors like saxagliptin were generally thought to have a good safety profile. The most common side effect patients complained about was nasal pharyngitis, a fancy way of saying a running nose.
Type 2 diabetes mellitus is a chronic disease, characterized by insulin resistance and deficient insulin secretion leading to high blood sugar levels and hyperglycemia. Type 2 diabetics have an increased risk of cardiovascular disease, which is the leading cause of morbidity and mortality in the patient population.
The DPP-4 inhibitors found in Saxagliptin, which is sold as Onglyza (saxagliptin combined with metformin is sold as Kombiglyze). Onglyza inhibits natural enzymes and enables the stimulation of insulin to continue longer than what naturally occurs after meals. The drugs manipulate the natural biological incretin effect allowing the process to maintain a much more extended period then occurs naturally.
Victims' lawyers have long targeted diabetes drugs in litigation because drug companies do not want to warn of all of the risks out of fear that doctors will prescribe their drug less. Diabetes drugs are very lucrative for drug companies and the competition is intense.
The latest iteration of drugs for diabetes is known as the "Incretin Mimetic" class. This class of drugs includes both glucagon-like peptide-1 (GLP-1) receptor agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors like Januvia and Onglyza. Incretin Mimetics mimic the body's natural incretin hormones to stimulate the release of insulin during and after meal. Onglyza was approved by the FDA on July 31, 2009 and quickly garnished market share in the diabetes drug marketplace.
A full year before the drug hit the market, the FDA issued a memorandum entitled, "Final Guidance for Industry, Diabetes Mellitus: Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes," which stated applicants of new anti-diabetic medications should perform adequate clinical trials to determine if their drugs created risk of heart failure, congestive heart failure, or cardiac failure. Despite the recommendation, the companies marketed and sold Saxagliptin for many years before finally adding the warnings.
Why? Again, no one knows exactly why. But what we do know is that drugs make pharmaceutical companies a fortune and the way to start selling less a drug is when you start making it clear that there are real risks associated with the product that your competitors do not have. Doctors read the warnings and they are risk adverse when it comes to their patients.
Attorneys at Miller & Zois believe that these Onglyza lawsuits are going to be very difficult to defend due to some of the decisions the drug companies made when the drugs became available to the public. The lawsuits allege that BMS and AZ ignored the FDA guidance and put Onglyza on the market without conducting crucial testing on cardiovascular safety.
This looks really bad for the drug companies and could heavily influence a jury at trial. It makes it seem like these companies may have rushed the drug to the market for financial reasons fully appreciating and warning of the risk of these drugs. That is the key. No one is arguing there should be a Onglyza recall. For some people, the heart failure risk might be worth the benefits of the drug. But Bristol Myers and AstraZeneca will have a tough time defending their decision to continue to sell the drug for several more years without updating warnings about the risks despite the FDA's recommendation to do so.
An April 2018 lawsuit filed in a U.S. District Court in Ohio said, "[a] reasonable person who had actual knowledge of the increased risks associated with using the drugs would have concluded that Onglyza and saxagliptin should not have been marketed to or used by Decedent and his physicians."
Another lawsuit filed in a U.S. District Court in New Jersey said, "[d]efendants acted in concert with one another to fraudulently convey false and misleading information concerning the safety and efficacy of Saxagliptin and to conceal the risks of serious adverse events, including heart failure, congestive heart failure, cardiac failure, death from heart failure and other adverse effects associated with Saxagliptin from the public, the Plaintiff, physicians, and other healthcare providers.
Findings of the risks of the drugs published in the New England Journal of Medicine in 2013 prompted the FDA advisory committee to vote 13 to one in favor of adding heart failure warnings to the drugs. The one member who voted against the warnings believed a recall of the drug should take place because it was so unsafe. Despite the recommendation, BMS and AZ still didn't add the warnings for a couple years.
The FDA trial showed that "3.5 percent of patients who received the drugs were hospitalized for heart failure versus 2.8 percent of patients who received a placebo. This is the same as 35 out of every 1,000 patients compared to 28 out of every 1,000 patients. Risk factors included a history of heart failure or kidney impairment. In the alogliptin trial, 3.9 percent of alogliptin-treated patients were hospitalized for heart failure versus 3.3% in the placebo group. This is the same as 39 out of every 1,000 patients compared to 33 out of every 1,000 patients."
The FDA report also claims that 386,000 patients received a dispensed prescription for saxagliptin-containing products (saxagliptin and saxagliptin-metformin), and 56,000 patients received a dispensed prescription for alogliptin-containing products (alogliptin, alogliptin-pioglitazone, and alogliptin-metformin) from the U.S. outpatient retail pharmacy setting.
Patients taking these medicines should contact their health care professionals right away if they develop signs and symptoms of heart failure such as unusual shortness of breath during daily activities, trouble breathing when lying down, tiredness, weakness, or fatigue, weight gain with swelling in the ankles, feet, legs, or stomach.
Healthcare professionals should consider discontinuing the medicine in patients who develop heart failure and monitor their diabetes control. If a patient's blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required.
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.