Saxagliptin, a diabetes drug sold under the brand names of Onglyza (saxagliptin) and Kombiglyze XR are the focus of a growing number of lawsuits that allege the drugs increase the risk of cardiovascular injury.
It is well-known that diabetics have an increased risk of cardiovascular disease, which is the leading cause of death of diabetics. Understanding the increased cardiovascular risks that type-2 diabetics suffer from, the FDA issued a 2008 memorandum to pharmaceutical companies advising them to demonstrate their products are not associated with an unacceptable increase in cardiovascular risk.
Despite the FDA’s directive, drugmakers AstraZeneca and Bristol-Myers Squibb marketed Onglyza and Kombiglyze without performing adequate trials to assess the of risk of heart failure, congestive heart failure, cardiac failure, and death related to use of saxagliptin.
Following the product’s release, two large clinical trials were conducted which showed that more patients who received saxagliptin were hospitalized for heart failure compared with patients who were given a placebo. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee convened and voted 14 to 1 for the FDA to order the drugmakers to add a heart failure warning to its Saxagliptin drugs. The single member who voted against adding the warning stated a warning was insufficient and the drug should instead be withdrawn from the US market.
Despite the clinical trial findings and despite the FDA Advisory Committee voting to add a warning (or remove the drugs from the market), the drugmakers failed to warn and continued to promote the drug as safe and effective treatment for type-2 diabetes. Numerous individuals, unaware of the risks associated with taking Saxagliptin have suffered serious cardiovascular injuries.
Federal lawsuits have been filed across the country against the drug makers of PPIs. The litigation has been consolidated and is now pending in the Eastern District of Kentucky.
Charles E. Boyk Law Offices, LLC is currently offering free consultations for individuals who may have suffered or been diagnosed a cardiac injury after use of Onglyza or Kombiglyze XR. Our firm is experienced pharmaceutical product liability and dedicated to holding manufacturers of these products liable. Contact us at (877) 277-7336. There is no charge to speak with us or for case evaluations.