It should be troubling to all users of Onglyza and Kombiglyze XR that the largest pharmacy benefits manager in the United States, Express Scripts has dropped the Type 2 Diabetes medication. Express Scripts stated that the drug’s side effects were too concerning. Why is a corporation refusing to injury people, yet the FDA still won’t issue a recall?
Express Scripts showed concerned over thousands experiencing heart failure from Onglyza. They cited a 2016 advisory committee’s ruling that the medication brings a 27% higher risk of heart failure that requires hospitalization. However, the label does not adequately warn consumers of this increased risk.
FDA & Onglyza
The FDA approved Onglyza in 2009 and Kombiglyze XR in 2010. Both drugs are DPP-4 inhibitors that work by reducing the amount of sugar produced in the liver. It also helps the body produce more insulin after meals. The FDA first began investigating these drugs for increased risk of pancreatitis before connecting it to heart failure as well.
The FDA re-evaluated two large clinical trials that focused on patients with heart disease. The trial showed that 35 out of every 1,000 patients who received saxagliptin-containing drugs ended up in the hospital. This is 10% more than those who received the placebo.
Along with the mandated label changes for Onglyza and Kombiglyze XR reflecting the heart failure risk, the FDA strongly recommends medical personnel to discontinue all saxagliptin-containing medication when a patient develops heart failure. Unfortunately, this labeling did not come soon enough. A study published nearly four years ago showed that almost 20% of participants had an adverse reaction to saxagliptin and nearly 5% died. Many people could have been saved.
Yet, the FDA still has not issued a recall of the drug.
Express Scripts & Onglyza
Express Scripts did not see Onglyza having an added benefit over other DPP-4 inhibitors. They examed multiple studies including one by The German Institute for Quality and Efficiency in Health Care (IQWiG). IQWIG found Onglyza and Kombiglyze XR were more harmful to patients than any other drug in the same class.
If you or a loved one experienced heart failure after taking Onglyza or Kombiglyze XR, contact the dedicated consumer attorneys at The Michael Brady Lynch Firm, today at 877-513-9517.