FDA Finally Admits Onglyza Causes Heart Failure
This is Amy German, Managing Associate attorney for the Michael Brady Lynch Firm.
Two years after the FDA promised to look into claims of heart failure in patients taking medications containing saxagliptin such as the popular diabetes medications Onglyza and Kombiglyze XR, the agency at long last acknowledged the risks that consumer advocates have warned about for years. The FDA finally mandated a labeling for all drugs containing saxagliptin warning of a risk of heart failure.
High Onglyza Heart Failure Rates
For years, studies have shown that patients taking Onglyza or Kombiglyze XR have an almost 30% increased risk of heart failure. This number grows in those already with heart or kidney disease.
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 were hospitalized. 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. They also advised of additional warning signs or symptoms that will need to be evaluated by a healthcare professional right away:
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
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. Once again, the FDA has let down the American consumer.
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.