After conducting a preliminary review of data, the U.S. Food and Drug Administration (FDA) has issued a report indicating that AstraZeneca’s diabetes drug Onglyza may be linked with an increased rate of death. According to Reuters, an FDA advisory panel will meet on April 14 to discuss he risks of Onglyza and another similar drug.
Previous findings from the SAVOR trial, which was comprised of 16,000 patients taking Onglyza, showed that the drug was associated with an increased risk of hospitalization due to heart failure. The FDA reviewed the data and determined that the risk of heart failure is legitimate. Additionally, the FDA found that Onglyza may be linked to an increased risk of death from all causes. Even though the overall trial results did not point to an increased death risk, the agency’s review found that the drug may pose “a significantly increased risk of all-cause mortality,” upon further analysis.
The causes of death were frequently “multifactorial” and in some cases patients had several serious medical conditions beforehand, the FDA said.
The FDA mandated that drug companies study the cardiovascular risk associated with new diabetes drugs in 2008. The guidance was issue due to mounting concerns about the dangerous of diabetes medications.
Read more at: Onglyza Side Effects: Heart Failure Lawsuits