FDA Advisory Panel Recommends Heart Failure Warnings on Containers of Onglyza

An FDA advisory panel voted recently to recommend that labels for Onglyza should include warnings regarding an increased risk of heart failure.  The result of this vote comes on the heels of a massive study that led to troubling results for many.  Onglyza is a diabetes medication that is manufactured by AstraZeneca, one of the true giants of the pharmaceutical industry.  The vote to recommend warnings on labels of Onglyza was seen as reaching a moderate result.  That’s because the panel could have voted to limit the use of the drug or to recommend that it be pulled from the market altogether.

What Is Onglyza?

Onglyza is a medication that is prescribed for treatment of symptoms of type 2 diabetes.  It is a member of a class of drugs known as DPP-4 Inhibitors.  Other brands that are members of this class are Januvia which is manufactured by Merck and Nesina, which is manufactured by Takeda.  Onglyza was originally approved for use in the United States by the FDA in 2009.  The drug was initially a joint venture between AstraZeneca and Bristol-Myers Squibb.  In 2013, AstraZeneca bought out Bristol-Myers Squibb’s interest in the medication.  Onglyza generates hundreds of millions of dollars in revenue for the manufacturer on an annual basis.

The SAVOR Study

The FDA advisory panel that voted on Onglyza did so after reviewing the data from a massive outcomes study known as SAVOR.  The study included more than 16,000 human subjects.  One group in the study was given a prescription of Onglyza and the other served as a control group.  The results indicated that the group that used Onglyza faced a greater risk by a factor of 27 percent of facing hospitalizations because of heart failure.  The panel called this heightened risk “statistically significant” in nature.

Onglyza and Heart Failure Risks

There were at least two reasons as to why the panel did not vote to remove Onglyza from the market, according to industry experts.  One is that all patients with type 2 diabetes face an increased risk for heart failure.  The other was that the reasons for the heart failure suffered by those who were hospitalized during the study were varied and could not definitively be attached to the use of Onglyza without further, specific study.  The SAVOR study was not necessarily designed to test whether or not the use of this medication led to this outcome.

Onglyza Side Effects and Your Legal Rights

Clearly, the FDA feels that there is enough of a risk of heart failure to recommend warnings on the labels of Onglyza.  This should be noted by anyone who is using this medication.  If you or someone you love has used this drug and suffered as a result, you need to take immediate action to protect your legal rights.  You can do so by contacting the Onglyza side effects lawyers at Parilman & Associates today to schedule a free initial consultation.  You can either email the firm or call 800-800-DRUG.