In December of 2008, the Food and Drug Administration made requirements for drug companies and manufacturers to conduct studies to show that new diabetes drugs do not increase cardiovascular risk compared with current treatments. The guidance was developed amid growing concern about the safety of many diabetes drugs. AstraZeneca sponsored a trial of over sixteen thousand patients known as SAVOR previously showed patients taking Onglyza, also known as saxagliptin, had an increased risk of hospitalization due to heart failure. The company claims that it conducted the SAVOR study in accordance with the 2008 guidance and that the results met the objective of showing that patients taking Onglyza were not at greater risk as measured by a composite benchmark comprising cardiovascular death, non-fatal heart attack and non-fatal ischemic stroke.
The Food and Drug Administration’s analysis revealed that the heart failure was valid. It also showed a possible increased risk of death from all causes. The Food and Drug Administration’s review stated that, “The overall trial results did not reveal a higher death risk, but a more detailed analysis examining only patients who took the drug suggests a significantly increased risk of all-cause mortality.” The agency stated that the causes of death were often multifactorial and some patients may have had several serious medical conditions in the days and weeks prior to death. The agency state that it is not reassured by the risk, however, and does not necessarily view this pattern of variable causes as evidence the mortality signal is due to chance.
An analyst for Leerink stated that the Food and Drug Administration’s concerns over all-cause mortality were unexpected and could lead to a cut of up to 50 percent in his $1.8 billion peak annual sales estimate, if Merck & Co’s rival drug Januvia does not show similar problems.
The company that AstraZeneca is committed to ensuring patient safety and will continue to work closely with the FDA to support further review of the data. According to a preliminary review of data from the U.S. Food and Drug Administration Onglyza produced by AstraZeneca, may be linked to an increased death rate. Onglyza was approved in 2009.
If you or someone you love has experienced heart failure, other problems, or even died after taking Onglyza, it is advised that you contact one of our caring and knowledgeable Onglyza and dangerous drug attorneys at the Higgins Firm. We understand how hard this must be for you and your family. We help to make the process as smoothly as possible. Currently we are working with other firms across the country to investigate these claims. Along with these other firms, we will review your case, gather any necessary evidence, and fight for you to see to it that you receive any compensation that is rightfully yours for what you have been through.
It should be noted that if you are currently taking Ongylza, you should speak with your doctor before changing or altering your medications. Your doctor should be able to discuss the merits of these studies and determine what is best for you.