According to the findings of an important new report, thousands of people have been injured or killed due to dangerous side effects of diabetes drugs like Byetta and Januvia, thanks to the ineffectiveness of the U.S. Food and Drug Administration’s (FDA) medication approval process. In an investigation into pharmaceutical drug approvals by the FDA, MedPage Today and the Milwaukee Journal Sentinel claim to have discovered significant shortcomings plaguing the agency’s system, allowing potentially dangerous drugs to make it through the approval process and onto pharmacy shelves. The report notes specific concerns in how the FDA treats Byetta, Januvia and similar diabetes drugs, which have been linked to potentially life-threatening side effects like pancreatitis and pancreatic cancer.
In the Milwaukee Journal Sentinel/MedPage Today report, investigators indicate that, in the process of approving pharmaceutical drugs, the FDA relies heavily on so-called surrogate measures, rather than proof that patients who use the medications actually live longer. For example, when determining whether diabetes drugs will be approved and permitted to go to market, the agency looks at the effects of the medications on glucose levels, as opposed to looking at whether the person taking the drug actually goes on to live a longer life. According to critics, this means that, when it comes to controversial diabetes drugs like Byetta and Januvia, the FDA might note that the drugs lower blood glucose levels or stimulate insulin production, without recognizing the fact that many patients were later diagnosed with pancreatic cancer and died.
Byetta, Januvia and Victoza all belong to a class of diabetes drugs known as incretin mimetics, which function by mimicking the incretin hormones the body usually produces in order to stimulate the release of insulin in response to a meal. Despite the fact that these drugs have become some of the most popular diabetes medications on the market, a growing body of research has indicated that incretin mimetics like Byetta and Januvia may actually increase a patient’s risk of devastating side effects, like pancreatitis possibly leading to pancreatic cancer. There are currently more than 500 Byetta, Januvia, Janumet and Victoza lawsuits pending in the federal court system, all of which involve similar allegations that the makers of these diabetes medications developed and sold defective drugs.
Investigators involved in the report analyzed case reports from 2004 to 2014, submitted to the FDA’s Adverse Events Reporting System, and found that side effects of Byetta, Januvia, Victoza and similar diabetes drugs accounted for approximately 20,000 hospitalizations and 3,300 deaths. Based on these findings, the investigators noted that while Byetta, Januvia and Victoza combined make up only 7% of all diabetes drug prescriptions in the United States, the medications accounted for more than half of the hospitalizations and deaths associated with diabetes drugs in 2013. And, since many health experts say that only a small percentage of adverse drug events are actually reported to the FDA, the actual number of hospitalizations and fatalities linked to the diabetes drugs could be as high as ten-fold the number reported.
As more information comes to light about the risk of pancreatitis and pancreatic cancer from Byetta and similar diabetes drugs, a growing number of patients are filing drug injury lawsuits in courts across the country, alleging that the makers of Byetta and Januvia failed to provide consumers and the medical community with adequate warnings about the risk of deadly side effects associated with the diabetes drugs. If you believe you have been adversely affected by side effects of Byetta or another allegedly dangerous drug, our consumer advocates at the Consumer Justice Foundation can help. We are committed to protecting the rights of consumers harmed by potentially defective medications, and can help put you in touch with a reputable attorney who has experience handling Byetta injury claims.
[box type=”note” align=”aligncenter” ]Source: http://www.medpagetoday.com/Endocrinology/Diabetes/49221s[/box]