Januvia and Byetta Related Deaths

Reports of at least two Byetta deaths from a dangerous form of pancreatitis made headlines back in 2008. The fatalities prompted the U.S. Food and Drug Administration (FDA) to enforce stronger warning labels on incretin mimetics, including Januvia, in regards to adverse side effects like pancreatic inflammation. Since their launch in 2005 and 2006, the type 2 diabetes medications have sparked litigation as patients claim that the drug’s manufacturers failed to warn of serious and life-threatening side effects, which have been blamed on a number of deaths.

The Byetta (exenatide) FDA safety notification to healthcare providers was issued in August 2008 and stated:

“[The] FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting.”

FDA concerned about increasing death toll

Fast forward five years and more than 80 post-marketing reports of Byetta and Januvia deaths – most of them attributed to necrotizing pancreatitis and pancreatic cancer. The FDA is now taking a much closer look at pancreatic cancer risks from Merck’s Januvia and Bristol-Myers Squibb’s Byetta.

In March 2013, federal regulators announced an investigation of a potential connection between Januvia and Byetta and acute pancreatitis and pre-cancerous changes to the pancreas. The results of the FDA review may change how millions of Americans choose to treat their diabetes, and shed light on escalating allegations of wrongful deaths from Januvia and Byetta.

Byetta and Januvia are also known as GLP-1 receptor agonists and DPP-4 inhibitors, a class of drugs that help stabilize blood sugar levels by stimulating the release of insulin after a meal. Insulin is the primary hormone responsible for controlling glucose levels in the blood. The incretin mimetics also function by preventing the pancreas from putting out excess glucagon, which triggers the liver to release stored sugar in the bloodstream.

Produced by Merck, Januvia is one of the nation’s top selling diabetes drugs, with revenues exceeding $2.6 billion last year. Byetta is another blockbuster treatment, earning Bristol Myer Squibb some $460 million in 2012.

Both drug manufacturers vehemently defend their products and deny any liability for alleged Januvia and Byetta deaths. Merck told Bloomberg News that it finds “no compelling evidence of a causal relationship” between Januvia and pancreatic cancer, while Bristol-Myers backs its Byetta saying exenatide has a “positive benefit-risk profile.”

Emerging research points to Byetta and Januvia pancreatic risks

In the majority of Byetta and Januvia lawsuits that allege wrongful death, the purported cause is sudden onset pancreatitis or pancreatic cancer. A 2013 study published in the journal JAMA Internal Medicine showed that patients who take incretin mimetics have twice the risk of developing acute pancreatitis.

The symptoms of acute pancreatitis include:

• Loss of appetite
• Severe abdominal pain
• Persistent nausea
• Vomiting
• Fever
• Jaundice

The medical community has been on high alert regarding Byetta and Januvia pancreatitis, ever since the journal Gastroenterology published a study that showed “sitagliptin or exenatide increased the odds ratio for reported pancreatitis 6-fold.” The research was conducted by endocrinologist Peter Butler and colleagues, who used figures from the FDA’s adverse event database. Since all forms of pancreatitis predispose patients to cancer of the pancreas – one of the most deadly types of cancer – these clinical findings may bolster allegations that Byetta and Januvia are unreasonably dangerous drugs which have caused an alarming number of fatalities.

Acute pancreatitis linked to Byetta and Januvia death

Over the past two years the FDA has been bombarded with thousands of adverse event reports concerning Januvia and Byetta. Januvia was linked to 184 incidents of acute pancreatitis – a definite risk factor for pancreatic cancer; while 1,304 cases were associated with exposure to Byetta. Since acute pancreatitis is associated with possible death, early detection is key for patients.

The journal Diabetes Care voiced concerns about Byetta and pancreatic cancer by stating: “We feel that enough preliminary evidence has accumulated to suggest that there is a plausible risk that long-term recipients of GLP-1–based therapy may develop asymptomatic chronic pancreatitis (Fig. 1), and worse, subsequently a minority of individuals treated by this class of drug may develop pancreatic cancer.”

Byetta and Januvia lawsuits claim wrongful death

Testimonies of Byetta and Januvia death continue to flood court rooms throughout the nation, as bereaved family members seek justice and fair compensation for the premature loss of a loved one. While a definitive correlation between Byetta and Januvia and pancreatic cancer has yet to be confirmed by the FDA, consumers are taking legal action regarding misinformation and failure of the drug makers to adequately warn of adverse reactions and pancreatitis risks.

Notable victims who have taken Big Pharma to court:

• On June 28, Rebecca Richard filed a Byetta death lawsuit in California district court, alleging her deceased husband developed pancreatic cancer from Byetta. The widow seeks compensatory and punitive damages against Eli Lilly and Amylin Pharmaceuticals.
• A wrongful death claim was brought against Merck on March 29, based on allegations that Januvia is defective and caused fatal pancreatic cancer in three patients. The plaintiffs contend that Merck failed to warn of Januvia risks.
• Regina Kelly was diagnosed with pancreatic cancer after taking Byetta and Januvia. After she lost her battle with the disease, her estate filed suit arguing the medications caused her untimely death. The complaint seeks compensation for Ms. Kelly’s physical and mental injuries, medical expenses, in addition to punitive damages.