What is Byetta and what are the Risks?

There is recent information that the drug Byetta, marketed for the treatment of type 2 diabetes, carries a risk of acute pancreatitis, pancreatic cancer, thyroid cancer and other serious side effects. Byetta is taken via injection (similar to insulin) and is in a class of drugs known as incretin mimetics. The ingredient in Byetta, Exenatide, imitates the actions of incretin which is normally produced by the intestines to suppress the release of glucose from the liver, slow the emptying of the stomach after a meal which slows the rise of blood glucose, and stimulates beta cells in the pancreas to produce more insulin following a meal. Exenatide can also lead to inflammation of the pancreas from lesions caused by the drug. This inflammation can lead to Byetta acute pancreatitis and pancreatic cancer.

An FDA advisory panel revealed in 2010 that another drug in the same class as Byetta was found to cause thyroid tumors in lab animals. The FDA’s concern was that all extended-release diabetic drugs such as Byetta could increase the risk of thyroid tumors in human beings. The FDA advocated for stronger warning labels to alert Byetta users of the potential risks of thyroid tumors and thyroid cancer. Following the FDA’s report, Byetta company officials conceded that while thyroid cancer in humans taking Byetta had not been definitively proved it could not be ruled out and admitted that female laboratory rats had been noted to show a significant increase in thyroid cancer when given Byetta. A study reported in the journal Gastroenterology placed the risk of thyroid cancer among those taking Byetta at a full 4.7 times higher than those not taking a diabetic drug in this class.

Chronic pancreatitis is a long-term inflammation of the pancreas and is a known risk in the development of pancreatic cancer as is age—nearly nine out of ten of those who develop pancreatic cancer are older than 55 years old. While males are more likely to develop pancreatic cancer, it is believed this is due to greater tobacco use among men. A number of studies as well as reports from patients have suggested a definite connection between the drug and the development of pancreatic cancer. In 2007 and again in 2008, the FDA released warnings to physicians and consumers regarding reports they received of a higher number of acute pancreatitis cases among Byetta users. A study published in Diabetes Care in February, 2010, raised more concerns regarding the increased risk of pancreatitis and pancreatic cancer among those taking Byetta.

Gastroenterology published a study in February, 2011 which not only connected Byetta with pancreatic cancer but possibly with thyroid cancer as well. When adverse event reports submitted to the FDA from 2004 to 2009 were analyzed it was found that Byetta patients developed pancreatitis between six and ten times more frequently and pancreatic cancer almost three times as frequently. Thyroid cancer appeared to occur 4.73 times more often among Byetta users as in the control group. Data identified by the Drug Commission of the German Medical Association and taken from adverse event reports in Germany showed a high correlation between Byetta and pancreatic cancer. This report stated those who had developed pancreatic cancer while taking Byetta developed the disease after approximately 12.2 months on the drug.

A more recent study published in JAMA Internal Medicine in February, 2013, raised considerable concerns relating to the lack of research done by Amylin regarding the potential increased risk of pancreatic cancer. Johns Hopkins researchers studied 2,538 patients with type 2 diabetes. Fifty percent of these patients were hospitalized with acute pancreatitis. When making the necessary adjustments for other pancreatitis risk factors, researchers found that those who had begun taking Byetta within the past 30 days were approximately twice as likely to end up in the hospital with acute pancreatitis.

Byetta may cause kidney function issues among some patients. Those who have a history of kidney problems or have had a kidney transplant should not take Byetta injections. The first sign of kidney problems are generally unexplained changes in urination, swelling or fluid retention in hands or feet and lower back pain. Between April, 2005 and October, 2008, the FDA received 78 reports of kidney issues related to Byetta including renal failure. Ninety-one percent of these 78 patients were hospitalized, eighteen patients required dialysis, two patients underwent kidney transplants and four of the 78 suffered fatal injuries from their kidney problems.

There are a number of known Byetta diabetes medication side effects. It appears that hypoglycemia—severe low blood sugar—may be one such serious Byetta side effect. In clinical trials which occurred prior to approval of Byetta, as many as 35% of those who were taking Byetta along with other diabetic drugs experienced hypoglycemia. Symptoms of hypoglycemia include extreme hunger, irritability, coordination problems, shaking, sweating, blurry vision and dizziness. Should the blood sugar drop in the dangerously low range the diabetic could experience confusion, difficulty speaking, seizures and even coma.

Some patients have experienced allergic reactions to Byetta including unexplained swelling of the face, mouth or throat, breathing difficulties, itching, wheezing, hives or rash. Severe allergic reactions can lead to anaphylaxis which is life-threatening and may cause a sudden blood pressure drop and extreme difficulty breathing. Any swelling, weight gain, decrease in urination, confusion, serious mood changes, a dull pain in the middle or lower back, increased thirst, upper stomach pain or symptoms of low blood sugar can be serious; the patient should discontinue taking Byetta and see a medical professional immediately. Less serious side effects include nausea, upset stomach, mild diarrhea, weight loss or loss of appetite. In rare cases the dermatologic side effect of alopecia has been noted. (Alopecia is loss of hair when the body’s immune system mistakenly attacks the hair follicles.)

Those who have been diagnosed with any of the serious diseases listed above after taking Byetta have important legal rights. It is advisable to review your potential Byetta claim with a highly qualified Sullo & Sullo attorney in order to have a comprehensive evaluation on your specific case. Product liability cases have deadlines, known as the statute of limitations requiring the lawsuits to be filed by a certain date. Our attorneys will take the necessary steps to preserve your case and protect your rights. We have been helping those who have been harmed by dangerous drugs for a very long time and if you have a valid Byetta case, we will help you by guiding you through the process and ensuring your future is fully protected.