What is Byetta?

Byetta, an injectable drug used in the treatment of type 2 diabetes, contains Exenatide, a drug which is a synthetic form of a substance found in Gila monster saliva. Exenatide is in a class of drugs known as incretin mimetics as it mimics the effects of incretins--hormones which are produced and released into the blood by the intestine in response to food. These hormones—such as human-glucagon-like peptide-1 (GLP-1) increase the secretion of insulin from the pancreas, slow the absorption of glucose from the stomach, and reduce the action of glucagon—a hormone which increases the liver’s production of glucose.

GLP-1 has also been found to reduce the appetite; in studies patients treated with Exenatide achieved lower blood glucose levels and experienced higher levels of weight loss, however the drug is not approved for off-label weight loss use. Manufactured by Amylin Pharmaceuticals, Inc., in collaboration with Eli Lilly & Co., Byetta is generally injected twice daily in the stomach, upper thigh or upper arm prior to the morning and evening meals. Byetta has been used by more than a million patients since its introduction in April, 2005.

Both Byetta (Exenatide) and Januvia (Sitagliptin) increase the amounts of the body’s GLP-1 hormone which stimulates the pancreas to produce more insulin. When the pancreas is producing GLP-1, it may also produce certain digestive enzymes which, if activated prior to leaving the pancreas, can digest the tissues of the pancreas. This digestion of tissue can lead to inflammation, abdominal pain, fever and nausea.

According to a study published on February 25, 2013 in the JAMA Internal Medicine Journal, Byetta was found to cause twice the number of pancreatitis attacks in patients which were severe enough in nature to land them in the hospital. These patients were found to have pancreatic lesions which were believed to be caused by the drug Byetta. While pancreatitis is more common among diabetics, affecting 3 in 1,000 diabetes patients, the number doubles to 6 in 1,000 for those taking Byetta.

In 2008, Byetta was linked to six deaths; two of those deaths were reported in an FDA Safety Communication while an additional four deaths were reported by officials from Eli Lilly & Co. and Amylin Pharmaceuticals. (Amylin and Eli Lilly dissolved their partnership in 2011, with Amylin gaining “custody” of Byetta although Lilly will continue to get a cut of all future Byetta sales. Then in 2012, Amylin sold out to Bristol-Myers Squibb for $5.3 billion)

Since 2008 there is the possibility that more people have suffered fatal side effects from taking Byetta as it has been linked to severe pancreatitis, pancreatic cancer which has a high fatality rate, thyroid cancer and even kidney failure. Bear in mind that between 2005 and 2009 more than 7 million prescriptions were issued for Byetta with six deaths reported. A 2011 study published in Gastroenterology states that over 1,000 people taking Byetta have been diagnosed with pancreatitis while at least 375 have been diagnosed with thyroid or pancreatic cancer.

Some of the more common side effects of the drug Byetta include dizziness, diarrhea and nausea. Severe diarrhea or signs of an allergic reaction are considered more serious side effects and should be discussed with a physician immediately. Approximately 44% of all those taking Byetta will develop nausea, while 13% will experience vomiting and diarrhea. Nine percent of those taking Byetta will feel jittery or dizzy and will suffer headaches. Upset stomach and heartburn will affect up to 6% of those taking Byetta.

Other side effects which occur in approximately 5 percent of those taking Byetta include weakness, decreased appetite, gastroesophageal reflux disease and increased sweating. Symptoms of low blood sugar can occur if Byetta is taken with other diabetes drugs. These symptoms can include a shaky feeling, unusual perspiration, extreme hunger, blurry vision, irritability, loss of coordination and even difficulty speaking, confusion and seizures. Those who experience an unexplained change in urine output, swelling in hands or feet or a dull ache in the mid or lower back area should see a doctor immediately as a more serious problem such as pancreatitis could be indicated.

Byetta has been linked to life-threatening pancreatic problems including pancreatic cancer. The FDA received more than thirty reports of acute pancreatitis from Byetta users in addition to two deaths and four hospitalizations. The FDA ordered Amylin to conduct six post-marketing studies which would give some insight into the incidence and risk factors for the development of acute pancreatitis and pancreatic cancer. Chronic pancreatitis and acute pancreatitis are often precursors to pancreatic cancer which has a very low survival rate. In fact, only about 3% of those diagnosed with pancreatic cancer will live past five years following their diagnosis. This is due in part to the fact that pancreatic cancer has progressed far past the initial stage by the time it is diagnosed. Pancreatitis symptoms include acute abdominal pain, fever, vomiting and nausea, a swollen or tender abdomen, changes in bowel movements and a rapid heartbeat.

In 2010 an FDA advisory panel revealed that a drug in the same class as Byetta was responsible for a higher-than-normal number of thyroid tumors in lab animals. The FDA expressed concern that all the extended-release diabetic drugs in this category could be responsible for thyroid tumors in humans as well, and directed Amylin (and Eli Lilly at that time) to provide stricter labeling for Byetta which would alert users to the potential risks of the drug, including thyroid tumors and thyroid cancer. One study reported on by Dr. Peter Butler and published in the journal Gastroenterology placed the risk of thyroid cancer at 4.7 times that of the person not taking Byetta, however the manufacturer disputes this number. Amylin does concede that because of the higher number of thyroid tumors among female laboratory rats when given drugs such as Byetta some caution is warranted among Byetta users. Until more studies are conducted there is no definitive answer as to whether Byetta definitely increases the risk of thyroid cancer among users however the evidence thus far appears to point to a significant risk.

Many believe that pure greed kept Amylin Pharmaceuticals from ensuring consumers were aware of the potential risks of Byetta. Considering Amylin was manufacturing only three drugs in 2012 at the time the company was acquired by Bristol-Myers-Squibb for $5.3 billion dollars, it does appear that there may have been a failure to warn on the part of Amylin. This failure to warn included:

• Keeping any mention of the risks of pancreatic cancer from the Byetta label
• Neglecting to advise physicians to carefully monitor their patients taking Byetta for any changes to the pancreas
• Failing to sufficiently test Byetta—only one small clinical trial involving a short-term treatment was undertaken prior to marketing the drug.
• Failing to neglect a Byetta recall even after it seemed clear that the risks could outweigh the benefits.

Byetta has not yet been recalled, although the FDA issued an alert to doctors only two years after the drug began being sold. This alert informed physicians that after reviewing thirty reports of acute pancreatitis among those taking Byetta there was sufficient evidence to suggest an association between Byetta and acute pancreatitis. In six of the thirty patients the symptoms of pancreatitis either began or became considerably worse soon after their doctor increased their dosage of Byetta. Pancreatitis symptoms of twenty-two of the patients showed marked improvement after discontinuing Byetta, and in three of those patients, the pancreatitis returned when Byetta was resumed. Although lawsuits are being filed against the manufacturer of Byetta, a recall does not appear to be imminent.

Rather than recalling Byetta or even providing warnings to consumers and physicians regarding the importance of monitoring changes in the pancreas, Amylin both continued to push sales of Byetta and withheld information regarding efforts to gain approval of a new drug, Bydureon. Bydureon is a long acting once-weekly version of Byetta which was approved in early 2012; studies show that this drug may bring an even higher risk of thyroid cancer than Byetta. Any person who has taken Byetta and experienced adverse health symptoms should consult an attorney to discuss their options. The attorneys of Sullo & Sullo, LLP have extensive knowledge and experience in product liability cases and a thorough understanding of the Byetta drug, the side effects, and Amylin’s apparent failure to warn.

Your specific Byetta damages will, of course, be based on the level of harm you suffered from the drug. Due to the serious nature of pancreatic cancer and pancreatitis which can lead to pancreatic cancer, those who have suffered such medical issues from Byetta may be entitled to compensation for their medical expenses, lost wages and pain and suffering. Your Sullo & Sullo attorney will better be able to assess your particular case and give you some idea of the potential damages after speaking with you and thoroughly assessing your specific case facts.

The very best way to fully protect your Byetta case is to speak with a knowledgeable Sullo & Sullo lawyer as soon as possible. Our attorneys are experts in the field of product liability law and fully understand how the statute of limitations can affect your potential case. After assessing your Byetta case, our attorneys will aggressively protect your rights regardless of the extent of the injuries you received from Byetta, filing your claim in a timely, professional manner.

Depending on which state you reside in, your statute of limitations for a product liability case could range from one year to five years. Most of the states operate under a two-year statute of limitations, including the state of Texas. If a drug or medical device is recalled, the day of the recall is generally when the statute of limitations begins running. The lines can be much fuzzier if there was no recall. Some companies will claim a warning issued to consumers is sufficient to start the statute of limitations while other times the statute may begin when your adverse symptoms begin, assuming there was no recall. To ensure you do not miss the statute of limitations, or even if it appears you have already missed it, speak to a qualified Sullo & Sullo attorney immediately as there are instances in which the statute may be extended.

Byetta is not the only diabetes drug under fire; others are also laboring under claims from consumers who have developed pancreatitis, pancreatic cancer, thyroid cancer or other adverse health effects. Because of the amount of money big drug companies make from such drugs as Byetta, they have the resources to fight charges of failure to warn or defective drug in court and most of the time will attempt to blame the patient’s health problems on pre-existing conditions or other health issues. Because these companies can be ruthless as they defend their decision to leave a harmful drug on the market, it is crucial that you have a Sullo & Sullo attorney by your side from start to finish.