Questions about the Diabetic Drug Byetta

Is Byetta Linked to Pancreatic and Thyroid Cancer?

Those patients with Type 2 diabetes may have heard about potential problems with the diabetic drug Byetta, and are wondering whether Byetta has actually been linked to pancreatic cancer and thyroid cancer. Between 2005 when Byetta gained FDA approval and 2007, the FDA received 30 reports of acute pancreatitis. The next year six more people reported suffering acute pancreatitis after beginning Byetta. Two of those six patients died while the other four spent considerable time in the hospital. Those who develop pancreatic cancer likely have a history of pancreatitis, perhaps from taking Byetta. Unfortunately, pancreatic cancer has a very low survival rate and is generally diagnosed in the latter stages.

Symptoms of pancreatitis include severe pain in the abdomen, nausea, fever and vomiting and, in some cases, changes in bowel movements, a rapid heartbeat and swelling in the abdominal area. Although the various studies differ in the exact numbers, overall it appears there is a six-fold increase in pancreatitis, a three-fold increase in pancreatic cancer and a two-fold increase in thyroid cancer among Byetta users. The FDA required the manufacturer to increase the warnings on Byetta labels first in 2007, again in 2008 and once again in 2009.

The labeling noted the potential risks of Byetta, particularly pancreatitis, pancreatic cancer, Byetta thyroid cancer and renal failure. A 2010 FDA advisory panel pointed to the fact that exenatide was responsible for a higher than normal number of thyroid tumors among laboratory rats. The FDA expressed alarm regarding the huge number of extended release diabetic drugs currently being taken in the United States by diabetics, noting the potential of thyroid tumors among humans as well.

Did the Manufacturer of Byetta Exhibit a Failure to Warn?

Although there has been no recall of Byetta as of this writing, lawsuits continue to mount. Those who were harmed by a drug they believed to be safe are consulting attorneys to file a Byetta lawsuit. As with many cases involving dangerous drugs and huge pharmaceutical companies many wonder whether Amylin exhibited a failure to warn consumers.

The failure to warn allegation may include the failure to sufficiently test Byetta, the failure to advise physicians to monitor patients taking Byetta carefully for signs of pancreatitis and the failure to mention the risk of pancreatic cancer on the original Byetta labeling.

If you believe you have a Byetta thyroid cancer lawsuit, it could be advantageous for you to speak with a knowledgeable Byetta attorney, as you may be entitled to compensation for your medical expenses, pain and suffering and lost wages associated with Byetta.

Byetta Thyroid Cancer Safety Concerns

Byetta, a drug marketed for the treatment of Type 2 diabetes, has come under fire for potential problems including a greater risk of thyroid cancer, pancreatitis and pancreatic cancer. The active ingredient in Byetta is exenatide, originally manufactured by Amylin Pharmaceuticals. Exenatide is a synthetic version of a hormone found in the saliva of the desert Gila monster. Byetta comes in a pre-filled pen which the patient injects into the stomach, thigh or upper arm, within an hour prior to breakfast and dinner. The synthetic hormone is also fifty percent identical to a hormone known as GLP-1 which is found naturally in the human digestive tract. GLP-1 increases insulin in the body to balance out blood sugar when it is higher than it should be.

Potential Byetta Dangers

Byetta has also been found to cause weight loss as it slows the rate at which the stomach empties although patients are cautioned against using Byetta as a weight loss drug. Though Byetta gained FDA approval in 2005, adverse reports soon began filtering in of potential Byetta dangers. Thyroid cancer, pancreatitis and pancreatic cancer all appear to occur more often among those taking exenatide than in those taking certain other diabetic drugs. It has been found that people bitten by a real Gila monster tend to be at a much higher risk of developing pancreatitis as the hormone in the saliva of the reptile overstimulates the pancreas. This overstimulation may result in pancreatitis and repeated bouts of pancreatitis can set the stage for pancreatic cancer.

Information Regarding Byetta

Over 700,000 people have been prescribed Byetta since its approval in 2005—in 2007 thirty post-marketing reports of Byetta patients who developed acute pancreatitis were sent to the FDA. While this may not seem like a huge number considering the amount of people taking the drug, since that time many more reports have occurred. Of the original 30, 22 showed immediate improvement of their pancreatitis symptoms once Byetta was discontinued. In 2006 Diabetes Care Journal reported a case of a 69-year old man taking Byetta who developed pancreatitis symptoms within 24 hours of beginning the drug.

Risks of Byetta

Byetta patients may have as much as a three-fold risk of developing pancreatic cancer and a six-fold risk of developing acute pancreatitis. The risk of Byetta thyroid cancer appears to be at least two times the rate of that for other diabetics according to a recent study published in the Institute for Safe Medication Practices. Although Byetta thyroid cancer is considered much more treatable than pancreatic cancer, it is nevertheless a serious disease.  The American Gastroenterology Association reports in its official newspaper that more studies are needed in order to determine the specific risks associated with Byetta.

Other Potential Side Effects of Byetta

Aside from the potential risks of Byetta pancreatitis, thyroid tumors and thyroid cancer and pancreatic cancer, in some cases Byetta can cause a severe allergic reaction which causes swelling of the face, lips, throat or tongue or severe shortness of breath. A constant dull pain in the middle or lower back, severe pain in the upper stomach, jaundice, confusions, unusual drowsiness, extreme mood changes or a decrease in urination are other potential side effects of Byetta.

Byetta FDA Safety Concerns

Over 700,000 patients have used the drug Byetta since it received FDA approval in 2005. By 2007, however, Byetta FDA warnings were being issued regarding potential dangers of the drug including thyroid cancer, pancreatitis and pancreatic cancer. Thirty adverse reports came in to the FDA between 2005 and 2007, then in the following year six cases of necrotizing pancreatitis were reported as well, with two fatalities among those six Byetta patients.

What is Byetta?

Byetta is a twice-daily injectable drug used in the treatment of Type 2 diabetes. The drug’s active ingredient, exenatide, is a synthetic form of the saliva of the Southwestern Gila monster, and is fifty percent identical to the GLP-1 hormone found naturally in the human digestive tract. GLP-1 works by increasing the body’s insulin in order to balance blood sugar. The synthetic form of this hormone remains effective for a longer period of time than the hormone which occurs naturally in the body. Byetta’s “perk” is that it appears to cause weight loss due to slowing the rate at which the stomach empties—although patients are cautioned against using Byetta as a treatment for obesity.

Byetta FDA Warnings

Byetta FDA warnings came in 2007, 2008 and 2009 as more adverse reports filtered in to the agency. Following thirty reports between 2005 and 2007 of Byetta users who developed pancreatitis—some cases serious enough to require hospitalization—the FDA upped the labeling requirements of Byetta to include a caution to physicians to warn their patients to seek medical assistance should they experience any symptoms of pancreatitis. In 2008—following the six reported cases of necrotizing or hemorrhagic pancreatitis—Byetta thyroid cancer FDA safety concerns amplified. The four living patients were taken off Byetta and Amylin, along with partner Eli Lilly, was ordered to add labeling warnings to patients to discontinue Byetta and see their physician if they experienced any symptoms of pancreatitis. Further, any patients receiving a diagnosis of pancreatitis were instructed to consider another drug to treat their Type 2 diabetes.

Potential Byetta Dangers

By 2009, 78 reports of renal issues had been reported to the FDA from Byetta patients and the labeling was once more changed to reflect more specific information regarding accounts of kidney issues among Byetta users. This series of labeling revisions were meant to allow doctors to make a more comprehensive risk vs. benefit assessment for their patients with Type 2 diabetes prior to prescribing Byetta. The FDA is currently taking a harder look at all those diabetes medicines which belong to a class of drugs known as incretin mimetics. Byetta falls within this class of drugs, and while a Byetta thyroid cancer potential recall is not yet on the horizon, those taking the drug should be aware of the potential dangers. Recent studies point to a two-fold increase in the incidence of thyroid cancer, a three-fold increase in the incidence of pancreatic cancer and a six-fold increase in the incidence of pancreatitis among those taking Byetta. 

Byetta Thyroid Cancer Legal Action

If you or a loved one suffered harm as a result of taking Byetta, it could be beneficial to consult with an experienced Byetta Attorney. You may be entitled to equitable compensation for medical expenses, pain and suffering and lost wages.