Byetta and Bydureon
Byetta and Bydureon are inject-able medicines. Exenatide drugs are not used to treat type 1 diabetes. Medicines containing exenatide have not been proven safe for pregnant or breastfeeding women, or children. Byetta was first approved by the FDA in April of 2005. It is injected twice a day. From its introduction until September of 2008, more than 6.6 million prescriptions for Byetta were dispensed. By 2012, sales of Byetta brought in more than $517 million. In 2010, a long-acting version of Byetta was introduced under the name Bydureon. Bydureon is injected once a week.What Are Byetta and Bydureon Used For?
Both Byetta and Bydureon treat type 2 diabetes. Other drugs used in Type 2 Diabetes are Januvia, Janumet, Victoza. In type 2 diabetes, a person's body becomes less sensitive to insulin. In the body, insulin breaks down glucose, a type of sugar. Broken down glucose is either stored in the body or used for energy. Normally, when people eat, their body senses the need to make insulin. When a person's body doesn't respond well to insulin, over time, their body stops making enough insulin.Damages From Diabetes
Diabetes can hurt the heart muscle. This leads to heart failure. Diabetes also hurts the kidneys. When kidneys don't work well, that is called renal failure. People with renal failure have to go on dialysis to stay alive. Diabetes is the biggest cause of kidney failure in the developed world. People with diabetes can get damage to their eyes. New blood vessels that grow in the retina aren't as good.
The following YouTube video explains the symptoms of nerve damage from diabetes.Why Are These Drugs A Problem?
Byetta was introduced in 2005, and in 2007, the Federal Drug Administration (FDA) asked that a warning is added to the label. The warning told doctors and consumers that there were reports of people developing acute pancreatitis while taking Byetta. In August of 2008, the FDA reported more cases of people taking Byetta and getting even worse forms of pancreatitis than before. Two of those patients died. The FDA urged doctors to use other medications for patients with a history of pancreatitis.
If patients on Byetta got pancreatitis, they should stop taking it immediately. In 2009, the FDA issued a safety update about Byetta and pancreatitis. The FDA acknowledged a possible connection between Byetta and the risk of pancreatic and thyroid cancer. Thyroid cancer is treatable and far less deadly than pancreatic cancer.Incretin Mimetics
Bydureon wasn't involved in these early reports and updates because it was not introduced until 2010. In 2013, the FDA announced it reviewing unpublished studies on an entire class of drugs, incretin mimetics, which includes exenatide. The studies show incretin mimetics increase the risk of pancreatitis and pancreatic cancer.
Basically, in response to eating, the body makes a hormone that signals the pancreas to make insulin. The body also makes an enzyme that breaks down that hormone, eventually stopping the signal to make more insulin. Incretin mimetic drugs work in two ways. Some, like Byetta and Bydureon, add an artificial hormone that increases the body's insulin production. Others add a drug that blocks the enzyme that breaks down that hormone, so the body's natural hormone signaling the body to, "make more insulin," lasts longer.What Is Pancreatitis?
Pancreatitis is when the pancreas gets swollen and painful. Having pancreatitis, over time, can lead to pancreatic cancer. People taking Byetta and Bydureon should know the symptoms of pancreatitis. Seek medical care immediately if you experience any of the symptoms.What Is Pancreatic Cancer?
Pancreatic cancer one of the deadliest types of cancer. Only 25% of the people who are diagnosed with pancreatic cancer live one year after diagnosis. Only 5% of people who are diagnosed live for 5 years. Pancreatic cancer is the 4th most common cause of cancer deaths in the United States.
Pancreatic cancer is rarely diagnosed in people under 40. Pancreatic cancer symptoms are having pain in the back or upper abdomen, sometimes spreading from the stomach to the back.
Another symptom is jaundice, where the whites of the eyes and/or the skin turns yellow. People with pancreatic cancer often have unexplained weight loss, either from losing their appetite or because they aren't digesting their food normally. Another symptom of pancreatic cancer is indigestion or heartburn.What Is Thyroid Cancer?
Thyroid cancer is a very treatable form of cancer in the cells of the thyroid. It is usually treated by surgery taking out the thyroid and radiation. In the United States, 97.8% of people diagnosed with thyroid cancer and treated live at least 5 more years. An early sign of thyroid cancer is enlarged lymph nodes. Another early sign of thyroid cancer is finding a lump in the neck near the thyroid. Late symptoms of thyroid cancer are a pain in the back of the neck and changes in the voice.Do I have a Right to Recover If I Develop Pancreatic Cancer?
There is a good likelihood you do. Many people who took these medicines and other drugs in this class and later developed pancreatitis, or pancreatic cancer or thyroid cancer have sued. So many lawsuits have been filed across the country that the cases have been bundled into federal multi-district litigation. The federal suits are being heard by federal Judge Anthony Battaglia in San Diego. Some people who took Byetta, Bydureon, or other diabetes drugs in this class filed lawsuits in California state courts.
These cases have been brought together in a "judicially coordinated" proceeding in Los Angeles. These cases are being administered under state court Judge William Highberger. The original maker, Amylin Pharmaceuticals and the original marketer, Eli Lilly, and Company, can both be held liable. Bristol-Meyers Squibb and AstraZeneca are also possible defendants because of their 2012 purchases of the rights to manufacture and market the medicines.What Damages Can I Recover?
A typical lawsuit by a person who has gotten pancreatitis or pancreatic cancer after taking these medicines asks for money to pay them back for:
- Current and future medical expenses
- Current and future loss of income
- Loss of Consortium
- Pain and Suffering
- Punitive Damages
I'm Ed Smith, a Sacramento Drug Products Liability Attorney. If you are experiencing side effects after taking Byetta, reach out to me today for free, friendly legal advice at 916.921.6400, 800.404.5400.
Editor’s Note: This page has been updated for accuracy and relevancy [cha 5.8.20]
Photos by PDPics on pixabay, Myriams-Fotos on pixabay