Byetta and Bydureon
Byetta and Bydureon are medicines that contain the drug exenatide. Exenatide imitates the action of a hormone that reduces high blood sugar levels in people with type 2 diabetes.
Exenatide also reduces the hormone that stimulates the liver to make sugar. Exenatide makes a person's blood sugar rise more slowly by slowing down how fast the stomach empties. Because the stomach empties more slowly, exenatide also tends to reduce how much food a person eats.
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.
Who Makes These Drugs?
When Byetta and Bydureon were first introduced, they were made by Amylin Pharmaceuticals and marketed by Eli Lilly and Company. In June of 2012, Bristol-Myers Squibb Co. bought Amylin Pharmaceuticals for about $5.3 billion. A big part of that price was the value of Byetta and Bydureon. Amylin only made one other drug at that time.
Bristol-Meyers Squibb Co. is an American Fortune 500 company. AstraZeneca frequently works with Bristol-Myers Squibb on diabetes treatments. When Bristol-Meyers Squibb bought Amylin, AstraZenica bought the right to develop Amylin's products. AstraZeneca is a British-Swedish multinational company. It is the world's 7th largest pharmaceutical company, measured by 2012 prescription drug sales.
What Are These Drugs 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. People with type 2 diabetes have high blood sugar because their bodies don't produce enough insulin. High blood sugar causes damage to the blood vessels. Blood vessels are everywhere in people's bodies. When blood vessels are damaged, after a while, different parts of the body are damaged.
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. This makes the macula swell, which leads to not seeing well or even going blind.
In the United States, diabetic damage to the retina is the most common reason adults under the age of 75 go blind. Diabetes hurts the nerves - it is called diabetic neuropathy. Neuropathy is feeling weird sensations or not as much feeling in the feet and legs and as time passes, in the hands and fingers. Damage to the nerves and neuropathy also makes muscles weak. Finally, diabetes damages the brain. People are not able to think as well, and have higher rates of dementias, including Alzheimer's.
Why Are These Drugs A Problem?
Byetta was introduced in 2005, and in 2007, the Federal Drug Administration (the FDA) asked that a warning be 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 a patient 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.
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, incretion mimetics, which includes exenatide. The studies show incretion 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.
Incretion mimetic drugs work 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 need to be aware of the signs and symptoms of pancreatitis. They must seek medical attention immediately should they experience any symptoms.
Pancreatitis symptoms are vomiting, fever and nausea. Another symptom of pancreatitis is abdominal pain. Sometimes people with pancreatitis report having a rapid heartbeat. Pancreatitis symptoms can include having swelling and tenderness in one's abdomen. Another symptom of pancreatitis is a change in bowel movements.
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 1 year after diagnosis. Only 5% of people who are diagnosed live 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 bump in the neck near the thyroid. Late symptoms of thyroid cancer are 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:
-medical bills This covers all the costs of treatment, including doctor visits, surgeries, medications, hospital bills, caregiver costs, and checkups after treatment, as well as funeral expenses.
-future medical bills necessary
-lost income Often people being treated for pancreatitis, or pancreatic cancer can't report to work and don't get paid (and possibly lose their job).
-pain and suffering Many people find dealing with pancreatitis, or pancreatic cancer is very painful and disruptive. It can make them very sad and stressed on top of their physical discomfort.
-future loss of expected income
-loss of consortium The surgeries and treatments for pancreatitis and pancreatic cancer are hard on the relationship between spouses.
-punitive damages It is bad for companies to make and sell medicines knowing and hiding the fact that the medicine increased the risk of pancreatitis or pancreatic or thyroid cancer. If the courts find they did, they can be ordered to pay millions of dollars to make an example of them.
I'm Ed Smith, a Sacramento personal injury lawyer since 1982 and member of the Million Dollar Advocates. You can look me up in Yelp or Avvo, or read and listen to testimonials from past clients. If you have taken any of the above drugs and have developed any injury discussed, please call me. I may be able to help you. In Sacramento call 916-921-6400. Elsewhere 800-404-5400.