It is distressing to learn that a medication designed to help Type 2 diabetes patients control their blood sugar may cause potentially deadly side effects. Yet, the U.S. Food and Drug Administration (FDA) has issued warnings that Byetta (exenatide), a Bristol-Myers Squibb product, may be linked to kidney failure and pancreatitis, a pre-cursor to pancreatic cancer.
The lawyers of The Driscoll Firm, LLC, are investigating cases of injury and death among diabetes patients who received Byetta or Bydureon, which is an extended-release form of Byetta.
Below are frequently asked questions (FAQs) we have received:
Byetta is the brand name of exenatide, an injection prescribed along with diet and exercise to help adults with Type 2 diabetes mellitus improve their blood sugar (glucose) levels. Another product, Bydureon, is an extended-release form of exenatide.
Exenatide is among a class of drugs known as “incretin mimetics.” They work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal.
Byetta comes as premeasured doses in an injectable “pen.” It is used twice a day within an hour before eating breakfast and dinner in the evening. Patients start with a dose of 5 micrograms (mcg) twice a day for at least 30 days, but their doctors may increase the dose to 10 mcg.
Byetta is manufactured by Amylin Pharmaceuticals, LLC, which is a subsidiary of the Bristol-Myers Squibb Company. Amylin Pharmaceuticals has its headquarters in San Diego, California.
Amylin Ohio, LLC is a sterile production facility in West Chester, Ohio, which manufactures the global supply of Bydureon.
Bristol-Myers Squibb is a global pharmaceutical and health care products company with headquarters in New York City.
Byetta has been linked to several potentially deadly side effects, including problems that can lead to pancreatic cancer.
Research indicates that the class of drugs known as “incretin mimetics,” which includes exenatide (Byetta and Bydureon) can cause pancreatitis, an inflammation of the pancreas. Pancreatitis can lead to pancreatic cancer, which is almost always fatal, and other maladies.
A Johns Hopkins University School of Medicine study found that the risk of developing pancreatitis doubled in patients who took Byetta or other incretin mimetics. Research also suggests that Byetta increases the risk of pre-cancerous cellular changes called “pancreatic duct metaplasia” in patients with type 2 diabetes, the U.S. Food and Drug Administration (FDA) says.
Even the Byetta website warns that “serious side effects can happen in people who take Byetta, including inflammation of the pancreas (pancreatitis), which may be severe and lead to death.”
In addition, the FDA has reported that it has received dozens of reports of renal failure (kidney failure) in patients who used Byetta. Renal failure, which can be fatal, can be caused by pancreatitis.
Pancreatitis is inflammation in the pancreas. The Mayo Clinic explains that the pancreas is a long, flat gland behind the stomach in the upper abdomen. It produces enzymes that help digestion and hormones that help regulate the way your body processes sugar. Pancreatitis occurs when these enzymes become activated while inside the pancreas, which damages and inflames the organ.
As scar tissue forms, the pancreas begins to function poorly, which leads to digestive problems (and diabetes in those who do not have it already).
Chronic pancreatitis is a risk factor for developing pancreatic cancer, a disease that “often has a poor prognosis, even when diagnosed early,” according to the Mayo Clinic.
Among other complications of pancreatitis are:
- Kidney failure
- Vulnerability to infection
- Pseudocysts (cyst-like pockets in the pancreas)
In August 2008, the FDA said it had received word of six cases of Byetta users developing pancreatitis, including two in which the patient died. The others recovered after hospitalization.
In November 2009, the FDA reported 78 cases of renal (kidney) failure among Byetta patients, and Health Magazine reported in 2011 that two of these patients died. Eighteen cases required dialysis, and two had kidney transplants.
The Johns Hopkins University School of Medicine study released in 2013 suggested that the 100 percent increase in the risk of pancreatitis among Byetta users was based on pancreatic tissue specimens taken from patients after they died from unspecified causes.
No. Byetta and Bydureon are still prescribed and used today.
The FDA has added information about Byetta side effects to the drug’s label and has advised physicians to use caution in increasing Byetta dosages for patients with kidney problems and to monitor kidney function in patients.
The FDA says in its warning about Byetta and pancreatitis that it has not reached any new conclusions about the safety risks posed by exenatide (Byetta and Bydureon) and other incretin mimetic drugs. The agency is continuing to evaluate all available data to further understand this potential safety issue, it says.
The Driscoll Firm, LLC, is investigating cases of pancreatitis, pancreatic cancer, kidney failure and/or other severely adverse side effects among users of Byetta (exenatide).
When a defective pharmaceutical injures a patient who has used it as directed, the injured patient has a right to seek compensation for medical expenses, pain and suffering and other losses through a product liability lawsuit.
Our lawyers can investigate your case and advise you of the legal options available to you. If you are eligible to obtain funds because you or a loved one of yours was hurt by using Byetta, we will pursue all compensation available.
The personal injury and wrongful death lawyers at The Driscoll Firm, LLC, have a successful record of helping clients who have been harmed by dangerous pharmaceuticals and medical devices. We will apply all of our firm’s skills and experience to your case.
The Driscoll Firm, LLC, provides legal assistance on a contingency fee basis. This means clients don’t pay a fee unless and until we obtain money for them.
Our legal team can provide a free initial consultation about your case with no further obligation on your part. If we believe we can obtain compensation through a lawsuit on your behalf, and you choose to pursue such a suit, we still won’t charge you a fee until we obtain a monetary settlement or court-ordered award.
The fee we do charge will be a nominal percentage of the final settlement or award.
Contact The Driscoll Firm, LLC, at our toll-free phone number or through our online form to speak with a Byetta pancreatic cancer attorney.
You may also consult these sources:
- Byetta exenatide injection, Bristol Myers-Squibb
- Bristol-Myers Squibb / Amylin Pharmaceuticals, LLC
- FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes, U.S. Food and Drug Administration
- Safety Alert – Byetta (exenatide), U.S. Food and Drug Administration
- Byetta (exenatide) – Renal Failure, U.S. Food and Drug Administration
- Diabetes drug Byetta tied to kidney problems, says FDA, Health Magazine (via CNN)
- Pancreatitis, the Mayo Clinic