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
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.
What is the Problem with Byetta?
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.
Is Byetta Safe or is Byetta Dangerous?
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.
What are the Dangers of 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.
What are Byetta Side Effects?
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
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.
Is Byetta Linked to Pancreatic Cancer?
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.
Is Byetta Linked to Thyroid Cancer?
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.
Did Byetta have a Failure to Warn?
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.
Has There Been a Byetta Recall?
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.
Do I Have a Byetta Case and What Do I Do?
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.
What are My Byetta Damages?
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.
How Do I Protect My Byetta Case and Preserve My Right to File My Byetta Claim?
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.
What is the Byetta Statute of Limitations?
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
How likely is a Byetta Settlement?
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.