Information about Byetta
Byetta (Exenatide) is a drug used in the treatment of type 2 diabetes and approved
by the FDA in 2005. Byetta, along with diet and exercise, was supposed to help diabetic
adults control blood sugar levels. Between 2005 and 2009 millions of prescriptions
were written for Byetta, and six reports of death were linked to the drug. A study
published in Gastroenterology stated that more than 1,000 Byetta patients have been
diagnosed with pancreatitis while at least 375 patients have been diagnosed with
pancreatic cancer or thyroid cancer. Byetta is generally injected twice a day, before
breakfast and before dinner. It is believed that Exenatide contains a synthetic
form of a hormone which occurs naturally in the saliva of Gila monster lizards.
This synthesized hormone is fifty percent identical to the body’s natural hormone,
GLP-1, found in the digestive tract.
Byetta and the FDA
Byetta was originally manufactured by Amylin Pharmaceuticals and Eli Lilly Company.
These two pharmaceutical companies split in 2011, then in August of 2012 Amylin
sold its company which included Byetta, to Bristol Myers-Squibb for $5.3 billion.
The FDA issued a notice regarding Byetta to consumers and physicians a mere two
years after its approval. After receiving post-marketing data regarding thirty Byetta
patients who developed acute pancreatitis, the FDA required sterner warnings on
the label of Byetta. Among those thirty patients, six began experiencing pancreatitis
symptoms soon after their doctor increased their dosage from 5 mcg to 10 mcg.
In 2008, the FDA once again required an updated warning label from Amylin regarding
Byetta after receiving evidence of six cases of acute pancreatitis among Byetta
patients. These six patients were all admitted to the hospital, and two died from
necrotizing pancreatitis. The new warning label asked that patients taking Byetta
to discontinue the drug should they experience any symptoms of pancreatitis and
see their physician immediately. The labels further stated that those who have received
a diagnosis of pancreatitis should consider taking a different anti-diabetic drug.
Once more in November, 2009, Amylin was required to update Byetta’s labeling to
include very specific information on potentially altered kidney function, renal
failure and renal insufficiency after seventy-eight cases of renal issues were reported
from those taking Byetta. The revisions mandated for Byetta labeling was meant to
give doctors the opportunity to determine risk vs. benefit prior to prescribing
Byetta to their patients.
Potential Byetta Lawsuits
Patient allegations in the already-filed Byetta lawsuits state a failure to warn
on the part of the Byetta manufacturer about the possible serious side effects associated
with the drug. The manufacturer of Byetta never mentioned the risk of pancreatic
cancer, leaving many wondering if financial greed motivated this omission. Byetta
lawsuit attorneys will claim there was also a failure on the part of the Byetta
manufacturer to advise health care professionals regarding the importance of keeping
a close watch on Byetta patients for early changes in the pancreas.
It is expected that each Byetta pancreatic cancer lawsuit will allege a failure
to test Byetta sufficiently prior to introducing the drug. In fact, only one small
clinical trial involving short-term treatment was undertaken prior to marketing.
Finally, Byetta attorneys may claim that the manufacturer of Byetta failed to instigate
a recall even after it was clear the risks might outweigh the benefits when compared
to safer alternatives. Victims of Byetta who believe they were harmed by the drug
should consult with a knowledgeable Sullo & Sullo attorney as soon as possible in
order to establish whether they have a valid case and are entitled to compensation
for their injuries.
Factors Which Determine Your Right to File a Byetta Pancreatic Cancer Lawsuit
The attorneys at the Law Firm of Sullo & Sullo will always thoroughly evaluate your
case, taking into consideration your individual circumstances and the harm you suffered
as a result of taking Byetta. If we determine it is in your best interests to file
a lawsuit against the manufacturer of Byetta we will take care to explain everything
you will need to know about your case. If you have not yet suffered any ill-effects
from Byetta—or only minor side effects—our attorneys will likely advise you to continue
to monitor your health closely and to contact us should your doctor discover any
signs of pancreatitis, pancreatic cancer, thyroid cancer or renal problems. Those
who took Byetta, believing it to be perfectly safe who developed serious medical
issues may be eligible for all medical expenses which resulted from taking Byetta
as well as lost wages pain and suffering. If you have suffered serious harm after
taking Byetta, you could benefit from the zealous representation offered by the
attorneys of Sullo & Sullo.
Factors Which Determine Your Right to File a Byetta Thyroid Cancer Lawsuit
Because recent studies have linked Byetta with thyroid cancer as well as pancreatic
cancer, it is expected that thyroid cancer lawsuits will begin being filed as well.
Byetta thyroid cancer is rarely life-threatening however there is always the chance
the thyroid cancer could spread to other parts of the body such as the lungs or
bones. Symptoms of Byetta thyroid cancer include a chronic cough, swallowing difficulty,
a lump or enlargement of the thyroid gland, swelling of the neck and a hoarse voice
that does not go away. In some cases the entire thyroid must be removed with the
success of the procedure being dependent on a variety of factors such as the age
of the patient, the type of thyroid cancer, the stage of the cancer and the overall
health. Those who took Byetta and developed thyroid cancer could find the help they
need from speaking to a Sullo & Sullo attorney.
While there have been Byetta diabetes drug lawsuits filed, as of this time there
are no Byetta mass tort actions or MDLs in the works. Januvia, a type 2 diabetes
drug which has also been found to carry a significant risk of causing pancreatitis
or pancreatic cancer among users has a bellwether trial slated for this summer as
well as one MDL in place and a motion for another. An MDL or mass tort lawsuit allows
sharing of resources; while there is a team of common representation for the plaintiffs,
the plaintiffs remain individualized. Contrary to a class action suit, this means
that those who suffered more harm from Byetta can potentially receive larger settlements
should the jury find in their favor while Byetta users who suffered less harm may
receive lesser settlements. It is very likely that we will be hearing about mass
torts and MDLs regarding Byetta in the near future.
Our Sullo & Sullo pancreatic cancer lawyers are highly experienced and have the
necessary background and knowledge of drug liability cases to ensure their clients
are totally protected. Our firm keeps the focus firmly on our clients and we want
to help you get your life and your future back and will fight hard for your rights.
Contact Sullo & Sullo today for the help you deserve.