Amylin Pharmaceuticals, manufacturer of Byetta—a drug used in the treatment of type
2 diabetes—has come under scrutiny as more and more consumers come forward to report
serious side effects from the drug. Pancreatitis and pancreatic cancer as well as
thyroid cancer appear to be potential risks consumers face when taking Byetta. The
manufacturers of the drug, Amylin and Eli Lilly, were partners in the development
and sales of the drug, however in 2011 the two pharmaceutical giants split; Amylin
was given “custody” of Byetta although the agreement gave Lilly a portion of all
future Byetta sales. In 2012, Amylin Pharmaceuticals sold to Bristol-Myers Squib
for $5.3 billion.
Aside from pancreatic issues related to Byetta, a study published by Dr. Peter Butler
in the journal Gastroenterology appeared to establish a link between Byetta and
the onset of thyroid cancer. Further, the GI & Hepatology News—the official newspaper
of the AGA—stated the risk of thyroid cancer was significantly elevated among those
taking exenatide, putting the odds ratio at 4.7 times the rate for a person not
taking the drug. Dr. Butler states that while the analysis of the FDA database does
not definitively establish that thyroid cancer, pancreatic cancer and pancreatitis
are caused by Byetta or other forms of GLP-1 therapy, it does “raise the level of
concern that they may be and that the appropriate prospective studies are required
to rule them out.”
The Byetta FDA Stance has changed somewhat through the years. Byetta first gained
FDA approval on April 28, 2005 then in October, 2007, the first Byetta FDA notice
regarding the drug was issued. This first warning notice came after the FDA reviewed
30 post-market accounts of acute pancreatitis among Byetta patients. Among the 30
patients diagnosed with acute pancreatitis, six experienced symptoms of pancreatitis
soon after their dosage of Byetta was increased.
Twenty-one of the thirty were hospitalized with five developing serious complications.
Twenty-two of the 30 patients improved when Byetta was discontinued with nausea
and vomiting re-occurring in two patients once Byetta was restarted. In the first
notice the FDA cautioned healthcare professionals to instruct those taking Byetta
to see their doctor should they experience any symptoms of pancreatitis such as
serious abdominal pain which doesn’t stop and has no other explanation. The FDA
also ordered Amylin to clearly include data regarding acute pancreatitis on the
drug’s label.
The second FDA Byetta pancreatitis update occurred in August, 2008 in which the
FDA noted receipt of six cases of hemorrhagic or necrotizing pancreatitis among
patients taking Byetta. All six patients were admitted to the hospital for their
symptoms; there were two fatalities and at the time the report was issued the remaining
four were recovering. The four patients who survived were taken off Byetta. The
FDA cautioned those who were experiencing any symptoms of pancreatitis to discontinue
the drug and make an appointment with their physician immediately. Further, the
FDA noted that once a diagnosis of pancreatitis is made, those taking Byetta should
discontinue the drug and another anti-diabetic therapy should be considered. Once
again, the FDA directed Amylin to include clearer more conspicuous warnings on the
label concerning the risk of acute hemorrhagic or necrotizing pancreatitis.
In November, 2009, the FDA once again sanctioned changes to Byetta’s labeling to
include the specific information on accounts of altered function of kidneys, acute
renal failure and insufficiency. From April, 2005 through October, 2008, seventy-eight
cases of renal issues were reported to the FDA among those using Byetta. During
that time frame over six and a half million prescriptions for Byetta were distributed.
These revisions to the labeling of the drug were meant to make it possible for doctors
to conduct a risk vs. benefit assessment prior to prescribing Byetta. The third
round of labeling revisions also included the statement that Byetta should not be
used in patients with impaired kidney function, that physicians should exercise
caution when increasing the dosage of Byetta in those with moderate renal impairment,
and that physicians should closely monitor their patients for any signs of kidney
dysfunction.
Those with diabetes are approximately three times more likely to develop pancreatitis
than the general population, and certain diabetic medications such as Byetta increase
this risk even further. In 2009, the FDA required Amylin Pharmaceuticals to conduct
six post-marketing surveillance studies to investigate the risks of pancreatic cancer
and thyroid cancer among those taking Byetta. This requirement was made because
of the more than 100 reports of thyroid and pancreatic cancer among Byetta patients
prior to 2009.
A recent study reported by Bloomberg linked Byetta to double the risk of pancreatitis
which could change the way doctors treat the more than 25 million Americans with
type 2 diabetes. This study was published on February 25, 2013 in the JAMA Internal
Medicine Journal and noted that pancreatic lesions from Byetta could lead to inflammation
of the pancreas, pancreatitis and pancreatic cancer. Those who have suffered harm
from taking the drug Byetta may have a case and could be eligible for reimbursement
of medical expenses, lost wages, both past and future and pain and suffering. Contact
he attorneys of Sullo & Sullo for a free legal consultation. They can offer you
compassion for your injuries while providing zealous legal representation.