Byetta Side Effects Lawsuit
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Byetta Side Effects Lawsuit
Byetta Side Effects Lawsuit
According to a report published in the July issue of Gastroenterology and presented at the Lisbon meet of the European Association for the Study of Diabetes on September 14th, type 2 diabetes drug Byetta can put patients at the increased risk of pancreatitis, pancreatic cancer, and thyroid cancer. The study conducted by researchers at the Los Angeles-based Larry L. Hillblom Islet Research Center examined all the Byetta side effect reports that the FDA received between 2004 and 2009 and found that the drug could increase pancreatitis risk by six times and pancreatic cancer by three times compared to other diabetes medications. Researchers also discovered that patients treated with this drug were at a significantly higher risk of developing thyroid cancer.
The FDA approved Byetta, brand name of exenatide, in 2005 for the treatment of type 2 diabetes. Manufactured jointly by Eli Lilly and Amylin Pharmaceuticals, the drug is administered as an injection on the abdomen, thigh, or arm twice a day, 60 minutes prior to the first and last meals. The drug helps pancreas generate insulin and manage blood sugar levels. However, the adverse event reporting system of the FDA also received a number of complaints on hemorrhagic or necrotizing pancreatitis caused by Byetta in 2008. The drug has also been linked to gastrointestinal, neurological, renal, and metabolic side effects.
Byetta FDA Warnings and Complaints
In October 2007, the FDA issued an alert informing consumers about pancreatitis in diabetes patients caused by Byetta side effects. The federal regulator cited 30 reports of severe pancreatitis linked to the drug it had received. The new label changes on the drug reflected pancreatitis warning.
In 2008, the FDA
released information about six more cases of acute pancreatitis, including two deaths. Byetta manufacturers had also received four death reports in the same year. In 2010, a report published in the Endocrine Practice journal highlighted the case of a 64-year-old Ohio woman, who was diagnosed with acute pancreatitis within a month of taking the drug.
In January 2010, the FDA reprimanded Amylin Pharmaceuticals for wrongful promotion of Byetta. The manufacturer presented its drug as a standalone diabetes medication at the annual meet of the Endocrine Society. In March 2010, the FDA warned that Byetta could increase the risk of thyroid cancer in diabetics. The warning was issued after the animal testing of Victoza, a diabetes medication similar to Byetta, exposed possible thyroid cancer links. Amylin admitted that such thyroid cancer risk cannot be ruled out. The regulator also rejected Amylin’s plea to approve Bydureon, a long-duration version of Byetta. The FDA inspectors also identified serious lapses on the quality control and training front at the West Chester Byetta manufacturing plant of Amylin Pharmaceuticals during a routine inspection.
In November 2009, FDA alerted consumers and doctors about possible kidney failure caused by Byetta side effects. The regulator had received more than 80 post-marketing reports of kidney problems, including 62 kidney failure complaints, linked to the drug. The updated label changes on the drug included information about possible kidney function disorders.
In July 2007, researchers at the Tufts-New England Medical Center, Boston, claimed that Byetta was not more effective compared to existing diabetic medications, considering its side effects. The researchers reviewed as many as 29 studies on the drug and its adverse effects.
Byetta Side Effects
Byetta side effects lead to decreased appetite, severe allergic reactions, nausea, weight loss, and persistent headache. Patients taking the drug have been diagnosed with impaired kidney functions, gastrointestinal problems, low blood sugar, persistent stomach pain, and a number of other health problems. The post-marketing reviews have highlighted the following detailed Byetta side effects.
Pancreatitis
Byetta side effects cause acute pancreatitis and other fatal complications. The FDA has received a number of reports of hemorrhagic or necrotizing pancreatitis in patients treated with Byetta. Pancreatitis causes inflammation, bleeding, toxicity, and tissue damage in the pancreas. This leads to discharge of toxins and enzymes into the blood, which has the potential to damage heart, lungs, and kidneys.
Oncologic Side Effects
In some cases, Byetta has been linked to pancreatic and thyroid cancers. Patients using the drug are at three-fold risk of pancreatic cancer. The drug promotes action of peptide 1 hormone in the gut and accelerates insulin secretion from pancreas. Acute pancreatitis caused by the drug results in toxicity and enzyme disorder, which ultimately leads to pancreatic cancer.
Hypersensitive Side Effects
The drug causes hypersensitivity and serious allergy reactions. Patients taking Byetta suffer from injection-site reactions, urticaria, anaphylactic reactions, and itching sensations, including common pruritus.
Gastrointestinal Side Effects
According to postmarketing reviews, users suffer from Byetta gastrointestinal side effects, such as nausea, diarrhea, abdominal pain and dilatation, vomiting, flatulence, and constipation. There have been reports of eructation, dehydration, and flatulence due to the drug side effects.
Other Byetta Side Effects
Nervous system side effects, including somnolence, headache, dizziness, nervousness, jittery, and dysgeusia
Renal side effects, including urinary disorders, impaired renal function, acute renal failure, and kidney transplant dysfunction
Metabolic side effects, including hypoglycemia
Byetta Lawsuit
Amylin and Eli Lilly have been facing a number of Byetta Lawsuit claiming compensation and punitive damages on the ground that the manufacturers have failed to adequately research on the safety aspects of their products and inform consumers about the risks of side effects. On August 19, 2008, a Virginia man sued Amylin and Eli Lilly for their failure to warn about the risk of pancreatitis associated with Byetta. The Byetta lawsuit filed in San Diego Superior Court also alleged that the manufacturers were aware of pancreatitis risk prior to the label changes in 2007. Law firms and attorneys are evaluating a number of Byetta Lawsuit for individuals who had suffered pancreatitis and kidney failure due to the diabetes drug side effects. The $46,000 per plaintiff compensation paid by GlaxoSmithKline to settle 10,000 Avandia Lawsuit in July 2010 and similar Actos Lawsuit against Eli Lilly encouraged many individuals to sue Byetta manufacturers.