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 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.

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.

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.

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.