The FDA is responding to pancreatitis and kidney failure cases among Byetta users: be sure you are counted
Type 2 diabetes patients who have been prescribed Byetta (technically known as exanatide) need to be aware of potentially fatal health risks related to pancreatitis and renal failure associated with the drug. The FDA has taken formal action, having already required revisions to the patient warnings regarding the risk of kidney/renal failure. They have even issues alerts of their own to healthcare providers and patients. Yet for years since its introduction to the market in 2005, Byetta was prescribed to patients without clarifying all the possible serious health risks-more than 6.6 million prescriptions in its first three-and-a-half years on the market. The FDA now orders physicians to "apply caution" when changing dosages to patients who have used Byetta without previously reporting problems. New information about Byetta users developing life-threatening pancreatitis raises even more questions.
FDA action has been taken; new adverse side effect information is emerging; now is the time to find out about your patient rights
Byetta cases pose a different, more lethal risk than ordinary diabetes-related pancreatitis...and cases are already filed
It may be important for those Byetta patients experiencing pancreatitis to take prompt legal action so that they properly document whether their case shows the distinct type of pancreatitis linked to the drug. The pancreatitis experienced by Byetta patients is called acute hemorrhagic or necrotizing pancreatitis; pancreatic cells are actually destroyed by this disease, as opposed to ordinary pancreatitis where they are only damaged. Hemorrhagic pancreatitis in Byetta users is statistically elevated compared to the percentage among the population at large. Only hospital tests can distinguish one type from the other: you may be entitled to compensation if your pancreatitis is specifically related to your Byetta prescription. More importantly, you may be at severe health risk.
With FDA warnings made public and lawsuits in progress, not taking action now might affect how Byetta users are held responsible for accepting this elevated risk.
Pancreatitis and renal failure cases may have been made worse by Byetta's already known side effects
When Byetta was first approved, its makers, Amylin Pharmaceuticals, Inc. and Eli Lilly & Co., did make known certain side effects. Among the common side effects were nausea, vomiting, and diarrhea. Because these symptoms can lead to dehydration, they are capable of influencing kidney function. In fact, of the Byetta cases brought to the FDA's attention, nearly 20% were in patients who had past medical histories of chronic kidney disease, a percentage the FDA described as "notable." This suggests that the prescribing information provided to doctors and patients by the drug maker was not sufficient to prevent this medically foreseeable negative outcome. The recent emergence of hemorrhagic or necrotic pancreatitis in Type 2 diabetes patients using Byetta, with two deaths already formally attributed to it, may give reason for patients to immediately seek expert help to determine if they have been injured by excessive health risks they were not made aware of.
Byetta warning labels have been changed, but the rights of type 2 diabetes patients haven't. Find out today what your options are!
Type 2 diabetes patients: do you recognize these symptoms?
Symptoms of pancreatitis include:
- persistent, severe abdominal pain without other explanation
- may be accompanied by vomiting, but not in every case
- there are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis from ordinary pancreatitis. Contact a healthcare professional immediately.
Symptoms of altered kidney or renal function include:
- swelling in the extremities without other explanation
- changes in urine color, frequency, or amount of urination
- appetite changes
- changes in blood pressure
- lethargic feeling
- dull ache in mid/lower region of the back
Note: Do not stop or change medicines that have been prescribed without first talking with your healthcare professional.
You have the legal right not to accept exposure to elevated risk of life-threatening medical conditions. Responding promptly may give you greater opportunity to pursue your legal options.
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