Byetta Side Effects Linked to Reports of Kidney Failure: FDA Warns

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By: AboutLawsuits | Published: November 3rd, 2009

The FDA announced Monday that new labeling information will be added to the diabetes drug Byetta about reports of users who developed kidney failure and other renal problems.

The agency indicates that at least 78 post-marketing reports have linked Byetta side effects to altered kidney function, including 62 reports of kidney failure.

The new labeling warns healthcare professionals to watch for signs of Byetta kidney problems, especially when starting treatment or increasing dosage in patients with moderate pre-existing kidney problems. The FDA indicates that some of the patients who reported Byetta kidney side effects had pre-existing kidney disease or increased risk factors for problems. The new labeling will also highlight that the drug should not be used in patients with severe renal impairment or end-stage kidney disease.

Byetta (exenatide) is a type 2 diabetes drug that is used to control blood sugar levels. It is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels. Byetta is manufactured by Amylin Pharmaceuticals and Eli Lilly & Co. The FDA reports that nearly 7 million prescriptions for Byetta were issued from April 2005 through September 2008.

The FDA indicates that the most common side effects from Byetta include nausea, vomiting and diarrhea, which could be a contributing factor to altered kidney function. Kidney failure on Byetta can lead to a build-up of waste products in the blood, which can result in serious illness or death.

“Health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems,” said Amy Egan, M.D. M.P.H., of the Division of Metabolism and Endocrinology Products at the FDA’s Center for Drug Evaluation and Research. “Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in mid to lower back.”

In October 2007 and August 2008, the FDA issued a safety alerts about reports that linked Byetta side effects to pancreatitis, including severe cases of hemorrhagic pancreatitis and necrotizing pancreatitis, which can be fatal. Symptoms of pancreatitis, which is an inflammation of the pancreas, include nausea, vomiting, severe pain in the upper abdomen and back, a rise or fall in blood pressure, and increased heart or respiratory rates.

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There Are 8 Comments So Far • (Add Your Comments)

  1. i have had a urine infection and my blood sugars have been very high so my doctor has given my byetta with that i have been sick once but just feel sick i cant eat much with this injection i have asked my doctor about his blood results he said your kidneys are fine. So why does it say people with kidney probelms have this byetta. he said it is a good injection it controls blood sugars and you loose your appetite;
    do you think there is some thing wrong because i have has a tempreture for nealy 5 weeks doctor said you will be fine is this write.

  2. I took Byetta in 2005,with good results for my diabetes,however the nausea and upset stomach caused me to return to other methods……After back surgery in 2006, I had Kidney failure ,had to have dialysis..I was very lucky that my kidney funcion returned after a period of time…I would warn anybody ,not to take this dangerous drug at all as it could have been the reason for my kidney failure…I never had kidney trouble before…..

  3. I have had Kidney failure, had to have dialysis many times. There is no reason that my doctors can find that would be the cause of it. UP Till NOW!! Yes it was in 2005 that I started using byetta. These sudden kidney failures are like a gun to my head, I can never tell when or where I will be when my kidneys shut down. I am lucky that my kidney function returns after a period of time. I would warn anybody not to take this dangerous drug at all. As it seems to be the reason for my kidney failure.

  4. I have been a insulin dependent diabetic for 30 years and try to keep up with all of the new drugs etc for Diabetes. I don’t really understand why this medicine Byetta is still prescribed? Alot of people have died from it, so why are the doctors still prescribing it? Why isn’t the FDA pulling it off the market?

  5. My endocronologist just put me on Byetta because my diabetic levels went over 600. I told him I had kidney disease for over 20 years and was in stage 2 but he said this was a good drug and he may keep me on it for the rest of my life if I could tolerate the nausea. After reading the other comments I am getting worried about being on this drug.

  6. I have been on Byetta since 2007. I called it the miracle drug. It helped me loose 60 pounds over three years and my A1C levels are normal. I had some blood test done today and my Creatinine level is 1.7 and my GFR is 34. I looked this up and it could mean stage three kidney disease. This has really made me scared to use this drug.

  7. I am getting worried about taking Byetta, as I have had some kidney problems also.
    What kind of medicine have any of you been placed on to replace the Byetta?
    Just curious as I am getting ready to tell my doctor I am not taking this any more.

  8. Have been taking Byetta for a couple years. It was difficult for my digestive tract to adjust but after a few months it was great. Exercise regularly, have lost some weight and A1c is good. Am well over 65 and have had diabetes 25-30 years. I feel it is a lifesaver.

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