Download The Diabetic Medicine Byetta® is possibly linked to Kidney

Byetta®
The Fox Law Firm is Reviewing Potential BYETTA Claims:
The Diabetic Medicine Byetta® is possibly linked to Kidney-Related Side Effects and
Acute Renal Failure
“From April 2005 through October 2008, the FDA received 78 cases of altered kidney function
(62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta®.
Some cases occurred in patients with pre-existing kidney disease or in patients with one or
more risk factors for developing kidney problems ...” -- FDA MedWatch Safety Alert from
November 2, 2009
Byetta® Side-Effects
The following side-effects have been reported in conjunction with use of Byetta®:
• Nausea
• Vomiting
• Diarrhea
These were the most common side effects linked to with Byetta® in clinical trials, and these
side effects may have contributed to the development of altered kidney function in the reported
cases.
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Byetta®
The following side effects have also been potentially attributed to the use of Byetta®:
• Death
• Kidney Dysfunction
• Renal Failure
• Pancreatitis
If Byetta® has been prescribed to you or a loved one and now are diagnosed with renal failure,
altered kidney function, or pancreatitis, please contact us immediately for a free consultation.
Always consult with your doctor before you stop taking any medications, including Byetta®.
Byetta®
Byetta® (exenatide) is manufactured by Amylin Pharmaceuticals Inc, headquartered in San
Diego. This injectable diabetes medicine controls blood sugar levels by helping the pancreas
produce insulin with greater efficiency. Prescribed to treat type 2 diabetes, Byetta® can be used
in combination with other diabetes medicines, and is also approved as an adjunct to diet and
exercise. The drug was prescribed nearly 7 million times between April 2005 and September
2008, the time period of the case studies.
Type 2 Diabetes
In its early stages, Type 2 diabetes can be controlled through diet and exercise. Ninety percent
of all diabetics have Type 2 diabetes, which develops later in life than Type 1 and is often
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Byetta®
associated with excess weight. There are an estimated 200 million people with diabetes
worldwide.
Byetta®, Altered Kidney Function, and Renal Failure
August 2008: the FDA issues a MedWatch alert about six new cases of hemorrhagic and
necrotizing pancreatitis that had been reported to FDA. Pancreatitis is the medical term for
inflammation or infection of the pancreas.
The drug regulation organization in the United Kingdom (UK) published an article titled,
"Exenatide (Byetta): risk of severe pancreatitis and renal failure" in the March 2009 Drug Safety
Update Newsletter. The article discussed two serious side effects potentially associated with
Byetta®, pancreatitis and renal (kidney)impairment.
Then on November 2 the FDA issued a MedWatch Safety Alert, after reports of altered kidney
function in patients using Byetta® increased. Concerned, the FDA approved revisions to the
drug label of Byetta® to warn of the potential risks.
The FDA Labeling changes include:
- Information regarding post-market reports of acute renal failure and insufficiency,
highlighting that Byetta should not be used in patients with severe renal impairment
(creatinine clearance <30 ml/min) or end-stage renal disease.
- Recommendations to healthcare professionals that caution should be applied when
initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate
renal impairment (creatinine clearance 30 to 50 ml/min).
- Recommendations that healthcare professionals monitor patients carefully for the
development of kidney dysfunction, and evaluate the continued need for Byetta if kidney
dysfunction is suspected while using the product.
- Information about kidney dysfunction in the patient Medication Guide to help
patients understand the benefits and potential risks associated with Byetta.
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