Herbal Spotlight
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 exenatide |
| Byetta |
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Pharmaceutical
company:
Eli Lilly and Company
www.byetta.com |
NEW WARNING
The Food and Drug Administration (FDA) has approved changes to the drug label for exenatide (Byetta) following postmarketing reports of altered kidney function, including renal insufficiency and acute renal failure. Exenatide is prescribed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Some cases of altered kidney function appeared in patients with a history of pre-existing kidney disease, whereas other instances occurred in those with one or more risk factors for developing kidney disease.
The reported cases represent a small percentage of patients who have received the drug. However, the label revisions allow health care professionals to determine whether the potential risks outweigh the benefits to patients. The label revisions include:
- information emphasizing that exenatide shouldn't be used in patients with a creatinine clearance of less than 30 ml/minute
- recommendations to use caution when starting the drug or increasing doses from 5 mcg to 10 mcg in patients with creatinine clearance of 30 to 50 ml/minute
- information about monitoring patients for kidney dysfunction and evaluating whether the drug should be continued if dysfunction is suspected
- information about kidney dysfunction that helps patients understand the benefits and associated risks of therapy.
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