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Diabetes Management Safety: The News in 10 Questions or Less

by Reina Natero, University of Florida, PharmD Candidate, 2010

1.    What therapy indicated to improve glycemic control in adults with Type 2 diabetes mellitus is in the news this month?

A small percentage of the total number of patients who have used the drug Byetta (exenatide) are the subject of post-marketing reports that prompted the FDA to approve new revisions to the drug label.

2.    What was reported?

Cases of altered kidney function, including acute renal failure and insufficiency.   To put it in perspective, 78 cases were reported between April 28, 2005 and October 29, 2008, while more than 6.6 million prescriptions for Byetta were dispensed.

3.    How do healthcare professionals benefit from these new revisions?

Healthcare professionals will be better equipped to weigh the known benefits of Byetta with the potential risks that exist for certain patients.

4.    Regarding renal function, what patients should not use Byetta?

 Byetta should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease.

5.    What about patients with moderate renal impairment?

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).

6.    In what ways can the renal function of patients taking Byetta be monitored?

The continued need for Byetta should be evaluated if kidney dysfunction is suspected while using the product.   Monitor patients carefully for signs and symptoms of kidney dysfunction including:

  • Increased serum creatinine
  • Changes in urination (color, frequency, amount)
  • Unexplained swelling in the extremities
  • Increases in blood pressure
  • Lethargy
  • Changes in appetite or digestion
  • Dull ache in the mid to lower back

7.    When should providers consider discontinuation of Byetta?

Consider discontinuation of Byetta if kidney dysfunction cannot be explained by other causes.

8.    What can patients taking Byetta do in light of the new FDA revisions?

Patients should report nausea, vomiting, or dehydration, as these symptoms may contribute to altered kidney function.  Patients should also continue to follow the advice found in the Medication guide at: http://pi.lilly.com/us/byetta-ppi.pdf

9.    Where can both patients and providers find more safety recommendations regarding Byetta and the reports of patients with altered kidney function?

The Food and Drug Administration’s Drug Safety website at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm188656.htm

References

  1. “Byetta (exenatide) and altered kidney function.” Pharmacist’s Letter/Prescriber’s Letter 2009; 25(12):251203.
  2. Information for Healthcare Professionals: Reports of Altered Kidney Function in patients using Exenatide (Marketed as Byetta).” U S Food and Drug Administration Home Page. Web. 25 Nov. 2009.