Label Changes for Diabetes Drug Linked to Renal Failure

 

 

The Food and Drug Administration has approved label revisions for Byetta (exenatide), a drug used to help control glycemic levels in adults with type 2 diabetes mellitus after almost 80 reports of “altered kidney function” between April 2005 and October 2008. The FDA reports there were 62 cases of acute renal failure and 16 cases of renal insufficiency in patients using Byetta. Some of the cases of altered kidney function were the result of pre-existing kidney disease or other underlying risk factors. However, hospitalization was required in over 90% of the cases and there were four deaths reported.
 

Between April 2005 and September 2008, there were 6.6 million prescriptions for Byetta dispensed by doctors.
 

Patient symptoms include nausea, vomiting, and diarrhea. The symptoms are the most common side effects of taking Byetta and dehydration caused by vomiting and diarrhea may be one of the contributing factors to renal failure in these 78 cases.
 

Byetta Label Changes
 

  • Information about the post-market reports of acute renal failure and insufficiency which highlights Byetta should not be used in patients with severe renal impairment or end-stage renal disease
     
  • Recommendations to doctors and staff to use caution when initiating or increasing doses of Byetta in patients with moderate renal impairment
     
  • Recommendations that patients are carefully monitored for signs of kidney dysfunction and evaluation of the continued need for Byetta if kidney problems are associated while using the medication
     
  • Information added about kidney dysfunction in the patient Medication Guide to help Byetta users understand the associated risks

     

    Users of Byetta should pay close attention to any symptoms they may have, such as changes in urination, swelling in extremities, blood pressure changes, change in appetite or digestion, lethargy, or dull pain in the lower and mid back.