The FDA released a press statement Monday, Nov. 2 that it has worked with Amylin Pharmaceuticals, the manufacturer of Byetta,  to add new information to the prescribing information for Byetta to reflect new safety information about kidney problems in people who have used Byetta.

    According to the statement, the FDA has received at least 78 reports of "problems with kidney function in people using Byetta.  Some cases occured in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems."  

     The press release does not explain why it used the word "some" cases occurred in patients with one or more risk factors for developing kidney problems when all diabetics are at risk of developing kidney problems.   It contains advice to Byetta users to "pay close attention to any signs or symptoms of kidney problems."  It does not provide detailed information on the reports to the FDA, which are reported elsewhere.

    The press release is available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188708.htm

      - Paula