FDA Working to Revise Prescribing Information for Diabetes Medications

Exenatide Linked to Renal Problems; Sitagliptin Linked to Pancreatitis

By News Staff
11/4/2009

The FDA is revising the prescribing information for the injectable diabetes medication exenatide and the oral diabetes drug sitagliptin phosphate following reports of renal problems associated with exenatide use, as well as reports linking sitagliptin use with pancreatitis.

The prescribing revisions for exenatide, which is manufactured by Amylin Pharmaceuticals Inc. and marketed by Amylin and Eli Lilly and Co. as Byetta, include information on reports of altered kidney function associated with use of the drug.

The FDA said in information it released to physicians that it received 62 reports of acute renal failure and 16 reports of renal insufficiency in patients using exenatide from April 2005 through October 2008. Some cases occurred in patients with pre-existing kidney disease or in those with one or more risk factors for developing kidney problems. Common side effects -- which may have contributed to the development of altered kidney function -- included nausea, vomiting and diarrhea.

The FDA said physicians should not prescribe exenatide for patients with severe renal impairment or end-stage renal disease. The agency also said physicians should

use caution when initiating or increasing doses of exenatide from 5 micrograms to 10 micrograms in patients with moderate renal impairment, and
monitor patients for the development of kidney dysfunction and evaluate the continued need for exenatide if kidney dysfunction is suspected.

According to a Nov. 2 statement from Amylin and Eli Lilly, "The new label expands upon existing language regarding use of BYETTA in patients with renal impairment, which Amylin and Lilly updated in September 2007 to include additional language regarding renal adverse events."

FDA officials also said they are working to revise the prescribing information for the diabetes drug sitagliptin phosphate, which is sold as Januvia, and sitagliptin/metformin, which is sold as Janumet, to include information about reported cases of acute pancreatitis in patients using the products. Merck & Co. Inc. manufactures and markets both medications.

The agency said in information it released to physicians that 88 postmarketing cases of acute pancreatitis were reported between October 16, 2006, and February 9, 2009.

FDA officials are working with the drugs' manufacturer to revise the prescribing information to include

information regarding reports of acute pancreatitis, including hemorrhagic or necrotizing pancreatitis;
recommendations that physicians monitor patients for the development of pancreatitis after initiation or dose increases of either drug and discontinue use of sitagliptin or sitagliptin/metformin if pancreatitis is suspected; and
information noting that sitagliptin has not been studied in patients with a history of pancreatitis.

In a Sept. 25 statement, Merck noted that the company had "voluntarily added pancreatitis to the postmarketing adverse events section of the labeling for JANUVIA and JANUMET earlier this year as a reported adverse event to make physicians aware of these reports."

Adverse events for any medication should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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