Australia's drug regulator has stopped short of compelling increased warnings of kidney-related side effects from an intravenous diabetic drug following revisions in the United States.
The US Food and Drug Administration (FDA) has revised its safety information for Byetta (exenatide) to include new warnings of altered kidney functions, including acute renal failure and renal insufficiency.
The FDA revealed that it had received 78 reports of kidney-related side effects – 62 cases of acute renal failure and 16 cases of renal insufficiency – in patients using Byetta between April 2005 and October 2008.
According to the Therapeutic Goods Administration (TGA), the drug's Australian prescriber and consumer information already carried warnings about renal impairment and failure, including a statement in the precautions section.
"The TGA has had no adverse event reports of kidney impairment, renal failure or any renal or kidney problems associated with Byetta," the TGA said in a statement.
"At this stage the TGA will continue to monitor this issue."
While not listed on the PBS, Byetta is part of the incretin-mimetic class of Type 2 diabetes drugs that have been tipped by a recent Datamonitor report to become the most popular non-insulin antidiabetic medications during the next decade.
A spokeswoman for Byetta maker Eli Lilly said the labelling changes in the US had already been implemented in Australia.
"The warning on severe renal impairment is already a contraindication in the Australian label and the pancreatitis update was finalised here on 1 September, 2008," the spokeswoman said.
Byetta's safety information lists nausea, vomiting, diarrhea, dizziness, headache, jittery feeling and acid stomach as its most common side effects.
It also warns that the risk of getting low blood sugar is higher if Byetta is taken with another medicine that can cause low blood sugar, such as a sulfonylurea.