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FDA Warns Of "Kidney Problems" With BYETTA?

Posted Nov 04 2009 10:01pm

There were 78 reports of "problems with kidney function" in patients taking BYETTA during a 42 month period ending October 2008. Seven million prescriptions for the drug were written during the same time period.

That's one out of every 89,744 prescriptions and it is not specified whether this includes only new, or all, prescriptions.

Two things are interesting here. The first is that the announcement comes 3 days after the drug was approved as stand-alone therapy for Type 2 diabetes. The second is ... how can you prove loss of kidney function in the patients representing the 1 out of 89,744 prescriptionse is solely due to BYETTA. Diabetes itself is the leading cause of kidney failure.

Reuters articledoes not shed any light on that.

A legal website claims the FDA claims "some of those patients already had underlying kidney disease or other factors that put them at increased risk of kidney problems".

How did the FDA sort out which cases were due to BYETTA only?

Once again, the
Attorney At Lawhas no information about this.

Does anyone else have a very puzzled look on their face?

Labels: BYETTA, Incretin Mimetics, Kidney Function, Therapy (Type 2)

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