March 2009 Drug Safety Update Newsletter (UK) Raises Emerging Safety Issue Of Kidney-Related Side Effects From Byetta Use
(Posted by Tom Lamb at DrugInjuryWatch.com)
October 2009 Byetta Label Change Follows Earlier Alert From U.K. About Kidney-Related Side Effects
We last reported on Byetta (exenatide) in August 2008, when the FDA issued a MedWatch email alert about six new cases of hemorrhagic pancreatitis and necrotizing pancreatitis that had been reported to FDA since an October 2007 "Dear Doctor" letter about Byetta and acute pancreatitis was sent to doctors in the U.S.
The March 2009 Drug Safety Update newsletter -- from drug regulators in the United Kingdom (UK) -- included this article, "Exenatide (Byetta): risk of severe pancreatitis and renal failure". Therein, we get some new information about two types of serious side effects associated with Byetta, pancreatitis and renal, or kidney, impairment.
We start with the discussion about pancreatitis from this March 2009 Drug Safety Update article about Byetta:
Up to February 2009, we have received six case reports of pancreatitis and a further three cases of acute pancreatitis in the UK.... 396 case reports of pancreatitis have been received worldwide in association with [Byetta (exenatide)] up to September 2008 (mostly from the USA). 80% of these reports were considered to be possibly related to exenatide, and in several cases there was evidence of positive rechallenge. Nine reports of necrotising or haemorrhagic pancreatitis have been received worldwide, two of which had a fatal outcome. After a Europe-wide review, product information for exenatide is being updated to contain further information about this risk.
Strictly Confidential, No Obligation.
We move next to what this article has to say about renal impairment, which may be regarded as an emerging drug-safety issue with Byetta:
Case reports of renal impairment, including several UK reports of renal failure, have
been received in association with exenatide. Up to Jan 30, 2009 we have received seven case reports of acute renal failure in the UK. This medicine is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance <30 mL/min). Clinical experience in patients with
moderate renal impairment is very limited.
Byetta is a diabetes drug co-marketed in the U.S. by Amylin Pharmaceuticals Inc., based in San Diego, and Eli Lilly & Co., of Indianapolis.
We will continue to watch for information about serious adverse reactions in patients using Byetta, especially reports about acute renal failure, or kidney failure, as well as reports of renal impairment causing worsened chronic renal failure.
If you have knowledge about these Byetta side effects that you would like to share, you can do so by submitting a Comment below or contacting me directly.