FDA Alert About Diabetes Medication Byetta Being Linked To Acute Pancreatitis Issued In October 2007
March 2008 FDA Drug Safety Newsletter Article Provided Overview Of Byetta Side Effects Involving Pancreas
Back in October 2007 the FDA issued a MedWatch alert concerning 30 reports of acute pancreatitis in patients taking Byetta (exenatide) which the FDA had received since this diabetes medication was first approved by the agency in April 2005.
The FDA provided some breakdown of those 30 Byetta adverse reaction reports in this October 2007 FDA document, "Information for Healthcare Professionals - Exenatide (marketed as Byetta)", as seen in the following points:
- FDA said there is evidence that suggests an association between Byetta and acute pancreatitis "in some of these cases";
- In six patients the pancreatitis symptoms began or worsened soon after Byetta dose was increased from 5 mcg twice daily to 10 mcg twice daily;
- 22 of the 30 reports indicated that the patients improved after discontinuing exenatide, i.e., "de-challenge";
- Details in three reports indicated that the symptoms of acute pancreatitis returned when exenatide was restarted, i.e., a "re-challenge";
- 21 of the 30 patients were hospitalized;
- Five patients developed serious complications including dehydration and renal failure, suspected ileus, phlegmon, or ascites; and,
- 27 of the 30 patients had at least one other risk factor for acute pancreatitis such as gallstones, severe hypertriglyceridemia, and alcohol use.
At that time, the FDA recommended to patients using Byetta they should seek immediate medical care if they experience any unexplained severe abdominal pain, perhaps accompanied by nausea or vomiting.
Further, as part of this October 2007 FDA warning, the Byetta package insert, or label, was changed to include information about acute pancreatitis in the "Precautions" section.
About five months later, there was an article in the Winter 2008 issue of the FDA's online Drug Safety Newsletter, "Exenatide (marketed as BYETTA): Acute Pancreatitis", which provided some additional information concerning these 30 case reports regarding Byetta and pancreas-related side effects:
- There were no fatalities and no cases describing a hemorrhagic or necrotizing pancreatitis event;
- Nineteen (63%) patients were female;
- The median age of patients described in the case reports was 60 years (range: 43-72 years);
- The median time to onset of symptoms of acute pancreatitis from the start of [Byetta] therapy was 34 days (range: 4-300 days); and,
- A dose-response relationship was observed in six patients who reported the onset or worsening of symptoms associated with acute pancreatitis soon after the dose of [Byetta] was increased from 5 mcg twice daily to 10 mcg twice daily.
Later, there would be a development with regard to the first item in the list immediately above -- which stated in relevant part: "no cases describing a hemorrhagic or necrotizing pancreatitis event" -- when the FDA announced in August 2008 that it had received six cases reports of hemorrhagic pancreatitis or necrotizing pancreatitis in patients using Byetta since October 2007.
More recently, the FDA announced in early November 2009 that there had been 62 cases of acute kidney failure and 16 cases of renal insufficiency in patients using Byetta reported to the agency from April 2005 through October 2008.
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