August 2008: Byetta Associated With Hemorrhagic Pancreatitis And Necrotizing Pancreatitis

FDA Has Learned Of Six Such Cases Since October 2007 "Dear Doctor" Letter About Acute Pancreatitis In Patients Taking Byetta

(Posted by Tom Lamb at DrugInjuryWatch.com)

On August 18, 2008 the FDA issued a MedWatch email alert regarding Byetta (exenatide) which informed us that the agency had received reports about six cases of hemorrhagic pancreatitis or necrotizing pancreatitis since October 2007.

As background, the FDA last updated us on the link between pancreatitis and Byetta five months ago, which we covered in a post titled "More Information About Reports Of Byetta Use Being Linked To Acute Pancreatitis":

The quarterly issue of the FDA's online Drug Safety Newsletter [DSN] which was published on March 18, 2008 includes an article about a postmarket safety review of Byetta (Exenatide) that associates this diabetes drug with acute pancreatitis.

As background, one may recall that in October 2007 the FDA issued an alert to doctors informing them that the agency had reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta, which was approved by the FDA on April 28, 2005 to treat adults with type 2 diabetes.

Now, from the "Information for Healthcare Professionals" page for Byetta we get this update from the FDA:

[UPDATED 08/18/2008] Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

For your convenience, we provide these additional resources:

• The January 2008 revised Byetta package insert, or label, for Byetta from Amylin Pharmaceuticals, Inc.; and,

• The October 2007 so-called "Dear Doctor" letter about Byetta from Amylin Pharmaceuticals, Inc. and Eli Lilly and Company.

The October 2007 Byetta Dear Doctor letter was reportedly updated on or about February 27, 2007, but we have been unable to find the revised document on the FDA web site or elsewhere .  If anyone can provide us with a link to that document, or a copy, we will share this with our readers.

Of course, if and when we see any Dear Doctor letter in connection this August 2008 FDA alert about Byetta and hemorrhagic pancreatitis or necrotizing pancreatitis, we will add it to this article.

Comments

[Tom Lamb]

Jason:

I appreciate you sharing your experience with Byetta.

Have any of your doctors associated this condition with your use of Byetta?

You can reply here or, if you prefer, email me directly:
druginjury@gmail.com

Thanks for reading Drug Injury Watch.

Tom Lamb

[Jason Reed]

I took Byetta for about two years. My pancreas quit producing insulin. Now I'm a type one diabetic. A far worse form.

[Tom Lamb]

Patricia:

You can report your pancreatitis as an apparent Byetta side effect to the FDA by submitting a MedWatch report about the matter.

Here are links to some pages at our web site, Drug Injury Law, which will tell you about the FDA's MedWatch program and how to submit a report:

http://www.druginjurylaw.com/drug-injury-reporting.html

http://www.druginjurylaw.com/medwatch-report.html

I suggest that you make a copy of any MedWatch report you may submit for possible future reference.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Patricia]

How is it that the FDA has knowledge of approximately 30 reported cases of pancreatitis? Who reports these cases? I was diagnosed with pancreatitis and taken off of Byetta back in March 08. I don't think the FDA knows about my case. So how many other cases are out there?