FDA Warns of Additional Byetta Pancreatitis Reports
August 19th, 2008 • Filed Under: News • 10 Comments
On August 18, 2008, the FDA issued an alert to healthcare providers about six additional cases of necrotizing or hemorrhagic pancreatitis among users of Byetta, two of which have resulted in death. The warning follows a prior alert issued by the FDA in October 2007, involving at least 30 other cases that suggested an association between the diabetes drug Byetta and pancreatitis.
Byetta, which is the brand name of exenatide, is a subcutaneous injection administered twice a day to help reduce blood sugar levels in people with type 2 diabetes. It belongs to a class of drugs called incretin mimetics, which mimic the action of endogenous incretin hormones like GIP and GLP-1, which are found in the gastrointestinal tract. These peptides lower blood glucose levels by stimulating insulin secretion from pancreatic cells.
The FDA approved Byetta for treatment of Type 2 diabetes in April 2005, and it has been used by approximately 700,000 people in the United States. It is manufactured and marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co., with annual sales of $636 million last year.
The FDA has recommended that healthcare providers stop their patients from using Byetta if they suspect the development of pancreatitis. If pancreatitis is confirmed or if a patient has a history of pancreatitis, the FDA indicates that another anti-diabetes drug should be used. Also, patients have been urged to report any Byetta side effects, including unexplained severe pain in the abdomen, either with or without vomiting.
Acute, hemorrhagic and necrotizing pancreatitis are very severe forms of pancreatitis, which is an inflammation of the pancreas. Hemorrhagic pancreatitis leads to severe bleeding caused by massive erosion of blood vessels. Necrotizing pancreatitis involves tissue damage, which leads to release of toxins and enzymes into the bloodstream and may cause multi-organ failure and death. None of the severe forms are easily distinguishable from normal pancreatitis.
Out of the most recent reports of 6 cases involving hemorrhagic or necroitzing pancreatitis from a side effect of Byetta, all of the patients were hospitalized for their injuries. Two have died and four were still recovering at the time of the FDA alert.
The FDA indicates that they are working with Amylin Pharmaceuticals, Inc. to develop stronger warnings about the Byetta pancreatitis side effects, which could be placed more prominently on the product’s label.
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Comment by Cheryl on 1 September 2008:
I recently learned of the Byetta lawsuit against Amylin/Eli Lily. I was diagnosed in 2007 of Pancreatitis and pancreatic cancer. I had been prescribed Byetta 2 years ago for my Type 2 Diabetes and have suffered terribly and now with only 1/2 a stomach, 1/2 a pancreas, no duodenum and still having major indigestion, nausea, pain in URQ and back from pancreatitis I feel that Byetta has caused this problem. I do hope there is relief found and this is settled asap. I will forever suffer from pancreatitis and after looking thru my medical records I also suffered from necrotizing pancreas also. Seems I just might have a case here myself.
Comment by Patricia on 14 September 2008:
I was diagnosed with acute pancreatitis in February, after being on Byetta for over one year. I am still suffering with abdominal pain and no Drs. in our area seem to be able to do anything to get my Lipase levels to go down and for the pain to go away. I was taken off the Byetta in March and am seeing Drs. on a weekly basis trying to get some sort of positive results.
Comment by Martha on 22 September 2008:
My husband has been on Byetta for one year. 5Mg seem to have worked well for him, since he’s lost 35 lbs. He doesn’t have any abdominal pain and has no complaints. However, having read recent comments about the probable side effects Byetta is causes, I fear for my husband’s future wellbeing. He’s 70 years old, presently in good shape with his A1G numbers and overall wellbeing. We’ve discussed this with our doctor and are debating on the advantage vs. disadvantage of Byetta.
Comment by Sharon on 22 September 2008:
I was diagnosed with acute pancreatitis in 2007 and almost died. I still have extreme kidney problems and am seeing a nephrologist who believes it is all tied to my usage of Byetta. I also have major indigestion, nausea and pain. I think that the makers of this drug should have to acknowledge those of us that will have to live with the pain that this medicine has caused. I have had no insurance through out this ordeal so I have had to pay out of pocket, and still owe several bills.
Comment by Judy on 4 October 2008:
Hey Cheryl:
My husband took Byetta for a few months in early 2007. He had severe abdominal pain, nausea and started having pain in his right rib cage when he would lie down at night. He was diagnosed with pancreatic cancer in Sept 07. The mass was actually a cyst and the surgeon said he had necrosis. No doctor would believe a medicine could cause this. Since then the warnings have been issued by the FDA. So called experts say Byetta doesn’t cause pancreatic cancer, however, I have seen at least 4 cases on the internet. My husband is doing well on chemo, but the cyst is slighly larger than it was at surgery (it was non-resectable). I pray that your pain will be managable and that you will be heard for the unjustice you have experienced. Thank you for letting others know. Perhaps these post will stop someone decide not to take Byetta.
Comment by sylvia on 29 October 2008:
i was taking 5mcg and my numbers got way better but not good enough so my dr. increased the byetta to the 10mcg and i took it 3 times so far and experienced extreme vomiting along with nausea. i’m going to stop taking it but am worried because this is the only med so far that got my numbers down. i cant handle the way i feel shaky & dizzy from all the vomiting
Pingback by FDA Requires Additional Byetta Safety Data Before Considering Long-Acting Version : AboutLawsuits.com on 5 November 2008:
[...] that they have received reports of at least six cases of severe forms of pancreatitis, known as necrotizing pancreatitis and hemorrhagic pancreatitis, associated with Byetta, including two death. Eli Lilly and Amylin later disclosed that they were aware of at least 4 [...]