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Byetta and Patient Safety

Question from J.A. MOORE:
I have been taking Byette and have a nightly pain which the Dr says is my stomach. I am overweight and have high triglycerides. The Drs ran all kinds of tests on my gall bladder xrays plus other tests....including nuclear meds test. Gall bladder tests turned up negative. Then the Gastro Drs said it must be the valve on the stomach that's weak on diabetics and they gave me some medicine that kept me going to the toliet. I quit the medicine after almost a week of torture. But I took 3-Omega Oils capsules 3 times a day and Liptor and Tricore. My lipids were tested two weeks ago and the pain is gone and my Lipids very low in normal range with one type being under the allowable rate but my Endo Dr said that was OK. SHOULD I WORRY THAT I may have or had pancreatitis? I am still taking the Byette plus Metformin and Lantus..

Answer from Richard Hellman, MD, FACP, FACE:

Dear J.A. Moore,

Your question about Byetta and your nightly pain, which your doctor says is from your stomach, is a very important one, and thank you for asking it. It is not clear as to whether you are free of abdominal pain at this time. If you are pain free at this time, it may be difficult to be sure as to why you had pain in the past. If you are still having nightly pain, then my comments may be more relevant. Since I am not your doctor, I do not know enough about you to make a diagnosis or offer therapy, but I hope I can be helpful in some general suggestions. As we get older, the risk that a pain in the abdomen is a serious medical condition increases. But resistant pain in the abdomen can be from many causes: infections, such as a H.Pylori infection of the stomach, inflammation, such as pancreatitis, or a disease of the intestine called Crohn's disease, motility problems, such as gastroparesis, and other possibilities, vascular problems such as abdominal aneurysms, and also tumors, such as cancers of the stomach and of the pancreas. But there are other, much more common and simple problems, such as irritability of the gastrointestinal tract either due to drugs, such as metformin, or conditions as irritable bowel syndrome. I certainly could not tell from what you have said whether your problem is any of the above, or whether it is or was related to byetta.

But I think your questions are right-on and you should find out why you have had pain and whether it has anything to do with either byetta or to metformin. Your doctor should be able to do some screening tests for pancreatitis, and gastroenterologists can answer other of your questions, but I would encourage you to proceed to ask your health providers to answer your excellent questions.

You should also note that in the editorial I wrote on byetta, I discussed the responsibility of doctors to answer questions of this type. Thank you again for your excellent question. I hope I have been helpful.

Read the Original Article - Byetta and Patient Safety

Leave a Comment

There are 4 comments

paula – california

May 12, 2009 - 18:35

Subject: byette

I have been on byette for over a year. Been doing great but now all of a sudden each time I take it I get so sick to my stomach. Is my body rejecting this med? Have others had this and will it stop it has been a month and I am so tired.

Reply to paula

Dr. Hellman

May 13, 2009 - 16:36

Subject: Dear Paula,

Thank you for your question. It is not the policy of the website to offer any medical advice, but to give general information that we hope will be helpful to you and to others. The person best qualified to tell you what is best for you will be the physician you choose to see. They will need to listen to your history, perform a careful physical examination, and review your previous laboratory and other information and then order any other testing that will be needed to find out what the problem is and what you should do next.

You may find our earlier comments on the patient safety exchange website to be helpful as well and I encourage you to read an editorial I wrote on August 25, 2008 about Byetta, written for physicians, but possibly helpful, and two responses to questions that were in the section of Experts Corner, one from a patient who was having abdominal pain while on byetta with nausea and vomiting, and another from a person who wanted to use byetta in a patient.

Your symptoms are important and should be evaluated soon. Although Byetta has been reported by the FDA to have been found in association with abdominal pain and with nausea and vomiting, it is not at all certain that the Byetta is the cause of your symptoms. It is best not to delay finding the cause of the abdominal symptoms. In general, I recommend that even if the decision is to stop the Byetta (exenatide) on a trial basis that appropriate testing is done to be sure that you have not developed pancreatitis, a problem that had been reported in association with Byetta. Pancreatitis is a very serious medical condition that may continue to be a threat to patients even after the drug is stopped, and should be excluded. But there are other problems that may cause nausea, such as defective emptying of the stomach, or gastroparesis, and others that may have nothing at all to do with the Byetta. I hope that you seek out care to resolve your problem.

I hope this information has been helpful to you and to others.

Sincerely,

Richard Hellman MD
Editor-in-Chief,
AACE Patient Safety Exchange Web Site

Richard Hellman MD – NKC, Mo

August 29, 2008 - 15:46

Subject: Byetta and pancreatitis

Dr Joshi's clear analysis shows the dilemma we face when extensive trials are not done at the front end, and the question we face is whether the one reported case in India of pancreatitis and exenatide reflects the rarity of the condition or the incompleteness of the post-marketing reporting of adverse events. He also lists a series of conditions in which there may be a higher risk of adverse events from exenatide, but it is likely that other important risks factors will be added. Dr Joshi's concern about the LAR preparation of exenatide is also completely logical, but again the problem we face is needing more data than is currently available to assess the relative risk of a preparation that because of its longer duration of action, would potentially be a very attractive addition to the formulary.

Shashank R Joshi

August 27, 2008 - 14:47

Subject: Byetta and Pancreatitis-Emerging Evidence and Practice Issues

Byetta and Pancreatitis - An Indian View
-- Dr. Shashank R Joshi, MD, DM, FACE, FRCP(Glg)
Endocrinologist, Mumbai India
Hon Editor, Journal of The Association of Physicians of India
Chair, Indian Chapter of AACE

Both your bezoar case and pancreatopathy make good reading. Incidentally, I reviewed global literature of all agents of diabetes and their impact on the pancreas. All secretagogues, as well as glinides, have case reports of pancreatitis reported. However, cause-effect relationship has never been proven, both in animal studies as well as reported anecdotes. In fact, the global reportage of pancreatitis is so small statistically that most cases had some other etiology for pancreatic injury. So currently we do not have sufficient evidence for pancreatic injury due to exenatide, but it stands to reason that in a predisposed individual it may act as a potential trigger for pancreatic injury.

The real worry will be the ongoing LAR preparation which is now under phase 3 trial program

Exenatide has some evidence to suggest that it may trigger a cholinergic response in alcoholics and that could be a beeptive pathway for pancreatic injury

So clinically, exenatide needs the following caveats prior to its use:
1) Chronic alcoholics or abuse
2) Refractory GERD
3) History of acute or chronic pancreatitis
4) Gall stones
5) Gastroparesis

One should avoid or exercise caution to use it in the above stated indications. Our institution avoids Byetta in the above mentioned indications till further data will emerge.

In India to date, one case of pancreatitis is reported.