Diabetes Self-Management Blog

The injected Type 2 diabetes drug exenatide (brand name Byetta) has been in the news this week because of safety concerns. The U.S. Food and Drug Administration (FDA) announced on August 18 that six cases of severe pancreatitis have been reported in people taking Byetta since October 2007.

Last October, the FDA issued an alert that 30 cases of acute pancreatitis in people taking Byetta had been reported; you can read more about that news in Jan Chait’s blog entry “Byetta Garners Pancreatitis Warning.” At that point, manufacturer Amylin Pharmaceuticals, Inc., agreed to add information about pancreatitis to the “precautions” section of Byetta’s label.

However, since cases have continued to be reported, the FDA stated this week that it is now working with Amylin on another labeling revision “to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.”

In the six most recent cases, all of the people with pancreatitis were hospitalized, and two died. One person who developed pancreatitis while taking Byetta filed a personal injury lawsuit against Amylin this week, alleging that the manufacturer did not adequately test and monitor Byetta’s side effects or warn doctors and people taking Byetta of pancreatitis risk.

The FDA is reminding people who take Byetta to seek medical attention immediately if they have signs of pancreatitis: severe, unexplained abdominal pain, which may or may not be accompanied by nausea and vomiting.

While the prospect of developing pancreatitis is frightening, it is also important to remember that 36 cases of pancreatitis have been reported to the FDA while more than 700,000 people around the world have taken Byetta. In other words, these cases represent about five thousandths of one percent of people who have taken Byetta.

You can learn more about how Byetta works in the article “Exenatide and Pramlintide: New Meds on the Block.”

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Comments
  1. Thanks for the reminder. Many physicians have not yet committed this association - Byetta and pancreatitis - to memory. Some physicians will need their patients to remind them. I am a hospitalist and see one case of pancreatitis every two weeks.

    -Steve

    Posted by Steve Parker, M.D. |
  2. I was just put on Byetta and wow it has given me the best control over my Diabetes Type 2 since I was diagnosed in 1992. I have not had any of the symptoms associated with Byetta but I was concerned when I saw the report on TV. I spoke with my doctor and he didn’t seem concerned in the least and said to continue on my Byetta. Of course, if I should experience any abdominal pain to stop the medication immediately and contact him.

    Posted by luvmy3toys |
  3. Last year my doctor tried me on byetta for three months. 15 minutes after I took it, I became anuseated and started vomiting. I lost 30 pounds in those months and my blood sugar was low because I was becoming bolemic. I couldn’t keep a thing down.

    Posted by S Riffey |
  4. My Doctor, when quized, indicated that of those patients having problems with Byetta most had a prior condition involving the pancreas. So what specifics are known about this?

    My expderience is that I lost 20 pounds in about 3 months, but not without nausia at the beginning. My tolerance seems to be not more than 5 units at the 9 month point. My sense is that further increases could be problematic especially given the reports prompting this concern. With only one pancreas we need facts even though the per centage of issues is low.

    Posted by Bob |
  5. This is the 1st time I have heard about the side effects of taking Byetta. I have been on Byetta since 2006-2007 up until last Thursday I haven’t had any side effects. But I did spend last Thursday through Sunday in the hospital with diverticulitis. I think on that note I will stop taking the Byetta.

    Posted by Debbie |
  6. Hi Debbie,

    Please make sure to discuss your treatment with your health-care provider before you make any changes; don’t just stop taking Byetta or any other drug on your own.

    Posted by Tara Dairman, Web Editor |
  7. I have had 3 times when I have bad pain in my stomach. I vomited once each time. It happened about 3 weeks apart. What are the symtons to be concerned about pancreatitis.

    Posted by heleng |
  8. Hi heleng,

    You may want to read more about pancreatitis symptoms here. While nausea and vomiting can be side effects of Byetta, severe and persistent abdominal pain is not and may be the sign of something more serious. I’d suggest you contact to your doctor about your symptoms.

    Posted by Tara Dairman, Web Editor |
  9. I’ve been on Byetta 10 mcg now for about 2 years, My lifestyle recently changed within the past 3 months where I’m commuting less and eating earlier at dinner. Since I’ve moved, I have terrible bouts with indigestion, nausea, and sometimes short dry heaves. It started mostly in the morning and now it’s almost all day. I have nausea meds to make it go away for awhile. I have found myself taking only the shot in the morning and using my metformin in the eve, but I know it’s not working as well. Time to get to a new endocrinologist and get on Lantus for better control.

    Posted by tbluett |
  10. I took Byetta for about three or four months and lost weight, which I liked, but I had constant stomach pain and diahhrea…..my doctor took me off of it. I liked it because I lost weight, but then I ate less because my stomache hurt so much……

    Posted by sanfordsue@sbcglobal.net |
  11. I developed pancreatitis two years ago and feel that Byetta was the cause.

    Posted by Tubick |
  12. I was on Byetta for about 8 mos, about a year ago. I was nauseaed and vomited a couple of times the first couple of days I took it and then it resolved. I had an itchy rash for about a month after that. It finally resolved. I stuck with it, because it kept my blood sugars down, lowered my A1C and I was able to lose about 15 lbs. Now, after being off Byetta for about a year, due to the pancreatitis scare, I started having severe upper abd pain going through to my back with nausea, bloating and vomiting. I thought it might be my gallbladder, but when I saw another article about Byetta was wondering if there could be a link. Has anyone heard of this type of reaction happening after being off of Byetta for a while?

    Posted by anne08 |
  13. My Dr. prescribed Byetta and Symlinpen - both injectables. Within two days I started getting a rash that turned into painful and itchy sores in my hair on the top of my head. I quit using both meds. due to the allergic reaction.

    Posted by leandrab |
  14. I was on Byetta in 2007 and didn’t lose any weight at all. I had low level nausea nearly the whole time. I stopped the Byetta and my doctor changed me to Humulin at night–maybe the pancreas was trying to tell me something! I have had pancreatitis before and it is absolutely NO FUN. The symptoms: unrelenting nausea and vomiting, back pain and abdominal pain, extreme fatigue.
    We all know our bodies better than anyone else, it is up to us to watch ourselves and notice the side effects.

    Posted by nana |
  15. I have had pancreatitis where my stomach was pumped for 3 days and I was in the hospital for 24 days. Even if one person got pancreatitis while using this drug, that is too many. Pancreatitis is excrutiatingly painful and I was in critical condition during the first week. I thank God that I survived. So please do not highlight statistics that minimalize the number, one’s life is just to precious.

    Posted by Shirl B |
  16. I took Byetta for over 8 months, had nausea
    ,lost a few pounds had fairly good blood sugarreadings but since I have had a severe bout of pancreatitis in the past I decided not to chance it, so I quit the Byetta on endo’s
    orders. Tried Symlin but that didn’t work
    at all for me (I’m type 2 )so I’m just
    taking humalog before meals and Levemir
    (can’t take Lantus due to an allergic
    reaction to it). My numbers are higher
    than I like but working on that. Very insulin
    resistant (PCOS that wasn’t diagnosed or
    treated properly years ago).

    Posted by Missourimom |
  17. I was on Byetta for several months and every time I took the shots; I thought that I was going to died. I had lots of pain and I became bulimic. I stop I could not take the medication any longer. Please do more research on side efects.

    Posted by Rose |
  18. My daughter was put on Byetta and had so much nausea, she threw up her dinner every night. Some times it would be so bad she would go to bed & try to sleep through the nausea. Not always successfully.
    True she has lost weight, but then she isn’t eating that much anymore.
    She continues to take the Byetta, and will still have bouts of nausea, but doesn’t vomit as much.
    Being a type 2 diabetic myself, there’s no one that could convince me to take it.
    I take Nonalin & Novolog.

    Posted by Raccary |
  19. I have had NIDDM for 12 years now. I currently take glucophage for control of my blood sugar. My hemogloboin A1C runs about 6.0, which is in the normal range. For some unknown reason, my MD wanted to start me on Byetta approx. 1 year ago. At that time my blood sugars were running between 75 - 110mg/dl. I respectfully told him that I would not take Byetta because my DM was controlled on the glucophage. He told me that it would probably help me to lose weight. I still said no. Thank God that I did. Always be cautious of trying new medications. Often times they are not researched enough prior to being put on the market. Also, be informed and take an active part in your own health care. I always request copies of my lab test results and go over them thoroughly. Be in the know.

    Posted by Miss J |
  20. My brother passed away 4 years with pancreatic cancer. No way, would I start taking a medicine that remotely cause changes in my prancrea.

    Posted by Nora Miller |
  21. My husband was put on Byetta for almost a year without his diabetis dr. ever telling him of the risk of pancreatitis. HELLLOOOOO.
    When are doctors going to stop being bought off by these pharmacutical companies???

    Posted by Sophia |
  22. I was on Byetta for 2 years and never had any nausea or vomiting or abdominal pain. I am type 1 but together with my insulin therapy, the Byetta helped tremendously. I recently had to switch endos, and the new one took me off Byetta. My numbers have doubled and I am not a happy camper. Regardless of this pancreatitis issue, I would go back on it in a heartbeat if I could.

    Posted by Trav |
  23. I took Byette for only a few days and took myself off of it, as I started having very bad discomfort of the stomack, looks like I done a good thing, of course called the Dr. and told him and he agreed with me.

    Lois Koppel

    Posted by Lois Koppel |
  24. I have been taking Byetta for 8 months and have seen a 30 pound reduction in my weight. Kudos to the developers of this medication. For me the loss of weight is more important than the fear of pancreatitis.

    Posted by Bill Smith |
  25. I took Byetta fro two years and lost 70 pounds then with still 100 pounds left to loose I started having kidney problems. I switched to actos with glucovance and subsequently puit fifteen pounds back on 9 months after stopping the Byetta.

    Posted by Harry.............................. |
  26. i have been on byetta for 3 months. i feel better on it but i am scared too for i lost my brother to panceratic cancer a 1year and a half ago. what do you do when you have so many mixed feelings. my doctor told me to stay on it. who do you listen to?

    Posted by belinda |
  27. The first time that I went on Byetta, I went off of it within a few months because I kept hearing that persons I knew were throwing up.

    Last fall the endocrinologist was going to put me on Insulin–I requested that we try Byetta again. In addition I also take 750mg of Metformin Ext. Release. Since Sept. 07 I have lost a total of 36 lbs. At a Diabetic Cooking School last week my Hemoglobin A1c was tested. At this time I have dropped from 7.4 to 5.6. My blood sugar average is 127 over a three week period. The only difference that I can definitely recognize is in taste. There are items that I used to enjoy eating, but now they don’t taste right.

    It is my prayer that I continue to remain in the majority of persons who are doing well. This is the first time that I have been near 200 lbs in probably twenty years.

    Posted by Gloria Penn |
  28. To me Byetta was am answer to my prayers.Took off 91 lbs. slowly but constantly. Started by barely being able to walk two blocks went on to over two miles. Now go to the gym and walk 45 minutes on the treadmill. Absolutely no side affects -loved the loss of appetite for the first year. I fought taking insulin for a long time –now on insulin (I HATE IT) SO I HAD TO STOP
    BYETTA—really dislike the constant hunger. Best friend in California on Byetta sugar stays at 5.4.

    Posted by turtle taxon |
  29. I took Byetta for a week and was so sick to my stomach. I vomited all day and night too. I tried to eat but it wouldn’t stay down. I spent a week in bed.I stopped taking it after that. Never again!!!!

    Posted by Joymac |
  30. Let’s all take a moment to see the whole picture about Byetta.

    Yes, there is a slight risk — this is NOT minimizing that risk, but being factual, since 36 people in over 700,000 is a quite small percentage — of developing pancreatitis if you use Byetta. Using Penicillin or any other antibiotic has a much higher risk factor and rate of death than this.

    And, yes, pancreatitis is a serious condition.

    And, yes, it’s probably wise for anyone with any kind of previous pancreatitis problems to not take Byetta.

    The bottom line is that nobody knows how their body will react to any medication. No matter how slight the risk might be, there is always a risk with any medication. Or even “natural” products, such as herbs or supplements. This is true of the ones we might take for cholesterol, blood pressure, heart problems, arthritis, etc. Even plain old aspirin and other meds in its class can cause kidney failure.

    Very importantly, we do need to realize that the popular press grabs onto ANY sort of medical news and dramatizes and distorts it. Who would pay attention to their articles if their irresponsible practices didn’t make things “exciting?” Remember to consider the source when reading the daily paper or popular magazine — take their medical info with a grain of salt. That’s not saying that pharmaceutical sources should be considered gospel, either. Take theirs with two grains of salt. Go to a research site such as PubMed and check things out.

    A specific and important detail in this news about Byetta is that most of the people who developed the problem did so after switching from 5 micrograms to the 10 microgram dosage. Would this, then, suggest that anyone taking any dosage at all quit taking it, let alone quit taking it without talking to their doctor first?

    I could hardly wait for Byetta to be put on the market, because I’d been reading about its development. I had good control by “being good” and also using Metformin — now, are you all familiar with the risks of taking that med, right? — those risks were dramatized by the press just a couple of years ago — my A1c’s reading in the 5 to 6 range. My doctor was reluctant to switch me because why fix something that isn’t broken.

    About three months after Byetta was available to the public, I was bitten by a pitbull and put on Augmentin — a standard antibiotic for dog bites — which led me to have horrendous yeast infections and blood sugars that were alarmingly high. After being off the Augmentin for a month, I was still having problems with my blood sugar. My A1c went up to 9.4! My doctor was alarmed, too, and put me on 5mcg of Byetta immediately.

    Yes, it made me a bit queasy for a week or so, and I was lucky and grateful to have such a mild reaction. But, when after only two months, my A1c came back at 6.3, that discomfort was well worth it. The next one came back at 5.2, and since that time, my A1c has been in the 5.0 to 5.5 range.

    After a year or so of taking Byetta, my doctor asked if I’d like to try the 10mcg dose to see if it would help with weight loss, since the 5mcg dose hadn’t changed it.

    I’ve been taking 10mcg for over a year — again had the mild nausea for a couple of weeks while my body adjusted — and have lost about 40 pounds. I attribute this to the fact that this dose of Byetta seems to reduce my appetite — I get full a lot sooner.

    So, to me, in my case alone, since I’ve had no real problem with Byetta — and since I am aware of the symptoms of pancreatitis and would rush to the doctor if I had them — it seems to me like a miracle drug. Unless something untoward happens with it — or they discover an actual cure for type 2 — I’ll never give it up.

    In fact, I can hardly wait for the once-a-week form to be released for prescription.

    Posted by marcie |
  31. I started byetta 8 months ago. My sugar is great,I have dropped weightand I have more energy but I don’t want to be sick. Should I see my doctor?

    Posted by lyndat |
  32. I started with 5 mg and went to 10 mg - twice a day - for hours I had nausea and was unable to do anything - at this point in time I have stopped taking Byetta until I can get into my doctor’s again - I tried this for several months and still have the same result.

    Posted by Jim |
  33. I started with 5 mg and went to 10 mg - twice a day - for hours I had nausea and was unable to do anything - at this point in time I have stopped taking Byetta until I can get into my doctor’s again - I tried this for several months and still have the same result.

    Posted by Jim |
  34. I have been on Byetta since July 3, 2007. I have had no adverse reactions. My A1c umber has gone down to 6.8. I amsatisfied so far James

    Posted by James |
  35. Hi lyndat,

    If you think you may have symptoms of pancreatitis or can’t tolerate the side effects of Byetta, talk to your doctor. But if it seems to be working well for you, keeping up with your regular routine should be fine.

    Posted by Tara Dairman, Web Editor |
  36. The statistics ahve been skewed to mislead here. The FDA only collects data in the United States, so comparing that number with worldwide takers of this medication is not valid, and also, only a few of many people ever report side effects to the FDA. This is only the tip of the iceberg.

    Posted by makinamotze |
  37. Byetta kept my blood sugar too low all the time, and I was miserable the entire time I was on it. I was constantly treating lows. One night it got to the point where the more sugar I ate the lower my blood sugar went. It took 80 grams of carb to raise my blood sugar 15 points out of the danger area.

    Posted by alvee chipmunk |
  38. I have been taking Byetta for 2 months. I
    had some nausea on the 5 mg. Now, I am on
    the 10 mg, and I am sick all the time. I
    cannot eat well when I take it. Yet, I want
    to try to take it. My blood sugar runs
    between 110 and 170 fasting. I take 2 shots
    a day. I am having low blood sugar at night.
    How long does it usually take to get used to
    the 10 mg?

    Posted by specialmom |
  39. Prior to Hurricane Katrina, I was on Byetta, and had to stop due to the storm and no power. I had nausea and diarrhea most of the day. I was also on Fortamet with the same side effects. Can’t take metformin as sick all day and night from it. I went on Januvia-after a few months of numbers going up–tried Byetta again. When I am nauseated, I try mint tea and an accupressure wrist band for sea sickness. It works. I don’t eat as large an amount of food and watch what I eat–such as very little fried(Louisiana), very little if any fat products (salad dressing, even very little butter substitute toast, etc). This has helped. I now eat smaller meals, more often thru the day and that had helped decrease or almost eliminate the intestinal problems. After all, we are not gila monsterseating once a year with a protein/enzyme to control our digestive tracts. As a diabetic I do a lot of research and am an extremely active component of my diabetic team. I don’t wait for my doctors to tell me about side effects or risks. I do my own research. I then go to the rest of the team or doctor and ask questions.

    Posted by Mary Lou |
  40. I’d be afraid of the consequences of not taking
    Byetta, more than the little symptoms it causes.

    It has done wonders for me, 40lbs lighter and
    blood sugars are a boringly flat 120 in the morn.

    You’re probably in more jeopardy driving to the
    Dr.’s office.

    10 Byetta/1K Metformin @ 2X

    jr

    Posted by jr |
  41. I am not on Byetta at this time I am trying to talk my Dr. in to letting me try Byetta He says ther has not been enough research on the drug. However I am a type 2 diabetic on insulin and I am always hungry and have gained 30 pounds in 3 months. Please tell me should I try to get my dr. to let me try byetta?

    Posted by Zoe |
  42. Started on 5 MCG of Byetta in July been having lower back pain, which seams to be related as it fades or disappears if I skip a doze. I told the doctor about it in October at the physical, and I called the office last week my doctor is outa the country so another doctor called back; but neither doctor was concerned.

    Posted by robert |
  43. i have type 2 and i have used byetta i stoppes taking it a few months ago i had symptoms of pancreatic damage but my doctor blew it off as a virus i was diagnosed in april with acute pancreatitis and i believe it is due to the drug

    Posted by chris |
  44. I just started taking byetta went from 5mg to 10 and no nausea or vomiting or other signs except this odd burning aching in the middle of my back, Ill usually get within an hour of takin byetta… So im gonna wait it out a couple weeks and see if it continues or if other symptoms occur….

    Posted by angela |
  45. I’ve been taking it for only one week, and I just started developing lower back pain as well. I will report it to my Dr. but I’m not sure what to think of it. I also noticed that I’m having frequent urination. Whatever the case I will be getting it checked out.

    Posted by Mrs. Tubbs |
  46. I meant one month

    Posted by Mrs. Tubbs |

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