Byetta Garners Pancreatitis Warning :: Diabetes Self-Management

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Oct 23, 2007

Byetta Garners Pancreatitis Warning

Jan Chait

Good grief. Here we go again on problems with a diabetes drug. It seems we’ve just gotten through the possible heart problems with the thiazolidinedione class of drugs and now we’re onto problems with another class. This month—oops! make that this time—it’s exenatide (brand name Byetta), which appears to be connected with pancreatitis.

Exenatide, approved by the U.S. Food and Drug Administration (FDA) in 2005 for use in controlling Type 2 diabetes, is a synthetic form of a substance found in lizard spi...er, the saliva of gila monsters.

Before I continue, I'm going to point out that there were only 30 cases of pancreatitis reviewed by the FDA out of what I've heard are half a million or so users. Also, 27 of the 30 people had other contributing factors such as gallstones, alcohol use, or triglycerides that were w-a-y too high.

And now, back to our regularly scheduled blog.

Also according to the FDA:

Pancreatitis symptoms got worse after the dose of Byetta was increased from 5 micrograms twice daily to 10 micrograms two times a day;
Twenty-one of the 30 people were hospitalized; and
Five of those developed serious complications, which included dehydration, kidney failure, intestinal obstruction, tissue inflammation, and abnormal buildup of fluid in the abdomen.

Twenty-two of the reports said the people improved after they stopped taking Byetta. In other cases, the symptoms returned after the person started taking the substance again. Which begs the question: Why? Why, that is, did they start taking Byetta again after going through pancreatitis which, I understand, is very painful? If I do something and it results in extreme pain, I tend not to want to do it again.

At any rate, the FDA has asked Byetta's manufacturer, Amylin Pharmaceuticals, Inc., and it has agreed, to include information about pancreatitis in the product label's "precautions" section.

What signs should you look for? Well, if you experience nausea, vomiting, diarrhea, indigestion, and upper abdominal discomfort, those are common side effects of Byetta.

If, however, you have unexplained, severe abdominal pain, with or without nausea and vomiting, you could have acute pancreatitis, which is potentially very serious. Call your doctor or get yourself to a hospital. However, I don't believe you'll need to be reminded to call the doc or get to a hospital: A friend of mine who had acute pancreatitis a few years ago said she felt like she was dying and couldn't wait to get to the hospital.

As I said at the beginning of this blog entry, the information about Byetta and pancreatitis comes shortly after the FDA ordered the thiazolidinedione class of drugs to carry the agency's toughest "black box" warning that the drugs are linked to an increased risk of heart failure. Brand names of the drugs affected are Avandia and Actos, as well as the combination drugs Avandamet and Avandaryl (which contain the same active ingredient that's in Avandia) and Actoplus met and duetact (which contain the same active ingredient that's in Actos).

According to an article by Dow Jones, "Avandia and Actos have long been shown to increase the risk of heart failure, a condition that develops over time and is characterized by the heart's inability to properly pump blood and is different from a heart attack."

Back in March 2000, the FDA ordered another thiazolidinedione drug, troglitazone (brand name Rezulin), to be removed from the market because it was shown to cause liver toxicity.

Personally, I'm not too concerned about Byetta, not only because I don't take it, but because there are so few cases of pancreatitis and most of those had other contributing factors.

But it seems to me that I'm hearing more and more about drugs having adverse affects after we have basically acted as human guinea pigs for the drug companies. Remember hormone replacement therapy and its link to several conditions, including breast cancer and heart disease?

Oh, I know that clinical trials don't last long enough to get a real picture of what could happen on a long-term basis. And it's not just diabetes-related drugs that encounter problems after they've been on the market for a while. I just know that I have enough problems caring for diabetes without risking my body's health by unquestioningly taking whatever the doctor prescribes for me.

While I also don't take any of the thiazolidinediones either, I'm not sure I'd want to take something that raises the risk of heart problems when I already have diabetes, which in itself increases my risk of having heart problems.

What I do is ask questions—a lot of questions. And one of those questions is "is there a drug that's been around for a while that will do the same thing?" For one thing, safety is more proven on older drugs. For another, they're usually available in generic form (i.e., cheaper!). To me, that not only makes sense, it makes cents, too.

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I had used Byetta for just a month. I had recieved the injection style pen from my doctor as a trial prescription. It had worked great for reducing my appetite. When I tried to get it through my prescription plan, I had run into a lot of rejection from my plan. I take insulin and did not know anything about the problems with it at the time. After reading the above article, I am glad I couldn't get the prescription.

Posted by: tldell | Oct 24, 2007 05:03 PM

30 out of half a million... Hmmmm. Wonder what the chances of getting pancreatitis are if you AREN'T using Byetta? I have a friend who recently was hospitalized. Non-diabetic, she had gallstones.

I don't think I'd stay away from Byetta if my Dr decides to prescribe it (we have discussed it, but haven't gotten to that point yet)

HOWEVER, I am concerned about being a guinea pig for the drug companies. I, too, prefer to use "tried and true" meds before moving to newer versions. Like Jan said, I already have enough medical problems without adding more because of an untested (long-term) medicine!

Posted by: Ephrenia | Oct 24, 2007 07:43 PM

This drug has been a miracle for me in controlling my diabetes! I went from a HbA1C of 9-10 to 6 in a couple months and I have had normal blood sugars for almost a year. I still have to watch what I eat and continue to exercise. I've lost 45 lbs since starting Byetta. The only caution I would give people about it is that I had to stop taking it when I had surgery in June. It slows down your intestinal movement and combined with the same type of effect from narcotics for pain I developed a paralytic ileus that quickly resolved once I was off Byetta for a couple days. As soon as everything returned to normal I was put back on Byetta and I have been fine since. I occasionally have nausea but it's tolerable, especially since my blood sugar is so good.

Posted by: Karen | Oct 24, 2007 09:23 PM

After using diferent oral medications to control my diabetes for 45 years, I was finally having trouble to maintain good control. My endocronologist started me on Byetta 5 micrograms twice dailyfor 3 months with out the desired results, but with very little side effects.He then upped to 10 micrograms twice daily. The results improved significantly, in 2 months use.I also ended up in the hospital emergency room. After different tests and blood work, I was told that I had acute pancreatitis,abdominal obstruction and kidney failure.I am now using Lantus with better results wth the exception of weight gain.

Posted by: Rodney | Oct 24, 2007 09:29 PM

I have been on Byetta for almost 2 years now... It has been a wonder drug for me... You don't know how well a drug will work for you, IF you are not willing to try it....

Posted by: Levita | Oct 24, 2007 09:47 PM

I TAKE BYETTA, I HAVE NO PROBLEMS WITH IT. I HAD A NEEDLE PHOBIA AND I WAS OBESE, I HAVE LOST 20#'S IN LESS THAN A YEAR, I WILL KEPP INJECTING BYETTA, IT HAS DONE GOOD THINGS FOR ME AND I FOR ONE WILL STAY ON IT!!

Posted by: DOGMAMA | Oct 25, 2007 12:16 AM

I have been on byetta for about 6 months and don't have any of the side effects other then nausea feeling sometimes. I also have other medical problems,but hoping that this will continue to work for me. It has brought my blood level down some and as far as the weight I haven't had any luck with that working for me. I wish, as I am obese also. Any tips would be helpful. Thanks Diana

Posted by: ladydi265 | Oct 25, 2007 05:36 PM

I've been using Byetta for one month now and have lost about 15 pounds. I've had no side effects and actually feel better than ever.

Posted by: Auntdell | Oct 25, 2007 09:41 PM

I look up every little thing on every new drug I have to take. I knew about the heart risk with both avandia and actos (including the small bone breakage with actos) and the byetta along with the anti-depressants I take (ie suicide risks; it's there if you read it). People need to read up on this stuff and ask questions, no good doctor will ignore questions. I have been on byetta for over a year and am having some stomach problems which I told my internist/endo about just the other day. We discussed it and am having a blood test done and am going for an ultrasound on my stomach. I was prepared for this so I am not so concerned. If we all waited for clinical trials to finish going over every little side effect, there would be no drugs at all.

Posted by: Linda | Oct 26, 2007 01:48 PM

So--you all want a tried and true Rx? It takes those of us willing to try new things for something to become tried and true.

I've taken Byetta since June 2005 with good results. I am helping Byetta become tried and true so all you others holding back can reap the results of my willingness.

Posted by: Marcia | Oct 27, 2007 11:10 AM

I have been taking Byetta for over a year, with only a little nausea in the beginning. The only problem for me has been low blood sugar, recently, in the evening after dinner. I take the 10mg before breakfast and before dinner. I underwent a treatment for cancer, which caused me to gain 40 lbs. Since resuming Byetta after the treatments, I have lost 15 lbs. I'll stay with it, if my doctor can help me solve the low blood sugars.

Posted by: SMA1957 | Oct 28, 2007 08:15 PM

I HAVE BEEN ON BYETTA FOR 8 MONTHS. IT HAS BEEN A MIRACLE FOR ME. AIC WENT FROM 10.5 TO 6.7 IN 3 MONTHS ON 5 MCG. WENT TO 6.0 IN NEXT 3 MONTHS ON 10 MCG. LITTLE TO NO SIDE EFFECTS. NO WEIGHT LOSS UNTIL I STOPPED ACTOS RECENTLY. BG READINGS SEEM UNAFFECTED BY STOPPING ACTOS (AGAINST MY DOC'S RECOMMENDATION) BUT ALL SEEMS WELL RIGHT NOW. I HAVE BEEN CONCERNED THAT SOME SERIUOS SIDE EFFECT WOULD ARISE WITH LONG TERM USE OF BYETTA. HOWEVER I AM NOT PANICKING OVER THE PANCREATITIS SCARE SINCE THE INCIDENTS SEEM SO LOW. LETS' ALL HOPE NOTHING ELSE NEGATIVE DEVELOPS. THE GILA IS TO GOOD TO BE TRUE !! PRAY THAT STAYS THAT WAY !!

Posted by: JOHNBOY | Nov 02, 2007 02:36 PM

I am one of the 30. My Dr. reported my case. When it happens to you, the pain is such that you will want to avoid it at all costs.

Posted by: rev. kathy | Dec 17, 2007 02:40 PM

I started with Byetta 5mcg and then was increased to 10mcg BID. The drug worked great in curbing the appetite and controlling blood sugar, until recently...
My glucose shot up, my triglycerides shot to over 1500, I had severe diarrhea, and nauseousness in the morning. I also had tingling in my upper legs and side of my head along with blurry vision. i also have tenderness in my upper abdomen. The doctor has now put me on Lantus, Humulin R, glimepride, and glucophage, inaddition to Tricor for the triglycerides. I am going for tests to see the status of my pancreas this week.

Regretfully, no one was aware of the side effects of Byetta. I found this out after the fact. The reason youprobably haven't heard more cases is no one knows about it yet. The message needs to be delivered and better publicized. I pray I will be okay along with everyone else.

Posted by: Shadow9 | Dec 20, 2007 01:01 PM

I've been using Byetta for about 1 year. It's been great for me. My A1C has been 6.7 the last 2 times I had it checked. Byetta has reduced my appetite and sometimes I do get a little nausea but other than that all is well. So far so good!

Posted by: ray of light | Jan 24, 2008 05:15 PM

My husband was on Avandia for Type II diabetis for years and last year he was told to increase his dosage and one month later he developed pancreatitis. One month after that while in the hospital in the ICU and had a heart attack and died. He always took care of himself with the diabetis. I am in the process of sueing the hospital and doctors in the hospital. He was a very healthy person his whole life. I lost my husband and best friend to this drug.

Posted by: lindas66 | Jan 31, 2008 09:02 AM

Our choice. I started taking Byetta in November of 2005. It was a new drug and I am ever aware that drugs reach the market with little info on long term effects. I take only my diabetic meds and an occasional aspirin when headaches or arthritus gets to the point of nausea.

I weighed very, very carefully the possiblility of unknown long term side effects. However, diabetes is a progressive disease and a slow killer. I made a conscious decision that it was worth any risk that might crop up. I feel so much better and my A1c is now 6.2 as opposed to 9.8.

Folks, we have a responsibility here to keep informed and to be in tune with what is going on with our bodies and make changes as necessary.

All medications are options. Do your research, make your choice and then take responsibility for the consequences.

Remeber, the drug companies are in it for the almighty dollar - not because they care about our health!

Posted by: Sherry in Dayton | Feb 02, 2008 10:26 AM

My Father began taking this drug in Dec 2006 and passed away June 2007 with 80% of his Pancreas damaged. When looking at the box no where on it does it state that this could be a side affect nor did any one put it together that this drug could have been the cause of death.

Posted by: dm | Feb 02, 2008 02:01 PM

I've been taking Byetta for about a year now with little to no side effects other than nausea in the beginning. Sorry to say no weight loss in my case. I take it with Glyburide/metformin. My BG has been improved with my last A1c 7.0.(down from 11). Just lately I have had some low BG in the evenings after dinner but all I need to do is eat a little something. I can always feel it coming on in time to correct it.
All in all, even with the recent warnings I think it's an effective drug for this disease and will continue using it. I'm sorry for those who have become ill as a possible side effect. Maybe there were other factors involved as well.
There are risks involved with any medication and we all have to decide what is right for ourselves.

Posted by: kendon11 | Feb 11, 2008 08:00 PM

It may seem to those who have not taken Byetta and developed pancreatitis, that this is much ado about nothing. Let me assure you after developing pancreatitis which led to diabetic ketoacidosis, it is not much ado about nothing. I spent 13 days in the hospital, and 8 of these days were in ICU. THIS IS A SERIOUS SIDE EFFECT.

Alice Brusnighan

Posted by: Alice Brusnighan | Apr 26, 2008 03:23 PM

I have been on Byetta for 2 yrs.No major trouble until A week ago. I suffered with severe abdominal pain for 2.5 days. Finally I looked up this web site for info. after reading some of the blogs I took myself to the emergency. After a lung x-ray, EKG, ultra sound of my gallbladder and liver, urine tests and blood tests. The blood tests came back with pancreatitis. Not a drinker, no family history of gallbladder trouble.They told me to stop the Byetta and call my Dr. which I did the next am. The nurse wouldn't believe what I had told her. Even after I had the results faxed to her.(My Dr. was out of town) She made me go to another ER in a different city. I was put through the same blood test and EKG and after 5 hrs was told pancreatitis. By the time they got all the results the Dr's office was closed!! Of course this was on a Friday. As of today I'm still suffering with pain on my upper left under my ribs, but much less pain. My blood sugars are rising.( I'm being very carefull of what I eat) I have yet to hear from my Dr's office. So for now no more Byetta. I will not take it again. I do have a Dr's appt next week. which happened to have been scheduled a long tima ago.Lucky me!

Posted by: D. Medley | Jun 10, 2008 06:55 PM

I'm new to Byetta but I'm not too happy so far. I'm plagued by nausea; to the point that I'm not sure I want to continue the drug. I have been surfing around the web to see what I can find and I'm hearing more about how it can cause heart problems. Somehow it affects the hart so that it does not pump blood effectively. I have very high cholesterol and triglycerides. Untreated my cholesterol is about 1000 and my triglycerides 2500 so anything about the heart worries me. I'm going to try to continue until my next doctor's appointment so I can discuss all this with her. But I don't think I will continue the drug.

Posted by: Victor Johansen | Aug 06, 2008 03:13 PM

I'm newly diagnosed type 2 diabetic (3 months) and had previous heart disease. My doctor wants me to first try to control it with weight loss and diet management. He sugegested trying Byetta (no other diabetic drugs) as evidence points to it helping with weight loss and BS control. I started with 5 mcg then after 3 weeks was started on 10 mcg to get better BS control. I have lost 20 lbs to date, probably because of the lack of appetite and nausea, sometimes extreme nausea. I vomited once due to the nausea. On occasion, with the nausea I also get nasal congestion (20 minutes after injecting the med) along with feeling cold even with the outside temperature in the 80-90's. My diabetic educator (NP) said she never heard of anyone getting congestion and feeling cold with Byetta. Has anyone else experienced these additional symptoms (not listed on the package insert either)? Also, for those who experience nausea, how long did it last before you stopped feeling it enough to interupt your daily activities? I don't always feel so bad but sometimes it's enough to make me need to lie down for an hour or two, which is impossible with working in an office cubicle. The news today about Byetta (18 AUG 2008) has my husband suggesting strongly that I stop taking this med but I still have 40-55 lbs to lose. I don't want to be foolish but and like others have stated, many people have taken this med successfully compared to a smaller group who have had extreme side effects. All comments are welcome.

Posted by: Connie | Aug 18, 2008 05:19 PM

Dear Jan. God does not make it easy for diabetics. Here was a drug that could control BG and help you loose weight, one would think a miracle. Reading the comments it appears that pancreatis is a very serious condition. Hope that it is very infrequent with the use of this promissing drug. Again makes you wonder if insulin is the drug of choice for treating diabetes. It has all the advantages except for weight gain sometimes massive.

Posted by: CalgaryDiabetic | Aug 19, 2008 01:45 PM

I've been using Byetta since November 2007. I lost 25 pounds in the first 40 days and and have lost another 30 pounds since. My A1c is down for 8.4 to 5.6 which I haven't been able to do in years. Since starting Byetta I have been able to stop using Advandia and Amaryl completly just using Glucophage only along with Byetta now. For me this is a miracle drug, I'm down to a normal weight in range for my height. The only thing I have noticed is I can not eat raw veggies as much as I used to they tend to turn me off for 2 to 3 hours after injecting the Byetta. Other than that all is well!

Posted by: Karen | Aug 19, 2008 04:10 PM

Ok, someone put an article in my mailbox today about Byetta. I am going to tell you my observation as a Byetta user since Sept. 2007. I am 40+ lbs lighter. In the beginning I was taking 5mg twice daily. After one month I was moved to 10mg twice daily. The nausea was unbearable some days and even now I have evening nausea after the dinner meal. If I lay down it will go away. I didn't agree with them when starting the medication "waiting one hour" before eating. That was way to long, I shorten it waiting only 30 mins. after talking with the makers of Byetta. The nausea subsided tremendously after that. Now after nearly 1 year my BS is never above 140 after meals and less than 100 always in the morning before meals. My A1C is a remarkable 5.6 and most of the time I feel great. This is the problem. 3 weeks ago I went to ER with severe right flank pain that I was unable to control. 2 CT Scan without contrast and 1 CT Scan with contrast they aren't sure what is wrong. They suspect my appendix. After 10 days of flagyl and levaquin my "angry appendix" is back to normal but my pain is still off and on. No kidney stones shown on CT and the doctors say they want to watch me for 2 weeks and do another CT. Geezer, I am about to get over all of this. I have been to 3 doctors and have another appointment with my GP to make a decision. I love the weight loss, my BS reading, but I am concerned about what is going on with my body. Any thoughts? As far as the right flank pain I was told by the doctors that appendix pain can refer to the back. I didn't know that. Please let me know if anyone has experienced my story of pain. I need some answers to make my decision. Thank you!

Posted by: turncalf | Aug 19, 2008 07:52 PM

Hi,
I am a newbe in the diabetic relm. My doctor started me on Byetta a few months ago and has now moved my dose from 5 to 10. I just read about Byetta and Pancreatitis in our local paper. I am scared to death! Should I continue using Byetta or not? Is there an all natural regime I can use to control BG? My A1c is at a 6.0 from a 6.5! What is the healthy range for BG. I'm glad I'm not nauseated anymore! but these days what is the safest way to control BG? I would feel a lot better doing it the all natural way! My mom and dad have diabetes too. Mom died a few years ago and dad is struggling with his BG. He is constantly eating everything in site. I recommended to my older sister (his caregiver) to have the Dr. put him on Byetta! I hope that wasn't a mistake on my part! What do I do?

Posted by: carlamae40 | Aug 19, 2008 08:25 PM

Hi,
I was diagnosed with type 2 diabetes in April. I started taking glucophage and then added Byetta. My doctor started me on 5 mg once per day and moved me to 10 mg twice a day about 6 weeks ago. I have learned to deal with the nausea and have adjusted my eating habits knowing what I can and cannot eat. I do have trouble eating any meat and do experience vommiting occasionally. I am losing about 1 lb per week and so far a total weight loss of 14 lbs. I am somewhat concerned about the pancreatitis side effects but will not stop byetta because of the possibilities. My doctor suspects that in 3 months he will be able to eliminate by blood pressure and cholesterol medication. That is something that would not have been possible without byetta. For me the benefits outway the risks. All medication has some risk associated with it. My AIC is the best it has been in 2 years and my cholesterol and BP is almost normal.

Posted by: storey | Aug 20, 2008 10:54 AM

Don't panic! You can get pancreatitis without taking Byetta and you can take Byetta and not get pancreatitis. The number of people who have gotten pancreatitis while taking Byetta is a very small percentage.

The main thing is to be aware of any adverse symptoms. As it mentions in the blog, nausea, vomiting, diarrhea, indigestion, and upper abdominal discomfort are common side effects of Byetta.

On the other hand, unexplained, severe abdominal pain, with or without nausea and vomiting, could mean you have acute pancreatitis, which is potentially very serious. Don't keep on taking it to see if the symptoms will go away: Call your doctor or get yourself to a hospital.

If you're uncomfortable taking Byetta, then talk to your health care professional about alternatives. Don't just stop taking it. Running consistently high blood glucose levels is probably a lot more dangerous than taking Byetta.

Jan

Posted by: Jan Chait | Aug 20, 2008 02:05 PM

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