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Diabetes Developments - A blog on latest developments in diabetes by David Mendosa

A Byetta Pancreatitis Perspective

October 18th, 2007 · 4 Comments

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A couple of days ago the Food and Drug Administration sent out an alert that it suspects a connection between some of the 30 reported cases of pancreatitis among people with diabetes who take Byetta and the fact that they are taking it. The FDA’s alert disturbed Wall Street.

Amylin Pharmaceuticals, which developed Byetta, on Tuesday saw its stock drop sharply. It went from about $48 per share to $43.95 before bouncing back to close at about $46 today.

Pancreatitis is definitely a serious complication. If you have “persistent severe abdominal pain which may or may not be accompanied by vomiting,” the FDA says to get immediate medical treatment. That’s true, of course, whether or not you are taking Byetta.

But people who are more familiar with Byetta than most investors – including those of us who are taking it, their doctors, and industry observers – are less concerned about the possibility of a connection with pancreatitis. I’ve received several email messages from Byetta users in the past couple of days, and no one I know is discontinuing it. In fact, one good diabetes resource specifically says, “Don’t stop taking Byetta. The FDA is not recommending that doctors stop prescribing Byetta. The drug is successful at treating type 2 diabetes for most people. If you have concerns about taking Byetta, discuss them with your doctor.”

If your doctor is as knowledgeable about Byetta as Dr. Joe Prendergast, an endocrinologist practicing in San Francisco, he will probably tell you to relax. Dr. Joe says that he has more than 500 patients on Byetta, and none of them ever showed signs of pancreatitis. He is not going to take any of his patients off it.

“I don’t think that it is a real serious concern,” he said on his video podcast this morning. Full disclosure: Dr. Joe wrote the forward to my forthcoming book, Losing Weight with Your Diabetes Medication: How Byetta and Other Drugs Can Help You Lose More Weight than You Ever Thought Possible.

Twenty-seven of the 30 cases reported to the FDA involved patients had at least one other risk factor for pancreatitis. One of those risk factors is drinking a lot of alcohol. Many heavy drinkers have pancreatitis, Dr. Joe says. If they are using Byetta too, he would not be surprised if they developed pancreatitis.

Industry observers like David Kliff, the publisher of Diabetic Investor, has an investor’s perspective on Byetta. He emphasized yesterday that the FDA did not state that Byetta caused pancreatitis in even all of the 30 cases.

When you keep in mind how rare even 30 reported case are in comparison with the number of people who are taking Byetta, this is “a non-issue,” Mr. Kliff says. “There are more than 700,000 patients using Byetta and 30 reports of pancreatitis. That’s 0.00428 percent or 1 case in 23,364 patients. That’s rare.”

He also points out that this report isn’t news. In fact, I’ve been reporting on it for a long time. In August of last year I responded to a comment about pancreatitis among Byetta users by directing readers to an excellent article by Kelly Close.

She reported that a Wall Street analyst found 24 unique cases of pancreatitis associated with Byetta from August 2005 through January 2006. Most telling to me was, “Only one of them was reported in 1Q06, which implies a decreasing incidence rate. Taken alone, the rate in 1Q06 is actually much lower than the rate of pancreatitis in the general population. This is contrary to what we would have expected since more people continue to start on Byetta over time.”

Now, of course, it’s six quarters later. In that time it looks like the FDA turned up just six more reports of such a connection.

Kelly also tellingly quoted another analyst, Thomas Wei of PiperJaffray, as saying that almost all diabetes drugs have reports of rare serious side effects. He specifically mentioned reports of pancreatitis with metformin.

In fact, just one day after the FDA’s alert on Byetta, Merck announced its own alert for another hot new diabetes drug, Januvia.
The company said it had received reports that some people taking Januvia had developed serious complications, including a potentially fatal skin condition called Stevens-Johnson Syndrome and other serious allergic reactions.

“It’s not possible to establish a causal relationship,” John Amatruda, Merck’s vice president for clinical development, said in an interview. “We don’t know what other medications these patients were on.”

That’s precisely the problem. We need to keep the same perspective on pancreatitis.

This is a mirror of one of my articles that Health Central published. You can navigate to that site to find my most recent articles.

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Posted in: Medication

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4 responses so far ↓

  • 1 Barb // Jun 7, 2009 at 7:10 pm

    I’m curious. This is dated October 07. Are you still on Byetta? I was on it 3 yrs. when I started having stabbing abdominal pain. I experimented myself by stopping the byetta for a couple of days. Pain basically stopped. I started the byetta again and the pain returned. As far as drinking, I had a small glass of wine MAYBE 2 times a week. So to be on the safe side I chose to stop the byetta.

  • 2 David Mendosa // Jun 8, 2009 at 2:34 pm

    Dear Barb,

    Thanks for asking. I used Byetta for about 2 years until December 07. By that time I had lost so much weight and controlled my diabetes so well that I determined to try to live without any medication. The only way to do that and stay on top of my diabetes was to go on a very low-carb diet. I still follow it and with a lot of exercise I have controlled my diabetes even better (A1C of 4.8 now) and lost even more weight (BMI of 19 now). And like you I have stopped drinking alcohol.

    Best regards,

    David

  • 3 Kim Clinton // Jan 30, 2012 at 7:24 pm

    Hi David why did you stop drinking alcohol? I drink a glass a day of red wine because I read it was good for you

    Also I cant get my Dr to prescribe Byetta Even though I cant lose weight even off of medication she insists I am type1 because I became diabetic ss an 11 year old I cant lose weight and insulin makes me really blow up like a balloon. How do I convince her? I have an HMO and the Docs are inflexible cant get to see an endocrinoligist because the gatekeeper docs think I need to just shut up and take the insulin Byetta worked for my brother who became type 2 at age 18.

  • 4 David Mendosa // Jan 30, 2012 at 7:34 pm

    Dear Kim,

    I forget now why I stopped! But I started again. Some.

    Actually, a sister drug to Byetta name Symlin, also made by Amylin Pharmaceuticals, is specifically for people with type 1 diabetes. You might suggest to your doctor that you get on that.

    For a discussion of both Symlin and Byetta please see the post by my friend Scott Johnson and all the comments.

    David

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