Byetta news

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mrfino Posted: Tue, Nov 3 2009 1:31 PM

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On October 30, the FDA approved BYETTA as a stand-alone medication along with diet and exercise. My endo previously mentioned the possibility that I could stop taking metformin since Byetta has helped me so much (A1C down to 5.8). Wonder how long it will take the insurance company to catch up and agree to pay for the Byetta whether or not I'm on another med.

Also...

 

FDA NEWS RELEASE

For Immediate Release: Nov. 2, 2009

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA: Byetta Label Revised to Include Safety Information on Possible Kidney Problems

The U.S. Food and Drug Administration today acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes.

From April 2005 through October 2008, the FDA received 78 reports of problems with kidney function in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems.

Nearly 7 million prescriptions for Byetta were dispensed between April 2005 and September 2008. The 78 cases represent a small percentage of the total number of patients using the drug to control blood sugar (glucose) levels.

The most common side effects associated with Byetta include nausea, vomiting, and diarrhea. These side effects may have contributed to the development of altered kidney function. Kidney malfunction can result in a build-up of waste products in the blood, leading to serious illness or life-threatening conditions.

“Health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems,” said Amy Egan, M.D. M.P.H., of the Division of Metabolism and Endocrinology Products at the FDA’s Center for Drug Evaluation and Research. “Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in mid to lower back.”

Patients who experience any of these symptoms should immediately discuss them with their health care professional.

To help health care professionals and patients better weigh the known risks and benefits of Byetta, the FDA worked with the manufacturer to update the drug’s prescribing information (label). A description of these label changes can be found online.

Byetta is manufactured by San Diego-based Amylin Pharmaceuticals Inc.

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Dee replied on Tue, Nov 3 2009 4:40 PM

Excellent news.  I have been on Byetta & Metformin for years,  I think I need both to control my BS levels.  It has been a good combination for me.  Dee

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mrfino replied on Wed, Nov 4 2009 7:04 AM

I'm also on Byetta and metformin, but I'm curious how I would do without the metformin.  Gotta keep the A1C down or I won't even think about giving up the metformin.

John

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Julie_ replied on Wed, Nov 4 2009 1:07 PM

This is distressing news about the Byetta safety label.  I wondered when I started taking Symlin if it was too new of a drug to take a chance with.  The new information does not seem to affect Symlin, but Symlin has many fewer users than Byetta, so maybe it just hasn't been detected yet in Symlin users.  I did just have my kidney function tested since I had blood in the urine in a lab test, and the technician told me my kidney function was better than his.

Is anyone else concerned about the Byetta warning?

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mrfino replied on Wed, Nov 4 2009 2:12 PM

Concerned about Byetta? Not terribly. I'm no scientist, but I am somewhat proficient in the English language. The FDA press release does NOT say that Byetta CAUSES problems with kidney function, only that 78 people who take Byetta are reported to have had such problems. All those people might have another commonality besides taking Byetta (like perhaps a genetic predisposition to kidney problems), but their consumption of a regulated drug gets the FDA involved whereas the other common things about the 78 reported cases do not invoke the same governmental response. I view the FDA press release as an alert to physicians, along the lines of "we don't have any clue whether Byetta contributed to the 78 problems reported, but keep your eyes open so we can continue to assess whether Byetta does or does not cause kidney problems." I'm getting so much benefit from the drug that I would need something far more definitive to make me think about discontinuing it.

John

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Dee replied on Wed, Nov 4 2009 4:11 PM

I read the warnings and of course I am concerned.  I take my usual precautions against any medication, trying to always be aware of complications. 

John, I am hoping to duplicate your excellent A1C feat at my next testing!  Dee

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jen1229 replied on Wed, Nov 4 2009 4:54 PM

I can't understand the purpose of Byetta for diabetics who are following their diet and taking meds.  I have a friend who is on byeta but she is not at all interested in compliance.  My A1C dropped from 8 to 5.5. I am on inuslin but I would rather take insulin than something like byetta especially if it was going to make me sick.

Jen  - LevemirConfused and Novalog Wink A1c 5.8

 

 

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I take Byetta because it helps keep my bg levels under control.  I went from the high 6's to 5.6 with Byetta and I have stayed under 6 for 4 years now.  Medications won't help anyone who doesn't take them when they are supposed to and eat sensibly.  I don't know if insulin would have had the same affect on my bg levels, but with Byetta you don't have to worry about adjusting the dose for the carbs you eat.  You take the same dose twice a day.  Most people don't have serious nausea with Byetta and minor nausea helps reduce food intake, a good thing.

Bill

"May the Force be with you!"

Diagnosed in 1997; Off all meds except Metformin!! Smile

www.nvhealthy.com

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Dee replied on Wed, Nov 4 2009 7:37 PM

Jen, I gave Byetta a try when Metformin and Prandin stopped working for me.  As we all know diabetes is a progressive condition and for me that combination stopped working.  When my endo at Joslin suggested trying Byetta I jumped at the chance.  So far it is still working well for me.  I know that at sometime the progression will rear it's ugly head and it will be insulin for me.  Until then, I will stay on Byetta and Metformin.  Dee

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