Sunday, June 03, 2012

U500 insulin: a potential safety issue

By Dr. Bill Quick, Health Pro Monday, September 08, 2008
The FDA just released its first quarterly report of drugs with "potential safety issues." A discussion of the concept is posted at FDA to Post Quarterly Report of Potential Safety Issues, and the first report is for the first three months of 2008.   As the FDA points out, "The information...
Diabetes Drugs and Clinical Trial Results
9/ 9/08 4:43pm

I still only see u-500 R insulin very rarely on patient med lists, but from my experience as an RN/CDE talking to patients across the country, it appears it is being prescribed more frequently in the past year or 2. I ran across my first case several years ago, and have talked to maybe 4-5 patients on it since then. U-100 Regular insulin can be purchased directly from a pharmacy without a prescription, but u-500 R insulin REQUIRES a prescription. Most pharmacies usually don't stock u-500, and have to special order it for patients.


Anonymous
Ruby Davis
1/19/09 7:22am
My diabetic doctor just put me on U-500. My average readings are 250-275. I just started on the pump in October, 08. My question is: The doctor in the emergency room diagnosed me with CHF. This gave me a real scare. He put me in hospital and when my doctor finally got back, she told me not to worry that the numbers seem to be very low in I believe enzymes. This morning I've got the swelling of the ancles and legs. Also, I show a wt gain of 5 lbs. I have the drug for swelling and take one a day. DO you think I should go to the doctor with these problems?
Dr. Bill Quick, Health Pro
1/19/09 9:21am

It's difficult to be sure based on the information you've provided, but the best answer I can think of is

 

"Yes."

 

Best wishes,

Bill

William W. Quick, MD, FACP, FACE

 

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9/29/10 3:55pm

Yes, Ruby, you should go to your doctor immediately.  I was diagnosed with CHF last year and didn't know I had it until after I was diagnosed with blood clots in both lungs.  My heart ejection factor was 20-25% (normal is 50-55%).  My heart was unable to pump the blood fast enough so I got clots.  Since then, I have had a pacemaker/defibrillator put in (no big deal) and my ejection factor is back to normal.  I feel so much better and have more energy.  My sugar readings are not way out of control and my doctor just prescribed U-500, which I will begin Friday.  Please see your doctor soon so you don't have more problems.

Anonymous
Felicia Munoz
3/ 8/09 3:56pm

Hello my name is Felicia Munoz and I am inquiring about the serious side effects.  My father is a insulin dependent and ever since he started this new insulin u-500 he has swelled up like a balloon.  It's like he has two additional side breasts under his arm pit and his belly looks like he is about 13 months pregnant and it is very hard, his face-jaws and throat are also very swollen, his last complaint is his legs below the knee are swollen and achy.  He also has a hard time breathing just in the house chores or even getting dressed he is very short winded.  Could someone give me some advise or direct me in the right direction??

Dr. Bill Quick, Health Pro
3/ 8/09 4:25pm

It's not possible to make a diagnosis of what's happened to your dad, and whether it's related to the U500 insulin or not. It may be his heart, kidneys, or perhaps something else acting up.

 

I really have to suggest that your father be evaluated by a physician urgently. If this has ballooned up over this past weekend, he should be seen at an emergency room today, as there's no way to tell if it will continue to worsen. If it's been building for a week or more, he should be seen in the next day or two. If the physician is unable to schedule an appointment, either a consultation to a cardiologist, kidney doc, or  an emergency room should be recommended, depending on what your dad's physician knows about his general health and his heart and kidneys.

 

Best wishes to your dad; hope this helps.

3/ 8/09 6:53pm

DEAR DR. QUICK YES THE INFORMATION THAT YOU GAVE ME IS A BIG HELP.  I'VE TALKED TO MY MOTHER SINCE MY LAST COMMENT AND SHE SAYS ALL OF HIS BLOOD WORK CAME BACK O.K. AND HIS HEMOGLOBIN IS PRETTY MUCH NORMAL.  HE DOES HAVE AN APPOINTMENT WITH HIS KIDNEY DR. TOMORROW AND HE PASSED HIS STRESS TEST AT A NORMAL LEVEL.  THE MOST RECENT THING IS THE INFLAMMATION OF HIS LEG MUSCLES.  COULD HIS LEG SYMPTOMS BE A WHOLE NEW DISORDER?   THANK YOU,  FELICIA MUNOZ

7/16/10 10:22pm

I have been insulin dependent for about 14 years, and I also started to swell extremely! After several months and quite a few specialists later I was diagnosed with autonomic as well as peripheral neuropathy. Have your dad checked for this because a lot of the symptoms you described I also have. I hope this has been helpful. Best wishes and God bless.

 

Anonymous
Anonymous
7/ 5/09 10:37am

I have been on U-500 for two years, my 19 year old granddaughter has also been on u-500 for two years. She is in the hospital with a feeding tube because  her stomach has shut down, she also has to catherterize herself as she cannot urinate. I also had a stomach shut down but was able, with my doctors help, to get it restarted. I and my grandauighter have gone off U-500. I am doing much better now, but unfortunately it appears to little to late for my granddaughter she is not improving, Was all this caused by U-500, obviously we cannot conclude that is was , but for me I am not willing to risk it further and will not be using U-500 any longer.   

Dr. Bill Quick, Health Pro
7/ 7/09 8:54am

It's not clear why you were placed on U-500 insulin. If you are under the care of a diabetes specialist, please discuss your concerns with him/her. If not, I'd strongly suggest you ask for an evaluation by a diabetes team that includes a diabetes physician and a certified diabetes nurse educator.

Best wishes

2/24/11 8:07pm

Hi--After 6 months of severe insulin resistance and 3 physicians telling me insulin resistance is normal for IDDM, my new endocrinologist today (seeing him since January--increasing doses and switching insulins-U-100 from humulog, humulin R, Lantus. Apidra, NPH, Levimir and Novolog) finally decided to put me on U-500.  My A-1C's went from 6.4 to 8.5 on more than double the dose of U-100  insulin.    

   I got my family doctor to run the anti-insulin antibody test (against my endocrinologists advide--he was PO'd when he found out) and my anti-insulin antibody was 4.9 (H) out of a normal value of below 0.4 for that lab.    

   My Endocrinologist felt this is normal in type 1 diabetes. I gained 25 pounds, my feet ulcerated, my kidney and liver funcions went abnormally high. 

    My combined dose of  Novolog/Nordisc Levimir (26-untis  twice dialy every 12 hours ) and Novolog - (avg. 95-110 units per day) will be replaced tomorrow afternoon  (after my pharmacy receives Lilly Humulin U-500).

   I was told by doc today to take 8 units of U-500 three times a day so I just was doing some research.  I have many U-100 syringes and suppose 8 units is ok since I didn't get a RX for u-500 SYRINGES.  Am I correct?  I read twice daily is a normal U-500 dose since it lasts 24 hours.  I am a little concerned about 3 doses (especially my bedtime snack dose) giving me overnight hypoglycemia, dawn phenemona and eventual Smoji effect (rebounding) later on in the morning.

   Any advise??

drew4hd@aol.com

Dr. Bill Quick, Health Pro
2/25/11 2:19pm

Drew: I don't think there are any U500 syringes, so use the U100 syringes. Remember that U500 is 5 times as concentrated as U100 when you use the U100 syringes, so be sure to check with your physician whether he wanted you to use the 8-unit mark on a U100 syringe when he advised "8 units" (if you use the 8 unit mark on a U100 syringe, you're actually giving 8x5=40 units of U500 insulin) or whether he wants you to use the 1.6 unit marking on the U-100 syringe (8-divided-by-5).

 

Whether your dose should be split to 2 or 3 separate injections per day is something you also ought to ask your physician about. Remember, most people reuse their syringes, and you probably can, too.

9/12/11 12:59pm

I started using the U500 insulin about a month ago as I've had diabetes for 15 years and was using Novalog but still with high blood sugars.  The U500 is very effective and my blood sugars are now in control.  In my case a nurse went over the use of U500 insulin when the doctor 1st prescribed it and cautioned it was concentrated and reiterated the dosage the doctor had told me.  The pharmacist also repeated this warning--there is also red letters on the bottle: "Warning-High Potency Not for Ordinary Use."  So it seems like in my case I was well informed.  You do wonder though if all health workers (e.g., emergency rooms) are also educated on this.)  It is nice to only have to take two shots a day instead of the 4 before, which was 3 shots of Novalog and 1 of Lantus at night.  The disadvantages are that it only comes in a bottle and not in the pens so you must use a needle; you must be very careful with the dosage on the needle as even one unit high can make blood sugars lower.  Now that I'm use to it I like it much better and the benefits of having controlled blood sugars make the disadvantages minor.

Anonymous
cooper
10/ 7/11 10:43am

  The U500 is sold in 20 m vials and the U100 is in 10m vials,easy to tell the differance

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By Dr. Bill Quick, Health Pro— Last Modified: 03/13/12, First Published: 09/08/08