Voluntary Glucagon Recall: GlucaGen
Hey everyone,
I'm passing on some voluntary recall news from Novo Nordisk. If you have their GlucaGen glucagon kit you may want to read on. The text below is the info that I thought to be pertinent from the press release - the entire release can be found here.
Take note of the company's estimation that, "of the 71,215 pens being recalled, four pens could be defective".
Novo Nordisk Inc. issues voluntary nationwide recall of six batches of GlucaGen® HypoKit® (glucagon [rDNA origin] for injection) due to detached needles on the syringe in the kit.
PLAINSBORO, N.J., Sept. 8, 2016 /PRNewswire/ -- Novo Nordisk Inc. is recalling six batches of the GlucaGen®HypoKit® in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI). GlucaGen® HypoKit® is indicated for the treatment of severe hypoglycemia (low blood sugar) in patients with diabetes who are treated with insulin. A syringe with a detached needle cannot be used as prescribed.
Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal. If the blood glucose levels are not quickly restored, continuing hypoglycemia can lead to a decline in brain glucose levels which manifests through a variety of symptoms including cognitive dysfunction, sweating, tremors, convulsion and eventually coma or death.
Novo Nordisk conducted an investigation which showed that a small number (0.006%) of needles could be detached from the syringe in certain batches of GlucaGen® HypoKit®. To protect patient safety, Novo Nordisk is recalling affected batches from wholesalers, pharmacies and patients in the U.S.
It is estimated that out of the 71,215 pens being recalled, four pens could be defective.
This recall includes GlucaGen® HypoKit® batch numbers:
Batch: FS6X270, Expiry: 09/30/2017
Batch: FS6X296, Expiry: 09/30/2017
Batch: FS6X538, Expiry: 09/30/2017
Batch: FS6X597, Expiry: 09/30/2017
Batch: FS6X797, Expiry: 09/30/2017
Batch: FS6X875, Expiry: 09/30/2017
The affected products were distributed starting February 15, 2016.
Novo Nordisk is working as quickly as possible and in collaboration with the U.S. Food and Drug Administration (FDA) to recall affected products from the marketplace, including those in the possession of patients. To date, Novo Nordisk is not aware of any known adverse events resulting from the use of the recalled batches.
Patients or caregivers should check the batch number to see if their GlucaGen® HypoKit® is affected. The batch number is printed on the GlucaGen® HypoKit® as indicated below in the red box (Figure 1).
Figure 1. A) GlucaGen® HypoKit® where the batch number is found in the red box, B) close up of the batch number.
If you have a GlucaGen® HypoKit® with one of the above-mentioned batch numbers, call 1-888-840-1137 from Monday to Friday, between 8:30am – 6:00pm Eastern Time, to find out how to return the product. Novo Nordisk will provide reimbursement for out-of-pocket costs incurred for the purchase for your affected GlucaGen® HypoKit® with proof of purchase. If you received a GlucaGen® HypoKit® through the Novo Nordisk Patient Assistance Program, you will receive a replacement device.
If you are in possession of a GlucaGen® HypoKit® with a batch number NOT mentioned above, the product is not subject to the recall and may be used as prescribed.
Novo Nordisk Inc. is notifying its distributors and customers by letter and phone and is arranging for return of all recalled products.
Adverse reactions or quality problems experienced with the use of this product may be reported to Novo Nordisk by calling 1-800-727-6500. Patients can also call the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Novo Nordisk is committed to patient safety and delivering high-quality medicines, and is working to take corrective actions and avoid re-occurrence.
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"Because of your podcast (Juicebox), I have significantly reduced the amount of spikes that I get."
BULLSH*T NEWS: Express Scripts diabetes program aims to cap costs for customers
Be 1000% sure that what this means is companies like Express Scripts are battling with insurance companies over the cost of drugs and each entity wants NOTHING more than to spend less money. They will eventually accomplished this by fuc*#$& the patient.
Express Scripts Holding, the largest U.S. pharmacy benefit manager, said on Wednesday it will implement a program next year that guarantees per-patient spending caps on diabetes drug costs in an effort to limit soaring increases for its customers.
U.S. diabetes prescription drug spending increased 14 percent in 2015 and is forecast to rise at an even faster rate this year and next, according to an Express Scripts report.
The company said a goal of its Diabetes Care Value Program is for participants to incur drug spending increases of about half of the industry forecast of a nearly 18 percent rise in 2017.
For example, if an employer is expected to incur a 20 percent increase in diabetes drug spending in 2017, Express might set a per person/per year cap of no more than a 10 percent increase for its employees. Should diabetes spending hit that cap for a plan participant, Express Scripts would cover all excess costs.
"If they go over the cap, we're on the hook dollar for dollar," Glen Stettin, chief innovation officer at Express Scripts, said in a telephone interview.
For many customers diabetes costs will be "significantly less than what they've experienced in the past several years and significantly less than what would have been projected for the future had they not participated in this program," Stettin said.
Prescription benefit managers, which negotiate drug benefits for health plans and employers, have become increasingly aggressive players in efforts to hold down prescription drug costs.
They achieve this by demanding steep discounts from drugmakers in exchange for including their medicines on preferred use formularies, and by limiting use of expensive new medicines to patients who fit certain criteria.
The Express Scripts program also aims to improve patient compliance rates, in part by allowing them to receive 90 days of drugs at one time rather than a one-month supply, either through the Express Scripts mail order pharmacy, or through more than 10,000 pharmacies across the United States, including all Walgreens pharmacies.
More than 29 million Americans have diabetes, according to the U.S. Centers for Disease Control and Prevention.
Patients not taking their medications regularly, often due to high costs or inconvenience, is a constant lament of physicians and can lead to serious and expensive health complications.
(Reporting by Bill Berkrot; Editing by Dan Grebler)
News: Open Source Insulin!?
Oakland Hackers Try to Make Insulin...
Below are a few excerpts from a news story out of California about 'Counter Culture Labs' and the researchers who are using its space to try and create open source insulin. It's worth a read...
from KQED News - By Andrew Stelzer
"The projects are as varied as the participants. In addition to developing vegan cheese, another group is trying to make an eco-friendly sunscreen. And the focus of tonight’s weekly meeting is the Open Insulin Project."
"The goal is to make and purify human insulin, and we want to do that in the simplest and least expensive way possible,” says Anthony DiFranco, who helped start the Open Insulin Project."
"DiFranco’s a Type 1 diabetic himself, which means he needs to use insulin to balance his blood sugar. Here in the lab, he and the team are using E. coli to try and produce something biologically similar to insulin."
You can read the entire story at KQED News
A1C: How We Got To 5.7
I've written blog posts for years about how we've reduced Arden's A1c. I've told you about the OmniPod insulin pump, DexCom continuous glucose monitor, modifying diet, being bold with insulin and more. The process has existed on many paths. We had to conquer school days, overnights, carb rich foods, sports and my fear of insulin. If you search the phrase "A1c" on this site a bevy of blog posts will return and they all highlight a moment of the journey. You'll see us get out of the 9's, the 8's the 7's and finally claw our way to sub 6.
Almost each time that we got the number to decrease I would spend the ride to Arden's endo appointment telling her not to be disappointed if her A1c goes up because I was always trying things and never really sure if they would work. Diabetes is the ultimate on the job training
Last weeks Endo visit was different...
When we got into my car I told Arden, "Your A1c is going to be 5.7, watch and see". I was confident, almost brash when I told her this. Sure I was cheating a little - truth be told - because I have the Dexcom Clarity app on my phone and can see Arden's A1c. But still my confidence was rooted more than just being able to see reports from her glucose monitor ahead of her quarterly blood test. This confidence was bigger than data because I finally know what I'm doing. No more guessing, no more wondering. Today I trust my gut and we attack Arden's blood sugars with a steely resolve. All of our experiences have finally added up and the seemingly senseless actions of diabetes are finally making sense.
The way I arrived at this resolve is why I'm writing today...
In the Spring of 2015 I launched a type 1 diabetes podcast called the Juicebox Podcast. My intention was to share my experiences being the parent of a child living with diabetes in a new medium and hopefully to a wider audience. That was it, no larger or grander plan. I was just starting a podcast. Since then the podcast has reached more people than I could have ever imagined and the response from listeners is largely very positive. Better still, I receive emails, FB messages and tags on Instagram nearly daily from people who want to tell me how the podcast has helped them - those notes are unimaginably wonderful to read. The idea that a persons A1c is lower and more stable, that their life feels calmer and easier to enjoy... that feeling is well beyond any initial hope that I had for this blog or the podcast. I can't lie and tell you that I didn't think the podcast would be helpful but I wasn't able to imagine to what extent or that it would actually also help me.
So how did we get to 5.7? The simple answer is by doing the podcast. It turns out that by taking the time to record the show, by having conversations with other people living with diabetes... I was allowing myself time to consider aspects of my management theories as well. Pausing life for a moment to think about type 1 and how to best approach it. I'm not a pre-planner at heart, I go and work things out as I'm moving. So some of the tactics that you have adopted through the Juicebox Podcast are things that occurred to me while recording the podcast. I took my experiences and spoke about them, during those conversations things came to me that previously had not. My ideas were growing and taking shape as I was sharing them with you. I learned from diabetes, you learned from me and I learned from you. A circle, a wonderful blue circle.
When I decided to stop being afraid of insulin, others followed. You had great success with that idea, I was enthused by your stories. That enthusiasm helped me to chase more fancy, find success and report it back to you. In return you contacted me and some of you come on the podcast to talk about your experiences - another blue circle. When I hear from you that the podcast is helping in your life, that knowledge supports me and we move forward together.
That is what community is...
I cried when one of you told me that your daughter has been playing for hours with a stable blood sugar. Your words, "she seems like herself again" striking me at my core. This exchange is one of the great moments of my life. All I want is for my daughter to have a chance to be herself and live her life. That a podcast was able to bring that dream to another person has made my heart soar.
There are many other stories and when each of them reaches me my desire to continue doubles. You all are the reason that Arden's A1c is 5.7, I have no doubt of that fact. I need to thank each of you and I want to invite you to come with me as I try to keep Arden's BGs stable, her A1c constant and try to make all of our lives better.
The Juicebox Podcast is one of the true surprises of my life. I just never imagined...
I understand that not everyone knows about podcasts or how to find them but it couldn't be simpler. iOS users on iPhone and iPad only need to click this link, you already have a podcast app. Android and Google Play folks can click here. You can also listen online at JuiceboxPodcast.com, on Stitcher, iHeart Radio or in your favorite podcast app. Start at the beginning and take the journey with me, you'll catch up to subscribers in no time. The podcast is 100% free, I offset my costs by accepting ads on the show. It will never cost you anything to listen to the JBP.
If the podcast has helped you please consider leaving a comment below so that others may find the support they need to try an episode. #A1cYaLater #BoldwithInsulin #DiabetesandFear #TellAFriend
ESPN Commentator Speaks Ignorantly about Diabetes
ESPN commentator Stephan A. Smith apparently doesn't like Chicago Bears quarterback and person with type 1 diabetes, Jay Cutler
I'm not a guy who watches ESPN 24/7 but I do know that Stephen A. Smith has been in the center of more than a few controversies - probably by design. Normally we'd want to ignore people who say inflammatory sh*t just to get noticed but in this situation... maybe Stephen needs to hear from the diabetes community.
At some point in this clip Mr. Smith will say - speaking about Cutler - something to the effect of...
And I understand... they'll be people out there that say type 2 diabetes... the way I look at it we live in an advanced society where there is medicine everywhere to help you out.
Now I don't care if Jay Cutler is a good quarterback, nor do I expect for everyone to be a diabetes expert. But we should not allow someone with a platform like this to flippantly dismiss diabetes as if it were something that you take an Advil to clear up. Shouldn't we expect at the very minimum that if an ESPN employee is going to dismiss a serious diseases and the person who has it... Shouldn't that callous idiot at the very least, make sure that they are maligning the disease that the person actually has? I mean how difficult is it to find out that Jay Cutler has type 1 diabetes?
Stephen A. Smith should get himself educated, publicly set the record straight, and apologize on ESPN First Take where he made his ridiculous remarks. As for ESPN, maybe they should choose more carefully who they allow to speak on their behalf.
If you watch the video please start at the 4 minute mark. You do not want to suffer this blowhard for any longer than need be...
I'm just going to leave these links here along with a hashtag...
Stephen A. Smith - Twitter
ESPN - Twitter - Facebook
ESPN First Take - Twitter - Facebook