February 1, 2023

Thanks to Sugar High subscriber Michelle for a great question about the latest round of recalls on the Type 2 Diabetes medication metformin. Extended release metformin has been subject to several recalls over the past year due to contamination with a probable human carcinogen called NDMA. In this video, PA David explains what’s going on, what the risk is, and what to do if your supply of metformin is affected by the recalls.

So metformin got recalled again what’s up guys welcome to another sugar high answering your questions video this time from my office i normally do these in my backyard just because i like to keep these kind of videos more casual and more conversational just kind of winging it just between you and me uh but the days are getting shorter and by the time i get home

There will be no light left so we’re stuck here in my office if we’re going to get this done so welcome to where i work uh if you’re new to sugar high my name is pa david i’m a board certified and licensed diabetes specialty pa i work in upper los angeles uh county area and these types of videos are where we get to talk back and forth i love it when you guys post

Questions and comments on my videos because number one it helps me to know that this information is actually getting out there to somebody and that’s really encouraging but the fact that you guys are thinking about your diabetes and wanting to know more about it and get clarity from the information that’s out there is really encouraging and it makes me excited to

See how well you guys are doing on one of my recent videos i got a question from a sugar high subscriber named michelle that says could you please do a video about the second round of metformin recalls cvs told me that my pills were not part of the bunch but i’ve stopped taking them for the last two weeks and my a1c is already starting to creep up she mentioned that

She usually runs about 5.8 and she was creeping up to about six in that same comment she also asks about the ada recommendation of 7.0 being the goal for an a1c reduction and i’m going to address that in a different video i wanted to speak mostly about the recall in this one i am planning a whole video about what a1c goals ought to be and where the guidelines

Really come from and i think that that kind of warrants its own conversation so we’ll cover that later but in in regard to michelle’s question about the recall let’s talk about that by the way michelle actually has a youtube channel of her own that you should probably go check out it’s called tasting positive and it’s kind of interesting because in that channel

She’ll share some of her own insights and lifestyle tips in regard to her own experiences with diabetes and she has a very interesting type of diabetes called modi that she’ll share with you a little bit more about and if you want to know the scientific aspect of what modi is this video will kind of explain that um but check her out for sure i’ll put a link to her

Channel in the description of this video so let’s talk a little bit about what is going on with this more recent recall that happened turns out this isn’t actually anything new as much as it is an extension of an ongoing set of recalls that have been going on since earlier this spring i actually covered this recall in a separate news flash video on this channel

Back in may when it first happened so here’s the whole story metformin is a generic drug which means that it’s not protected by patent and any pharmaceutical company can make it when a medication is first produced it has a 17-year patent life where only one company the company that developed the medication is allowed to make it but then after that it goes generic

And pretty much anybody can make it so usually there’s no problem at all when multiple different companies make a generic version of a pill it’s the same medication but just in different shapes or different sizes and it’s it all works out fine but once in a while little impurities can end up in these pills so the medication itself is fine so that’s an important

Factor to remember this is not a problem with metformin metformin’s fine it’s that a couple of companies that make metformin when they were putting it into pill form accidentally included this additional contaminant called ndma okay now that’s not mdma like ecstasy can you imagine if this was ecstasy people would be lining up out the door for metformin right

But this is ndma which is sort of like this byproduct chemical that gets created in all sorts of different industrial processes according to the environmental protection agency ndma is a commonly produced accidental byproduct of all sorts of different chemical and industrial processes it’s been found in drinking water it’s been found as a contaminated medication

It’s been found when they make tires i mean all sorts of different applications in industry can result in the accidental production of ndma but what it’s not is something that’s ever made on purpose it’s sort of just this byproduct that formation of chemicals can sometimes result in causing and in this case the fda hasn’t fully identified what the source of the

Production of ndma was so if a tiny bit of ndma gets into your medication why should we really care well in animal studies ndma has been found to increase the risk of cancers there’s not been an actual human study because of what they learned in animals but it’s assumed that because it causes cancers in animals that it probably causes cancers in humans as well

But what they do know is that it would take a very high amount of ndma over a long period of time to really cause cancer a small amount over a short period of time is not that big of a risk not saying that you should go out and voluntarily try it but if you accidentally get some here and there in some medication it’s not the end of the world back in december

The fda announced that certain metformin tablets were found to have small amounts of mdma in the pills but they determined that it was such a small amount that it was not really worth doing anything about it they didn’t actually launch any kind of recall they just said you know we found this guy’s be careful it’s not enough to harm anybody but let’s not keep

Doing this okay we’ll fast forward to may of this past year where five different manufacturers were found to have much higher concentrations of ndma in their metformin pills and in that recall it was specifically 500 milligram metformin extended release tablets no other formulation of metformin was affected then by july seven more companies issued voluntary

Recalls as a result of this may announcement drug companies started looking at their own metformin they’re like oh god we’ve got some ndma in there too so they issued their own voluntary recalls another company was added to the list in august and then just this past month two more companies one called sun pharmaceuticals and another one called mark sands both

Issued voluntary recalls that their metformin also had unacceptable amounts of ndma in their pills so currently affected are certain lots from those specific companies of 500 milligram and now 750 milligram tablets of metformin but again still just the extended release version what’s not included in this if you’re on a thousand milligram pill of metformin that

Is not part of this if you’re on an immediate release metformin that is not part of this if you take a combination medication where the metformin is combined with another medication like genut for example where it’s genuvia plus metformin combined into the same pill that’s not part of this if you take invocamet where it’s in volcano and metformin combined into

The same pill that’s not part of this okay any kind of metformin plus another pill is not included in the recall so you don’t have to worry if that’s the type of metformin that you take so now that we know what’s part of this let’s talk about what to do first thing is don’t panic on the fda statement where they announced this recall they said in that statement

People who are taking medications that are part of this recall should continue taking those medications until their doctor or pharmacy has replaced them with another medication so don’t feel like you have to immediately stop taking your pills because the risk of your diabetes going out of control is a greater threat to you than the small amount of ndma that is

In these pills again i’m not saying that you should go out and take ndma for the rest of your life that would not be good for you but in the short term context the greater threat is actually going to come from your diabetes so keep taking your medications call your pharmacy if you’re taking extended release 500 milligram or extended release 750 milligram tablets

Of metformin and say hey i’m taking metformin can you please tell me if my pills were affected by the recalls and they have documentation of the lot numbers that your bottle of metformin came from and they’ll be able to check it against the listed lot numbers and tell you you’re fine or hey come on bring them back in we’ll get you some new metformin all they

Really got to do is get you another bottle of metformin from a different manufacturer that’s not part of this recall and you should be just fine another option is calling your doctor and if your healthcare provider chooses to change metformin to something else altogether that’s also a perfectly acceptable option but what you don’t need to do is panic it’s okay

To keep taking your medications it’s better to keep control over your diabetes because if that’s the greater threat to you than a small amount of contaminant you got to keep the big picture in mind here i hope that that was a fair and helpful explanation of what’s going on here and maybe gives you guys a little bit more insight into the best way to move forward

I don’t like to minimize concerns but i also like to keep context of what threats really are when threats do arise so stay healthy sugar high if you enjoyed this video or found it helpful do me a favor click subscribe click like there’s a lot of information on sugar high that i really hope that you’ll find helpful and enjoyable and i’ll plan on seeing you guys in the next video you

Transcribed from video
Metformin Recalled Again! Diabetes Specialty PA Explains. Answering Your Questions – Edition 3 By Sugar High