Diabetes Self-Management Blog

What if you could get all the benefits of metformin, but without the abdominal pain, diarrhea, gas, and vomiting that this medicine often brings? Well, such a treatment exists, and it works. Why hasn’t it come to market?

A group of enterprising osteopaths and pharmacists at Scarbrough Pharmaceutical Innovations, LLC, in Akron, Ohio, have patented a transdermal metformin (TDM) formula, or metformin that absorbs through the skin. The prescribed dose is squeezed out of a syringe and rubbed into the skin, although it could also be made into a skin patch. One of these osteopathic doctors, Jay Shubrook, DO, has been good enough to explain the issues to me.

TDM has the same benefits as oral metformin. It lowers insulin resistance, prevents dumping of glucose by the liver, encourages weight loss, and treats polycystic ovary syndrome (PCOS).

This could benefit millions of people. Whenever I or others write about metformin on this site, we get dozens of comments, equally divided between “This drug is wonderful,” and “This drug is awful. It tore up my stomach.” Many people can’t take it, or it makes their lives miserable.

The Ohio researchers prepared and tested a mix of four different “polymers,” or gels that can deliver metformin through the skin into the blood. According to their patent application,

One advantage of using transdermal metformin is its ability to bypass the gastrointestinal system. This allows the drug to not have the gastrointestinal side-effects associated with oral metformin.

Another unexpected benefit is that metformin seems to be absorbed through the skin much more effectively than through the digestive system. Apparently, 50% to 90% of oral metformin is degraded in the intestines and brings no benefit. According to research, a person taking 1500 milligrams (mg) per day of oral metformin can probably get the same benefit with a daily dose of 100 mg of TDM, delivered in two separate doses of 50 mg each.

So why isn’t this drug available? TDM’s inventors are “compounding pharmacists.” Food and Drug Administration (FDA) rules for compounding pharmacies forbid them from acting as manufacturers. They are only allowed to create compounds suited to an individual person’s needs, according to specific doctor’s order. They can’t make a product that any pharmacy can stock and provide.

Compounding pharmacists are extremely valuable. They can make drugs that corporate pharmaceutical companies don’t find profitable enough to make.

But these rules can cause strange situations. I used to take a multiple sclerosis drug called 4-AP that helped me walk better. It wasn’t FDA approved, but a compounding pharmacist could make it up with a doctor’s order, for about $12 a month.

Thousands of people benefited. Most doctors wouldn’t prescribe it, though. As with TDM, they hadn’t even heard of it. Finally, a drug company got involved and did the extensive safety and effectiveness research for drug approval. It’s now called Fampridine. Any neurologist will prescribe it, but it costs about $400 a month, so many people can no longer afford it!

The Ohio osteopaths have a patent on their TDM formula, but it’s not FDA approved. According to the FDA, “Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product.” Since there is no brand name TDM, it may be that some drug company will have to undertake the safety and efficacy research any new drug must go through. If that happens, TDM might become available, but only a long time from now, and at a very high cost.

Why should any of that be necessary, when we already know metformin is safe and effective? We’re just changing the route to protect our stomachs.

Most doctors know nothing about TDM, and many will be rightly concerned about not understanding the lower doses needed. Some will not take the time and effort to consult with a compounding pharmacist. But if you’re a person who hasn’t tolerated oral metformin, you might be able to find a doctor who will order TDM for you, and a pharmacist who will compound it. Unfortunately, since it’s not FDA approved, it probably won’t be covered by insurance. People I have talked to are paying about $60 a month for two doses a day.

At this point, no drug company is likely to take on the expense and effort to get TDM approved. The profit margins aren’t high enough. The Ohio pharmacists are working on it; so might be a company in India, but with their lack of resources, it will take many years to get approval, if they ever do.

I think it’s up to us to demand that FDA fast-track TDM. We should write to the American Diabetes Association, the FDA, the PCOS Foundation, the American Association of Clinical Endocrinologists, and everyone else we can think of, demanding that resources be put into this drug, which we already know works and which could save millions from misery.

If you want TDM now, find a compounding pharmacy that will make it up for you, like Scarbrough Pharmacy in Ohio (the inventors.) Or someone closer to home. Then talk to your doctor about ordering it.

If desired, the pharmacist will work with your doctor. Dr. Shubrook says “We look at the clinical glucose response. We order a comprehensive metabolic profile as well but have never seen problems with this.”

Roughly 100 to 200 mg a day in divided doses might be a good place to start, but ask your doctor about that, after showing him some of the papers linked in this article.

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Comments
  1. The reason why this new metformin isn’t on the market is that obscene agency called the FDA, they work for the Pharma industry and not for the American people.

    Posted by Jim Crosby |
  2. What an exciting article! I am thrilled to know there are options out there for those of us who have chronic nausea and other Metformin side-effects.

    I’m checking ASAP to see if my pharmacy could fill the bill.

    Thanks!!

    Posted by Mary Thompson |
  3. I have been suffering the gastrointestinal effects of Metformin for year.

    Thank God I may now have an effective alternative!

    Posted by Bill Kisse |
  4. i am on metformin an i have all the stomach problems you named. i sure would like to find out if that can of metformin would help me.

    Posted by priscilla notyh |
  5. I don’t suffer any side effects that I’m aware nor has it ever seemed to do much even in the onset of my Type II diabetes some 12 yrs ago.
    A new delivery system might just prove to be more effective for all of us.

    Posted by Dave A |
  6. is there any indication that this method of application would lower the risk to we folks with slight to moderate kidney damage. as you know this drug is not to be used in our situation as currently taken.

    Posted by eugene cimis |
  7. I am Type 2 Diabetic who was taking metformin 1000MG tab.
    Because of the bad side effects my Dr had me take 1/2 tab daily, but my blood glucose levels went up. I no have to take a shot, I take Lantus insulin, I have been doing this now for a week and a half and I still do not have my blood sugar levels down. Running between 300-400, this scares me. It would be nice for me to get this rub, so please tell me how?

    Posted by Sara |
  8. So happy I didn’t miss this article. You would never believe what I went through for over a year. Finally, after many tests and working with the endo. and gastro Drs. discovered I couldn’t tolerate Metformin. Am now taking 4 shots of insulin a day and would love to try this new product. Hopefully it will become available before I am too old to benefit from it. (78 on 12/31/12 and still going strong) but how I would love to get off shots. Thanks for the info.

    Posted by Carol J. Hinds |
  9. I have been on Metformin for almost 5 years. I was miserable until I switched to the extended release, which has been a godsend for me. I learned about it from my pharmacist who also takes Metformin - no doctor has ever offered it. This may be an option for people who can’t wait or have restrictive insurance.

    Posted by Teresa |
  10. I am still on Metformin with the side effects but this article is both encouraging and discouraging. I’m afraid if this becomes available it will be so expensive many will not be able to afford it. I have Rx insurance but they will only insure certain drugs and if only one works but is not on their list they will not pay for it. There will soon be more control over our medical bills so I’m not going to get too excited yet.

    Posted by Ferne |
  11. i take metformin in the morning, but at night it make my belly roll over, so that good news.

    Posted by yvonne burrell |
  12. The FDA should be here to protect us against bad drugs……here is yet another case of the FDA demonstrating that they work for drug companies….this needs to stop.

    Posted by Patti |
  13. Thank you for posting this! I am prescribed 1000mg of metformin daily. Combined with glipizide, this dosage is effective in keeping glucose levels down but I suffer from often embarrassing side effects as described.My employment keeps me in front of the public and TDM may be just the solution I’ve been searching for for 5 yrs +. Thanks also for letting us know the entities to write,I for one, would like to see it fast-tracked.

    Posted by Jay Proetto |
  14. Have been able to circumvent the gastro problem and diarrhea by taking Janumet.
    However it is expensive.
    I wonder what the cost would be for metformin via a patch. HM

    Posted by H Molvang |
  15. Another factor against TDM is the low cost of metformin. Under my new medicare advantage plan, I can actually get the metformin for free if I order it through the bulk supplier.

    Posted by cm |
  16. i was on metformin and I ended up having to go to a kidney specilist, my kidey functions went down due to the metformin. Now that I am off Kidney funtions are back to normal. Unfortnatly I have hd to start levimer {insulin} to help control the blood sugers along with onglza, diet and exercize.
    The dose of the inslin is being decreased which is good. Been a very hard road for me and I know I have a long way to go. Metformin was not for me

    Allen

    Posted by Allen Lawrernce |
  17. Excellent article. Thanks for the education!

    Posted by Cheryl |
  18. I would love to have the patches rather than taking those horse pills(I call them) which sometimes make me want to throw up. The gas that comes along I wish i could use in my vehicle

    Posted by Alloysia Haynes |
  19. Every drug we take orally goes through the gastrointestinal system. I do not have any side effects from taking 1000 mg of metformin twice a day. However, would it be better not to have this medication go through my entire body every day? I am wondering what the long term effects of this oral medicine are compared to a TDM bypassing all organs. TDMs sound better to me. Oh but, of course, we can take another pill for those other complications. And the pharmacies keep on making money.

    Posted by Jan |
  20. I have been on metformin for 2 years now and have major problems with stomach pain and diarrhea.
    I can’t leave the house untill the diarrhea stops,
    that’s a pain in the butt in more ways then one.
    I look forward to taking this article in to my doctor.

    Posted by susan spandel |
  21. I have taken metformin years ago but now, I take insulin. Yes, metformin not only have given me stomach problems but it gave me diarrhea. Other side effect of this drug is a sudden drop in blood sugar. Even though, I have eaten food before taking the medication, I had blacked out at the steering wheel while driving my car on the highway. Luckily, no one was injured including myself. Note! Use metformin with caution, especially operating a motor vehicle.

    Posted by Kim K |
  22. So far I have not had any side effects from taking 1000 mg of metformin twice a day. It is still not working to bring my sugar down. The doctor suggested my taking Janumet. I am suppose to take this like metformin twice a day too. Does anyone know what the side effects are with this drug.

    Posted by Emilie |
  23. Metformin all most killed me. Did you know if you take a water pill like lasix it doubles the dose. I had 2 emergency CT scans & 1 MRI trying to find what was wrong with me. The manufacture told me to stop metformin now.
    After the ct scans & mri. I figured out the problem myself, it was metformin causing interaction with my other meds. It took 1&1/2 month to get it out of my system, so I was not on on any diabetc meds for 1-1/2 months.
    I am fine now and taking januvia.
    The manufacture did think my pain, testing etc. was worth anything.
    Since this happened to me I have talked with 7 other people having problems with metformin and their dr. changed their meds for diabetes. So be be careful if you take metformin.

    Posted by Karin Eleczko |
  24. I guess I am one of the lucky ones. I have been taking metformin, (now at 2 1000mg tablets a day), for 20 years with zero side effects and it is still quite effective. I also take glimepride twice daily and the combination works well for me after all those years.

    For those not so lucky I am glad to see a new delivery system that may make it easier for them to take metformin.

    Posted by Bob |
  25. i’ve been taking metformin for a few years. i told my doctor about the diarrea several times. the last time i told him about this problem, he asked me how long this has been happening? i told him several times i won’t take metformin when i have to go somewhere. i can’t even make a five minute drive to the post office without a problem. so this has cut me off from going to my quilt club.is this healthy for people? dosn’t this cause dehydration? so as long as i take this stuff, i have to stay at home. good luck everyone.

    Posted by darlene good |
  26. Thanks for this great post! I am prescribed Metformin ER at 2000mg per day in two doses. There’s no argument that it really works controlling my glucose and allows me to cut back radically on the insulin and managing my glucose and A1C much better. The problem is the gastro side effects and nausea. At times it’s made me so sick that I can’t function, either at work or at home. As I write this I’ve been off of it for 3 weeks due to other gastro problems. A transdermal delivery method for this is a Godsend for a whole lot of us. I talked to a local compounding pharmacy in Pensacola, Florida, Pensacola Apothecary, and they told me that they have a TDM formula, although not the particular one mentioned in the article. I passed along this link to them so that they can be prepared to get my prescription!!!!

    Posted by Alan |
  27. I have been on metformin for about 10 years and it did help with my PCOS. I was able to get pregnant after many years of trying.

    Posted by Gracie |
  28. Metformin does cause a small percentage of people to have abdominal distress especialyif they eat excess sugars and starches. Dropping the dose to 500 mg twice daily and consistently taking it after meals cures the vast majority of patients–the 2000 mg/day dose only decreases your A1C by 0.3%–hardly a significant number. Metformin in the generic form is free in most states at Kroger and Publix pharmacies. Yes FREE. In the tiny percent if patients who still cannot tolerate metformin Glumetza will work. This costs $10 with a coupon from your MD if you have insurance, otherwise patient assistance will need to be explored. The compounded drugs are usually not approved because they have not been tested or have been tested and found lacking. The FDA has its problems, but they never let Thalidomide in to the US. If you can afford the compounded products, have at it!

    Posted by David Bramm |
  29. WOW, I sure could benefit from this drug. Ever since taking Metformin, my mornings are a living hell….I can’t seem to stay out of the bathroom. Cannot do anything in the mornings. So, why is the FDA so opposed to something that could benefit so many?? I could not afford to purchase this through a compound pharmacy even though it might cure my problem. I have been going through this for 2 years now and it is no fun!!

    Posted by Carol l. |
  30. I have been on Metformin for 2 years now and I suffer from gastrointestinal pain and constant diarrhea that requires resting and a heating pad. This meds sounds wonderful, but too expensive for me.

    Posted by Carol l. |
  31. I would like to correct a misconception that Jan and many other Americans believe. PHARMACIES don’t make all the money from drug sales. Pharmacies are the low man on the totem pole and the ones you should have issues with are the Drug
    Companies. Our reimbursements from insurance (which the drug companies own) is at an all time low, forcing many independent pharmacies to close. Gone are the days when we could make money in the pharmacy business. So don’t blame your pharmacy for the high drug prices. Its not us, its the rich drug companies.

    Posted by Valerie |
  32. I have not seen any indication that transdermal metformin would be easier or harder on the kidneys than the oral kind. We probably won’t know until the drug has been in wide use for a few years, if that ever happens.

    Posted by David Spero RN |
  33. Good afternoon: Your article must have come at a good time in my life as I was able to: 1. Read the entire article and make sense of it; 2. Discuss the accompanying patent application with a physician, and 3. Cause to have dispensed a preparation of the Trans Dermal Delivery System for topical application of Metformin (two pumps = 100 mg of Metformin, applied per day - once in the morning and once in the evening…12 hours apart.) I have been on this schedule for three days now, after discontinuing oral Metformin (850 mg, two times a day). I still take my Januvia (100 mg in the morning - once a day) and so far the results have been encouraging. My blood sugar readings have not gone above 160, or below 110, with no gastrointestinal distress. I have been diabetic for more than 25 years, am 5 ft 6 inches tall and weigh 133 lbs. I have maintained this weight for more than 20 years - having initially lost 40 lbs - no more than 1/2 lb. per month and walk 3-5 times a week. I concomitantly began a gluten-free eating program so, I cannot attest to the influence of either (trans dermal metformin) or gluten-free diet, but suffice it to say, I am very pleased with my current status, and will continue to report on the progress of my “experiment,” in the future. If the trans dermal delivery system continues to perform well, trying this this novel delivery system in type 2 diabetics should be included in physicians’ armamentarium by medical practitioners who care for diabetic patients like me. Thank you for listening, and I hope to hear from you. Best, RBYoshioka, Ph.D.

    Posted by Robert Yoshioka |
  34. Sorry to be so late with this comment - just catching up on these newsletters.
    Please do not paint the FDA as so evil. They are trying to protect us from dangerous or mis-labeled products. This transdermal delivery system is very complex. It needs much research to prove that the amout delivered is consistent. Patches frequentlycause a host of other problems - skin irritation, allergic reactions, etc. These processes add to the cost of approved products. David, you would be the first to want to sue the FDA if they approved a product that did not perform to your high expectations. The metformin absorbed would have the same degree of blood glucose lowering. Most diabetes cannot be controlled by metformin alone, so those complaining about using insulin should know that they probably would still need insulin to control their blood glucose.
    Put yourselves in the FDA position. Pharmaceutical companies complain when you are cautious and demand more data and the public complains when you don’t approve some miracle drug immediately. remember the thalidomide scare and thank your lucky stars that we have someone protecting us from “miracle” cures.

    Posted by Pharmacist Linda |
  35. Iam using Gluconrom G4 forte for two years
    and iam suffering from diarrhea. Is their any
    other substitute without metformin combination
    to control the diabities

    Posted by Sudhir K |
  36. Hi Sudhir,

    Gluconrom isn’t metformin. It’s a “metaglinide,” a drug that stimulates insulin production for an hour or two after you take it. Diarrhea is a known side effect of the drug, as is hypoglycemia and weight gain.

    Did you and your doctor already try metformin? If that didn’t work, you can try harder on your diet (see my article on reversing Type 2) and/or look into one of the newer incretin drugs like Byetta or Januvia.

    Posted by David Spero RN |
  37. I have been using the TDM for about a year now,and I
    no longer experience any of the terrible side effects. My A1C went from 7.0 to 6.4 in 6 months. It’s great!!

    Posted by Sue |
  38. This sounds like a great solution. I am taking Jentadueto, which is 5 mg of linagliptin and 1700 mg of metformin and I am having alot of stomach problems. I have been calling around to compound pharmacies in my area and can’t seem to find one that is familiar with TDM. Do you know of any in the Baltimore Washington area?

    Posted by Joanne Bauman |
  39. Joanne,

    I don’t know pharmacies in the Baltimore area, but many compounding pharmacies will mail meds to you.

    David

    Posted by David Spero RN |

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