Would you believe … a triamterene shortage

(Updated May 19, 2013)
Talk about shocked and surprised. I was at the pharmacy today to pick up a couple of prescriptions and was told that the generic form of Dyazide (a diuretic or so-called “water pill”) was on back order. It seems there’s a shortage of its two active ingredients, triamterene and hydrocholorothiazide.

A shortage? Of a generic drug that’s been handed out like candy for as long as I can remember? That’s been so cheap that it’s hardly worth a pharmacist’s time to bottle and label it?

Apparently this has been going on for several months and I’d been unaware of it until I had to get a refill. The only “explanation” I could find online was posted May 3: “Mylan and Sandoz could not provide a reason for the shortage.” (Apparently those are the only two manufacturers of the drug.)

“No reason”? Come on. Of course there’s a reason; they just don’t want to tell us. One of the most common long-standing drugs on the market doesn’t just disappear. Was there a recall the pharmaceutical companies don’t want to discuss? Were they cited for contamination in their manufacturing process? Did some overseas source dry up unexpectedly? Maybe their Chinese pill plant was destroyed in an earthquake. Or maybe they sold out to the 10,000 opportunists now hawking the drug (most likely fake) online.

Actually, my first thought was that they’re trying to drive up the price. That tells you what I think of Big Pharma. Or maybe they’re just laying the groundwork for the introduction of a new and better diuretic — with a brand spankin’ new patent of course, and therefore much more expensive for us and profitable for them.

UPDATE: On May 30, 2011, Medical News Today reported one pharmacist’s opinion about drug shortages in general:

… the recent global economic crisis has affected drug supplies. When the economy is tight pharmaceutical companies tend to drop production of the least money making drugs. If there are generic products available, some drug companies simply stop making their brand products.

UPDATE, JULY 13, 2011: Just came across a brief CNN report on hospital drug shortages.

UPDATE, JULY 14, 2011: I continue to get a lot of hits on this post and have continued to try to find information. Today in the FDA “Enforcement Report for February 2, 2011,” I found this item:

Product
Triamterene and Hydrochlorothiazide Capsules, USP, 50 mg / 25 mg, 100 Capsules, Rx only, NDC 0781-2715-01. Recall # D-204-2011
Code
Lot #: 172570, Exp 12/10; 176302, Exp 05/11; 178590, Exp 06/11; 179318, Exp 08/11; 180013, Exp 10/11; 181796, Exp 12/11; 183307, Exp 02/12; 184758, Exp 04/12; 187339, Exp 06/12; 188628, Exp 08/12; 190119, Exp 10/12; 191984, Exp 02/13; 194254, 196706, 197756, Exp03/13; 198604, Exp 07/13
Recalling Firm/Manufacturer
Sandoz Inc., Broomfield, CO, by letters on November 18, 2010 and January 19, 2011. Firm initiated recall is ongoing.
Reason
CGMP Deviations; Firm reported use of a blender with a slightly different inside geometry than the blender used during process validation. Using a blender that has not been validated indicates CGMP deviations.
Volume of Product in Commerce
515,466 bottles
Distribution
Nationwide

The FDA “Enforcement Report for April 6, 2011” includes this entry:

Product
Triamterene and Hydrochlorothiazide Tablets, USP, 75mg/50mg, Rx only 500 Tablets. NDC 0781-1008-05. Recall # D-413-2011
Code
Lot 192733 Exp. 02/13
Recalling Firm/Manufacturer
Sandoz Inc., Broomfield, CO, by letter on November 18, 2010. Firm initiated recall is ongoing.
Reason
CGMP Deviations: the firm states that the root cause is related to an event that occurred during the compression process for the batch.
Volume of Product in Commerce
5427 / 500 count bottles
Distribution
Nationwide

“CGMP” stands for Current Good Manufacturing Practice.

It seems Sandoz discovered and reported on November 18, 2010, that a blender being used to manufacture triamterene/HCTZ differed slightly from the one approved by the FDA. Such a deviation is not allowed, so Sandoz initiated the recall itself. The second report refers to a different problem, an unidentified event that occurred during the compression process. Note the first recall was of capsules, the second involved tablets.

In addition to the FDA reports, the ASHP updates their reports periodically.  (I suggest readers check this link for the latest information.)

On June 29, 2011, it stated the following:

Reason for the Shortage

  • GSK, Watson, and UDL could not provide a reason for the shortage.
  • Mylan stated the shortage is due to increased demand for the product.
  • Sandoz stated the shortage is due to a raw material shortage and capacity issues.

Estimated Resupply Dates

  • Mylan has triamterene and hydrochlorothiazide 37.5 mg/25 mg capsules on back order and the company cannot estimate a release date. The 37.5 mg/25 mg and 75 mg/50 mg tablets are also on back order and the company estimates a release date of mid-July, 2011. Mylan has Maxzide 37.5 mg/25 mg (NDC 00378-0464-01) and 75 mg/50 mg (NDC 00378-0460-01) tablets available.
  • Sandoz has all triamterene and hydrochlorothiazide capsules and tablets on back order and the company is shipping partial releases every other week.
  • UDL has available triamterene and hydrochlorothiazide 75 mg/50 mg unit dose tablets in 100 count packages (NDC 51079-0433-20). The company is shipping partial releases of the 37.5 mg/25 mg capsules as product becomes available.
  • GSK has Dyazide 37.5 mg/25 mg capsules on back order and the company estimates a release date of mid-July, 2011.
  • Watson has triamterene and hydrochlorothiazide 75 mg/50 mg 100 count tablets (NDC 00591-0348-01) and 500 count tablets (NDC 00591-0348-05) on allocation. The triamterene and hydrochlorothiazide 37.5mg/25 mg 100 count tablets (NDC 00591-0424-01) and 500 count tablets (NDC 00591-0424-05) are also on allocation.

UPDATE, JULY 22, 2011:  Picked up a refill today and am happy to report it was the 37.5/25 mg tablet I’m supposed to have. And it’s from Sandoz. The pharmacist said supplies are improving and they are no longer having any problems filling their prescriptions. I’m in the Denver area and use the CVS pharmacy in my supermarket. I hope this is true for the rest of the country as well.

UPDATE: AUGUST 8, 2011: NBC ran a story on drug shortages today. It did not mention triamterene specifically.

UPDATE: MAY 27, 2012: The tablets can be cut with a pill cutter if you can only obtain tablets that are twice your usual dosage. You can usually save money by doing this, too. Capsules can be cut too, but they contain a powder that will spill, so maintaining the proper amount in each half gets tricky. Capsules and tablets are interchangeable as long as the dosages are the same. The most important thing to do if you can’t get the tablet or capsule you are used to is to talk to your doctor. He or she can reassure you as to what is the right thing to take.

.

Also on Pied Type:

Health reform: Big Pharma escaping again

More on Big Pharma’s Ethics

Obama sells out to Big Pharma

Wyeth chooses profits over ethics

Polypill no panacea

Believe it: Vytorin is all about Big Pharma reaping profits



Categories: Big Pharma, generic drugs, Health

Tags: , , ,

34 replies

  1. I was told the same thing. And the new drug that they have given me, Maxzide, is making me sooo sleepy that I can’t keep my eyes open. I am looking for information on why the shortage on the triamterene. Have you found out anything else on this? I would greatly appreciate additional informaition.

    Thanks!

    • I’d like more info too. That one ASHP note was all I could find about it. Everything else appeared to be sites selling the stuff online. I find the lack of information very strange, almost conspiratorial.

    • Now is 2013, again there is shortage of triamterene, Maxzide which I have been on for many years. There is no explanation given by the pharmaceutic companies for the shortage, nor is there an expected date for availability. No regulatory agency knows anything about the current shortage either.
      Could someone who experienced this shortage in 2011 or current shortage let me know what alternatives do I have to survive this shortage crisis? thank you for kind reply. Kay

  2. It could be any of the reasons you mentioned in your post. Believe me, it drives pharmacists up the wall, too. I’ve actually written about shortages for ASHP, the group you linked to. http://www.ashpintersections.org/2010/12/pharmacists-successfully-managing-drug-shortages/

    In other news, you don’t get charlie horses from that drug? My old doc used to prescribe it for monthly, pre-menstrual water retention, and about three days of that was all I could take. I’d get the most horrible cramps in my calves and feet. More power to ya if you can handle it, because it’s good at what it does.

    • I figured you’d know about this if anyone did. I’m not satisfied with “no explanation,” but it seems I’m stuck with it. You don’t get a byline for stories like that? Sure makes it hard, later, to show it in a portfolio and say you wrote it. I had the same problem when virtually none of my in-house writing had a byline. My name was on the masthead, but that didn’t prove anything.

      I’m guessing your leg cramps were because the drug strips a lot of potassium. Doctors often tell me to drink a lot of orange juice with it to compensate.

      • Update: The pharmacy was able to get some pills that are double my prescribed strength. They had to get my doctor’s permission to dispense them (probably to make sure I’m responsible enough to follow instructions!), and I’ll have to cut them in half to get the proper dose.

  3. I’m glad to see this post. My pharmacist told me the triamterene/hctz is back ordered, my doctor’s office said they had stopped manufacturing it. I take it to help with my vertigo and there aren’t alot of good options pill wise for me. I’m fascinated why I can’t seem to find practically any information at all. I was thinking all the things that you wrote about.

  4. Thanks for posting this information. I just got a refill, and was up against the same problem: no pills in my strength. They gave me the double-strength but since the pharmacy computers wouldn’t process it, they had to change my prescription, too. They said that they will change it back when they get the smaller dose back in, but I’m not sure if they will.

    This is a recipe for overdoses, isn’t it? And what happens if there is none next month? My pharmacy won’t allow me to buy my medicine in advance. Grrrrr… I hate Big Pharma.

    • Check with your doctor, your pharmacy, and your insurance company. You may be able to get your prescription changed to a three-month supply. I did, and it’s certainly more convenient.

      Yes, I thought I’d easily remember to break the tablets in half, since I already do so with another med. I’d almost swallowed a whole one before I remembered. Stopped right then and broke them all in half. Ugh. They’re a lot harder to swallow with corners and rough edges.

  5. Just got back from Target and also was told no Triam/HCTZ 75-50mg. I do get a three month supply and typically use mail order via insurance but hate dealing with them! They called my dr. who switched me to Spirono/HCTZ 25/25 (gen. for Aldactazide) which was $30 rather than a $10 copay. I stupidly asked if there was a generic on this and the pharmacist (yes the pharmacist) said no, sorry. She also had no explanation for the shortage, no idea if it was a potential recall issue and no explanation for why I was not consulted before they called my doctor and changed my meds!!! As I left Target I wondered what was going on. When I got home I realized this is a generic so now am wondering whether the pharmacist was really a pharmacist or a tech. A bit too Twight Zone for me! I usually use Walmart or CVS but a few months ago had those darn transfer a script and get $10 Traget cards coupons 🙂

    • If you have any doubts at all about the drug you were given or the person who gave it to you, call them for an explanation. I’m surprised they didn’t at least explain to you that they were giving you a different drug but had called your doctor for approval before doing so. You might also want to double check with your doctor, and tell him/her that you’d like to be called/consulted the next time they change your meds for any reason.

    • I too take the generic dyazide from Mylan who gets its supply from SANDOZ. Since the shortage started my intuitive voice has been telling me this is not the same chemical make up in the little green and yellow capsule that I used to get before the recall. I noticed a difference right away with the white and black striped capsule during the waiting period for the green and yellow capsule. My return to the green and yellow capsule (as of 2011) have the same negative results for me as the white/black capsules. When complaining to my pharmacist they would only say it was the same ingredient. I am so unsatisfied with what I am starting to notice as negative side effects that are becoming more prominent that I am going to ask that my current prescription capsules be diagnosed for ingredient content.

  6. When i first went for a refill for the generic, Triamt/Hctz I was told the previous ones were no longer available. Then when I needed a new refill I found this one to be different also. they said the previous one was also unavailable. After taking these piills for over 20 years ( one a day ) I never thought the dosage changed and i was not informed any differently by the pharmasist, and I was unaware that they had called my Dr. to make the change.
    Needless to say I didn’t read the bottle as it was always the same dose. I was taking a double dose for about a month and found myself feeling terrible. I was tired, spacey, unsteady & loss of appetite. I still don’t feel well even though I had a change in medication. I called Walmart when I felt it had somethig to do with my pressure And checked the bottle, only to find I was to take a half Pill instead of a whole one. All I got was an apology for not informing me and an offer for a free refill. I called Mylan and Sandoz and got no satisfaction.
    I just found that there was a recall but can’t find much info. Does anyone know about this ?

  7. I tried to refill my prescription for triamterene 37.5 mg/HCTZ 25 mg. today, and was told the pharmacy
    couldn’t get it. I take it for blood pressure, not premenstrual problems, so it is critical for me. I’ve been
    taking it for years. I’m sure the pharmaceutical companies are trying to drive the price up or trying to
    force us to use newer meds that are still under patent. Whatever is the cause, and yes, I saw the NBC news about it tonight, I’m sick of the outright greed in this country. Aren’t these mega corporations rich enough? (I worked for one of the largest pharmaceutical companies in the world before I retired). I’m disgusted with Wall St., the heads of these huge conglomerates, and politicians. It won’t surprise me if we wind up in another ‘French’ revolution before it’s over.

  8. I just tried to refill my prescription today and the pharmacy informed me that its no longer on the market. Great.

    • I’d double check that. Make sure they are aware there’s a shortage. Ask if they checked around. And check around with other local pharmacies. As it happens, I just refilled my prescription yesterday — with no problem. It’s a generic 37.5-25 mg tablet (green) manufactured by Sandoz.

  9. I’m getting it today! Since May I had to substitute another diuretic that was NOT potassium-sparing like triamterene. I suffered foot, toe, ankle and calf cramps (charlie horses) all night (15 times), every night. I tried drinking tons of OJ, quinine, ate bananas, apricots, etc. to no avail. As soon as I stopped taking the drug, the cramps stopped.
    I was asking my dr. to prescribe a different potassium-sparing drug such as amiloride or spironolactone- but then I called my pharmacy to see if triamterene is now available – and YES!

  10. I had been taking the triamterene 37.5 mg/HCTZ 25 mg. capsules for about 4 years when suddenly they were unavailable. I was given the green tablet in it’s place which I have taken now for the last 5 months. I have to say that the tablets do not seem to be as effective as the capsules, at least for me. The swelling that I experience in my ankles doesn’t seem to completely subside overnight like it used to with the capsules. According to my Walgreen’s pharmacist, the capsules are not being manufactured anymore. 😦

    • i also had been on triamterene capsules for about 5 months for swelling in my ankles. my doctors could not find a reason for the swelling (heart,etc) and prescribed the capsules. the swelling went completely away and i felt great. then i went for a refill and was given the tablets. they do not work as well and i am back to having swollen ankles. we even increased the dose to two 37.5 mg a day and that has not changed anything except now i need to have blood work checked more often. did you find an answer to this problem????

  11. My 37 year old son was given triamterene 37.5 mg / HCTZ 25 mg capsules for Menieres; immediately he had psychotic episodes and seizures; unfortunately it took us almost 2 years to figure this out. Now he has side effects even though he no longer takes this medicine. Has anyone else had this reaction? We have had almost 2 1/2 years of living hell.

  12. I have taken triamterene 75/50 for many, many years and paid about $4.00 for a 90 day supply from my mail order pharmacy. All of a sudden my last refill in June 2012 cost me $19.00 for a 90 day supply. I called the pharmacy and they just said that they cost had increased so they had to increase my cost. I think it’s a ripoff for consumers.

  13. I’d been taking 1/2 of the 37.5/25 per day for years and it worked very well in conjunction with another BP pill. My mail order provider Medco has said it is on back order from Sandoz. They also mentioned something about capsules only instead of tablets which presents a problem cutting the dose in half. I agree with others that the cause is probably is about the low cost and margin. The unfettered greed of corporations and CEOs is going to destroy the USA and the world. If the price isn’t high enough then they reduce supply and drive up prices. The oil companies aren’t the only ones that will finagle supply and demand to increase profits.

  14. It seems to be happening again, started about January 2014, it’s now mid March.

  15. This whole triamterene shortage thing was tied into the problems with a company called Novartis. They made generic drugs for Sandoz, including triameterene. The only reason I found out was because I was researching why Maalox is no longer available on the market. Novartis in Lincoln Nebraska is closed until further notice. Weird! I too went for several months having to take the non generic dyazide at 3 times the price because of the so called shortage.

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