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:
Triamterene and Hydrochlorothiazide Capsules, USP, 50 mg / 25 mg, 100 Capsules, Rx only, NDC 0781-2715-01. Recall # D-204-2011
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
Sandoz Inc., Broomfield, CO, by letters on November 18, 2010 and January 19, 2011. Firm initiated recall is ongoing.
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
The FDA “Enforcement Report for April 6, 2011” includes this entry:
Triamterene and Hydrochlorothiazide Tablets, USP, 75mg/50mg, Rx only 500 Tablets. NDC 0781-1008-05. Recall # D-413-2011
Lot 192733 Exp. 02/13
Sandoz Inc., Broomfield, CO, by letter on November 18, 2010. Firm initiated recall is ongoing.
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
“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
Estimated Resupply Dates
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: