Published on:

More Problems with Digoxin

New from Twitter (side-issue—I’ve been trying to figure out decent work-related uses for Twitter for some time. This might be it—I can get instantaneous reports from the FDA about recalls and other safety issues related to drugs and devices—if you’d like to join the club, then just go to your Twitter account, search for the FDA, and click ‘Follow’): the FDA just posted a recall from AS Medication Solutions, LLC. AS Medication distributes Digoxin 0.25 mg tablets under the Caraco brand.
Digoxin is used to treat heart failure and abnormal heart rhythms. The drugs are being pulled because some tablets may have more or less of the active ingredient. I’ve been to seminars about this drug, and my understanding is that there is a very narrow range of therapeutic benefits. The analogy is that a patient’s digoxin levels are represented by a ball balanced on the point of a pyramid—too much digoxin, even by a bit, will cause the levels to rapidly change, with disastrous results (including cardiac instability, slow heart rate, and death).

Plaintiffs’ lawyers have been advertising for digoxin cases for some time—a word first came out of the problems with Digitek tablets in April 2008 (trademarked by Activis Totowa, distributed by Mylan Pharmaceuticals Inc. under a Bertek label, and distributed by UDL Laboratories, Inc. under a UDL label). Those pills, manufactured in New Jersey, were reported to have a similar problem—some of the pills were supposedly “double-thick.” While there were verified accounts of major problems with the manufacturing facility in that instance, I don’t know of any lawyers who actually located any double-strength pills. The cases moved rapidly in the beginning but seemed to lose steam.

It’s hard to say whether there are any injuries caused by either Digitek or the Caraco brand of digoxin. It is curious that the same type of medication, though manufactured separately, has very similar manufacturing problems. Of course, if you feel you or a loved one may have been harmed by any medication, it is important to save whatever remaining medication you have—in some cases, it may be the only way to identify the specific drug used, and whether it was in fact defective.

2013 PS – These Digitek cases went absolutely nowhere.  Why?  There was absolutely no evidence that anyone actually took the defective drug.  Yes, they made at least a batch that was wrong and had a double dosage, like I said above, but these cases completely died out.